{"snapshot_at":"2026-10-14T23:38:06Z","api_version":"2.2.0","canonical":"https://recallcanary.com/data/recalls","html_url":"https://recallcanary.com/recalls","license":{"attribution":"Recall Canary","url":"https://recallcanary.com/data-license","publisher":"https://recallcanary.com/","upstream_records":{"status":"public-domain","spdx_id":null,"basis":"17 U.S.C. 105","agencies":["FDA","FSIS","CPSC","NHTSA"],"note":"For authoritative, unmodified agency text, consult the originating agency."},"editorial_layer":{"spdx_id":"CC-BY-4.0","url":"https://creativecommons.org/licenses/by/4.0/","covers":["Uniform presentation of each agency's own class or warning; Recall Canary assigns none.","display_title, display_summary, display_summary_short and consumer_action (AI-derived display text).","Curation, clustering, and hazard-tag classification decisions."]},"redistribution":{"conditions":["Attribution to \"Recall Canary\" with a link back to the source page (the `url` field on each record).","A snapshot timestamp recording when the editorial text was captured (the `snapshot_at` field on this response).","Preservation of the provenance marker where AI-generated text is redistributed (the `ai_generated` object on each record), or an equivalent in-band attribution."],"marker":"ai_generated names, per record, which fields were written by the enrichment pipeline. 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The routed model drifts over time and is deliberately not named.","disclaimer":"Nothing here is legal, medical, or safety advice."}},"filters":{"q":null,"category":null,"agency":[],"severity":[],"state":null,"date":null,"from":null,"to":null,"sort":"recent","hazard":null,"firm":null},"pagination":{"page":1,"per_page":50,"has_more":true,"next":"https://recallcanary.com/data/recalls?page=2","prev":null},"notices":[],"relaxed":false,"results":[{"record_type":"preliminary","id":"01M4XSBR1KTRRBR92BSRQ0GD5S","slug":"par-health-argatroban-injection","url":"https://recallcanary.com/recall/fda/par-health-argatroban-injection","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-health-issues-voluntary-nationwide-recall-argatroban-injection-due-presence-particulate-matter","category":"DRUG","severity":null,"status":null,"title":"Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter","display_title":"Par Health and Endo USA Argatroban Injection 250 mg/2.5 mL (100 mg/mL)","display_summary":"The injection contains particulate matter identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. Administration can cause life-threatening adverse health consequences including pulmonary emboli, occlusions of blood vessels, and inflammation of vein walls. No adverse events have been reported to date.","display_summary_short":"Argatroban Injection contains particulate matter that can cause life-threatening blood vessel blockages and inflammation.","reason":null,"firm_name":"Par Health","listed_at":"2026-10-14T00:00:00Z","product_count":0,"hazard_tags":["foreign-material"],"image_url":"https://recallcanary.com/images/5ee88e3f7292e186.webp","risk":null,"consumer_action":"Par Health is providing written notification to wholesale and hospital accounts that have received the affected lots and is arranging for return of all existing inventory through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product. Questions regarding this recall can be directed to Inmar, Inc. at 1-855-648-7909 Monday through Friday between the hours of 9 a.m. and 5 p.m. ET or by email at rxrecalls@inmar.com. For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393 Monday through Thursday between the hours of 9 a.m. and 8 p.m. ET or Friday between 9 a.m. and 6 p.m. ET.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4Y4J4016CBMHDDR0M6RGM0Y","slug":"para-bien-al-grano-box","url":"https://recallcanary.com/recall/fda/para-bien-al-grano-box","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/pan-pepin-inc-issues-allergy-alert-para-bien-al-grano-due-undeclared-sesame","category":"FOOD","severity":null,"status":null,"title":"Pan Pepin Inc. Issues Allergy Alert of Para Bien Al Grano Due to Undeclared Sesame","display_title":"Para Bien Al Grano","display_summary":"The product contains undeclared sesame.","display_summary_short":"Para Bien Al Grano contains undeclared sesame, which can cause a serious allergic reaction.","reason":null,"firm_name":"Pan Pepin Inc.","listed_at":"2026-10-14T00:00:00Z","product_count":0,"hazard_tags":["undeclared-sesame","undeclared-allergen"],"image_url":"https://recallcanary.com/images/59305259872ea5dc.webp","risk":null,"consumer_action":"Consumers with a sesame allergy who have purchased the affected products should not consume them. Consumers with questions regarding this recall may contact: Pan Pepin Inc Telephone: 787-403-7363 Email: luis.santini@panpepin.com Hours of Operation: Monday to Friday 8:00am-5:00pm. Consumers are advised to: Not consume the products if they have a sesame allergy or sensitivity. Return the products to the place of purchase for a full refund. Dispose of the products if returning them is not possible. Contact the company for additional information regarding the recall.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4Y4J45EC2KGADNQQMXSA2S2","slug":"para-bien-al-grano","url":"https://recallcanary.com/recall/fda/para-bien-al-grano","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/pan-pepin-inc-emite-alerta-por-alergenos-en-el-producto-parabien-al-grano-debido-la-presencia-de","category":"FOOD","severity":null,"status":null,"title":"Pan Pepín Inc. Emite Alerta por Alérgenos en el Producto Parabien al Grano Debido a la Presencia de  Sésamo No Declarado","display_title":"Para Bien Al Grano","display_summary":"The product contains undeclared sesame.","display_summary_short":"Para Bien Al Grano contains undeclared sesame.","reason":null,"firm_name":"Pan Pepin Inc.","listed_at":"2026-10-14T00:00:00Z","product_count":0,"hazard_tags":[],"image_url":"https://recallcanary.com/images/83cb44fb1197f8c8.webp","risk":null,"consumer_action":"Se recomienda a los consumidores: No consumir los productos si tienen alergia o sensibilidad al sésamo (ajonjolí). Devolver los productos al establecimiento donde fueron adquiridos para recibir un reembolso completo. Desechar los productos si no es posible devolverlos. Comunicarse con la compañía para obtener información adicional sobre el retiro del mercado. (787) 405-6045. Ity@delacruz.com.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4WFVGBSXS6R4N4SGYK82B56","slug":"zydus-hydrocortisone-sodium-succinate-for-injection","url":"https://recallcanary.com/recall/fda/zydus-hydrocortisone-sodium-succinate-for-injection","agency":"FDA","source_recall_id":"100017","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100017","category":"DRUG","severity":"MODERATE","status":"ONGOING","title":"Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.","display_title":"Zydus Hydrocortisone Sodium Succinate for Injection","display_summary":"The product failed impurities and degradation specifications.","display_summary_short":"Hydrocortisone Sodium Succinate for Injection failed impurities and degradation specifications.","reason":"Failed Impurities/Degradation Specifications.","firm_name":"Zydus Pharmaceuticals (USA) Inc","listed_at":"2026-10-13T00:00:00Z","product_count":1,"hazard_tags":["impurity","specification-failure"],"image_url":"https://recallcanary.com/images/fd1c7a89b4b65ac1.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4WFVGEGSD12YY6EPXD26VBR","slug":"teva-pharmaceuticals-usa-metoclopramide-tablets-usp","url":"https://recallcanary.com/recall/fda/teva-pharmaceuticals-usa-metoclopramide-tablets-usp","agency":"FDA","source_recall_id":"100013","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=100013","category":"DRUG","severity":"MODERATE","status":"ONGOING","title":"Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05","display_title":"Teva Metoclopramide Tablets","display_summary":"The product may contain foreign tablets or capsules.","display_summary_short":"Metoclopramide Tablets, USP, 5 mg may contain foreign tablets or capsules.","reason":"Presence of Foreign Tablets/Capsules","firm_name":"Teva Pharmaceuticals USA, Inc","listed_at":"2026-10-13T00:00:00Z","product_count":1,"hazard_tags":["foreign-material"],"image_url":"https://recallcanary.com/images/2756ec2a018ed901.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4WFVGH61S7NVRAV77X5K34Q","slug":"houston-rx-vantage-parkway-e-ste","url":"https://recallcanary.com/recall/fda/houston-rx-vantage-parkway-e-ste","agency":"FDA","source_recall_id":"99990","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99990","category":"DRUG","severity":"MODERATE","status":"ONGOING","title":"Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.","display_title":"Houston Rx Sermorelin and Tirzepatide/Niacinamide Injections","display_summary":"Sermorelin sterile injectable solution lacks process control. Tirzepatide/Niacinamide injection lacks assurance of sterility.","display_summary_short":"Sermorelin sterile injectable solution lacks process control, and Tirzepatide/Niacinamide injection lacks assurance of sterility.","reason":"Lack of assurance of sterility.","firm_name":"Houston Rx LLC","listed_at":"2026-10-13T00:00:00Z","product_count":2,"hazard_tags":["sterility"],"image_url":"https://recallcanary.com/images/34372a0b43eba477.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4WFVGM4PM41B7ZYRV04GD3Z","slug":"baxter-healthcare-likorall-overhead-lifts-product-description","url":"https://recallcanary.com/recall/fda/baxter-healthcare-likorall-overhead-lifts-product-description","agency":"FDA","source_recall_id":"99802","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99802","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122005NA Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122006 Product Description: LIKORALL 242 ES, WHITE Product Code: 31","display_title":"Baxter Likorall Overhead Lifts","display_summary":"A potential motor shaft breakage combined with reduced performance of the Single Fault Safety system may cause the lift strap to lower more quickly than expected. Patients are at some risk for injury if a significant fall or drop were to occur.","display_summary_short":"Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.","reason":"Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.","firm_name":"Baxter Healthcare Corporation","listed_at":"2026-10-13T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/6cb2b8a37e59f4bd.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4WFVGPVJ5GMHT6Z0JKT0SND","slug":"biofire-diagnostics-generic-name-filmarray-pneumonia-panel","url":"https://recallcanary.com/recall/fda/biofire-diagnostics-generic-name-filmarray-pneumonia-panel","agency":"FDA","source_recall_id":"99592","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99592","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144","display_title":"BioFire FilmArray Pneumonia and Joint Infection Panels","display_summary":"BioFire Diagnostics is recalling 3 products.","display_summary_short":null,"reason":"Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results","firm_name":"BioFire Diagnostics, LLC","listed_at":"2026-10-13T00:00:00Z","product_count":3,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/98e9952176a46ac3.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":false,"consumer_action":true}},{"record_type":"recall","id":"01M4MW4B4X1Y3SX7SWQCASWX23","slug":"instrumentation-laboratory-hemosll-acustar-hit-lgg","url":"https://recallcanary.com/recall/fda/instrumentation-laboratory-hemosll-acustar-hit-lgg","agency":"FDA","source_recall_id":"99843","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99843","category":"DEVICE","severity":"CRITICAL","status":"ONGOING","title":"HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic","display_title":"Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4)","display_summary":"The product may have an invalid calibration curve or negative mean bias of up to 47% with patient samples.","display_summary_short":"The HemoslL AcuStar HIT-lgG(PF-4) may have an invalid calibration curve or negative mean bias with patient samples.","reason":"Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.","firm_name":"Instrumentation Laboratory","listed_at":"2026-10-10T00:00:00Z","product_count":2,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/cbee95cf052c5f8c.webp","risk":{"word":"High risk","basis":"FDA Class I recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4H04V1JXA307Y67F4DAWEMV","slug":"par-health-brevital-sodium-vial-for-injection","url":"https://recallcanary.com/recall/fda/par-health-brevital-sodium-vial-for-injection","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-health-issues-voluntary-nationwide-recall-two-lots-brevitalr-sodium-500-mgvial-civ-methohexital","category":"DRUG","severity":null,"status":null,"title":"Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter","display_title":"Par Health Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP)","display_summary":"The product contains particulate matter identified as cellulose. Administration can cause life-threatening adverse health consequences including pulmonary emboli and blood vessel occlusions. No adverse events have been reported to date.","display_summary_short":"Brevital Sodium 500 mg/vial CIV contains particulate matter that can cause life-threatening adverse health consequences.","reason":null,"firm_name":"Par Health","listed_at":"2026-10-09T00:00:00Z","product_count":0,"hazard_tags":["foreign-material"],"image_url":"https://recallcanary.com/images/f796a6662d1c6db1.webp","risk":null,"consumer_action":"Par Health is providing written notification to wholesale accounts that have received the affected lots and are arranging for return of all existing inventory of Lots 86930 and 88623 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product. Questions regarding this recall can be directed to Inmar, Inc. at 1-844-774-1187 Monday through Friday between the hours of 9 a.m. and 5 p.m. ET or by email at rxrecalls@inmar.com. For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393 Monday through Thursday between the hours of 9 a.m. and 8 p.m. ET or Friday between 9 a.m. and 6 p.m. ET.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4HC2HKK0P51C0ZH5NQA9057","slug":"riad-s-oliva-to-go-baba-ghanouj-spicy","url":"https://recallcanary.com/recall/fda/riad-s-oliva-to-go-baba-ghanouj-spicy","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/oliva-llc-issues-allergy-alert-undeclared-sesame-baba-ghanouj-spicy-baba-ghanouj-and-hummus","category":"FOOD","severity":null,"status":null,"title":"Oliva LLC Issues Allergy Alert on Undeclared Sesame in Baba Ghanouj, Spicy Baba Ghanouj, and Hummus","display_title":"Riad's Oliva Baba Ghanouj, Spicy Baba Ghanouj, and Hummus","display_summary":"The products may contain undeclared sesame. People with an allergy or severe sensitivity to sesame risk serious or life-threatening allergic reactions if they consume them.","display_summary_short":"Baba Ghanouj, Spicy Baba Ghanouj, and Hummus may contain undeclared sesame, posing a risk of serious allergic reaction.","reason":null,"firm_name":"Oliva LLC","listed_at":"2026-10-09T00:00:00Z","product_count":0,"hazard_tags":["undeclared-sesame","undeclared-allergen"],"image_url":"https://recallcanary.com/images/01deaea56f0cfd60.webp","risk":null,"consumer_action":"Consumers who have purchased Riad’s Oliva Baba Ghanouj, Spicy Baba Ghanouj, or Hummus are urged to return it to the place of purchase for a full refund or replacement. Consumers with questions may contact the company at 203-266-5558 8 AM to 4 PM Eastern Monday through Friday. 203-266-5558.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4HC2J7T48CV5AE71PHFVYQS","slug":"starfish-seafood-cold-smoked-salmon-halibut-and-trout","url":"https://recallcanary.com/recall/fda/starfish-seafood-cold-smoked-salmon-halibut-and-trout","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/krasnyi-oktyabr-inc-recalls-starfish-seafood-trio-because-possible-health-risk","category":"FOOD","severity":null,"status":null,"title":"Krasnyi Oktyabr Inc. Recalls Starfish Seafood Trio Because of Possible Health Risk","display_title":"Starfish Seafood Trio – Cold Smoked Salmon, Halibut, Trout","display_summary":"The product may be contaminated with Listeria. It can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.","display_summary_short":"Starfish Seafood Trio may be contaminated with Listeria, which can cause serious infections.","reason":null,"firm_name":"Krasnyi Oktyabr Inc.","listed_at":"2026-10-09T00:00:00Z","product_count":0,"hazard_tags":["listeria","contamination"],"image_url":"https://recallcanary.com/images/4b3cbf742262d91e.webp","risk":null,"consumer_action":"Consumers who have purchased the recalled Starfish Seafood Trio are urged not to consume the product and to return it to the place of purchase for a full refund. Consumers with questions may contact Krasnyi Oktyabr Inc. at (718) 858-6720, Monday through Friday, from 9:00 a.m. to 5:00 p.m. Eastern Time (ET).","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98RYST9XDJ90S9617CY0H","slug":"integrated-medcraft-forward-gunshot-wound-kit","url":"https://recallcanary.com/recall/fda/integrated-medcraft-forward-gunshot-wound-kit","agency":"FDA","source_recall_id":"99948","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99948","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"FORWARD Gunshot Wound Kit; Model: AFT-GSW;","display_title":"Integrated Medcraft FORWARD Gunshot Wound Kit","display_summary":"The sterile pad in the kit may degrade over time. This degradation could cause remnants of the nonwoven pad material to dislodge on or near the wound.","display_summary_short":"The Forward Gunshot Wound Kit has a sterile pad that may degrade over time, potentially causing pad remnants to dislodge near a wound.","reason":"Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.","firm_name":"INTEGRATED MEDCRAFT LLC","listed_at":"2026-10-09T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/790113eab0440cbe.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98S116VVJ494BW7AMDG1W","slug":"si-bone-ifuse-torq-implant-system","url":"https://recallcanary.com/recall/fda/si-bone-ifuse-torq-implant-system","agency":"FDA","source_recall_id":"99868","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99868","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)","display_title":"SI-BONE iFuse TORQ Implant System","display_summary":"The pelvic fixation screws did not meet acceptance criteria for tube packaging seal integrity testing. Therefore, sterility assurance cannot be ensured.","display_summary_short":"The iFuse TORQ Implant System may not be sterile because its packaging seal integrity was not assured.","reason":"The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.","firm_name":"SI-BONE, Inc.","listed_at":"2026-10-09T00:00:00Z","product_count":1,"hazard_tags":["sterility"],"image_url":"https://recallcanary.com/images/3d1dd9739ff3977c.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98S38HJD3ZFJCHS76TX9C","slug":"ferno-washington-power-f2-powered-fastening-system-power-f2","url":"https://recallcanary.com/recall/fda/ferno-washington-power-f2-powered-fastening-system-power-f2","agency":"FDA","source_recall_id":"99861","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99861","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821","display_title":"Ferno-Washington Power F2 Powered Fastening System","display_summary":"A firmware issue may cause intermittent loss or degradation of powered functionality. This can lead to the system not operating in powered mode or reduced performance. It may interrupt or delay patient transport.","display_summary_short":"The Power F2 Powered Fastening System may have intermittent loss of powered function, causing reduced performance or delays in patient transport.","reason":"Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in patient transport.","firm_name":"Ferno-Washington Inc","listed_at":"2026-10-09T00:00:00Z","product_count":1,"hazard_tags":["software-defect"],"image_url":"https://recallcanary.com/images/53df17479e0a6385.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98TQYV01HED1N54G5BP1G","slug":"sarnova-hc-curaplex-capnography-etco2-o2-oral","url":"https://recallcanary.com/recall/fda/sarnova-hc-curaplex-capnography-etco2-o2-oral","agency":"FDA","source_recall_id":"99838","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99838","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT","display_title":"Sarnova Curaplex Capnography Oral Nasal Cannula Multipack","display_summary":"The affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.","display_summary_short":"The Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack contains pediatric nasal cannulas instead of adult ones.","reason":"Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.","firm_name":"Sarnova HC, Llc","listed_at":"2026-10-09T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/d4e60f1628bcb15b.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98TT64864B8GJKWQV4EMG","slug":"boston-scientific-naviflex-lw-pusher","url":"https://recallcanary.com/recall/fda/boston-scientific-naviflex-lw-pusher","agency":"FDA","source_recall_id":"99829","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99829","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;","display_title":"Boston Scientific NaviFlex LW Pusher and Advx Panc Stent","display_summary":"The device was incorrectly manufactured with a guidewire exit port, which is not a design feature. This could cause issues during use.","display_summary_short":null,"reason":"Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.","firm_name":"Boston Scientific Corporation","listed_at":"2026-10-09T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/00d0d9f27e97e136.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":false,"consumer_action":true}},{"record_type":"recall","id":"01M4J98TWFY5YDSM1MDRA34SDX","slug":"neuronetics-neurostar-advanced-therapy-system","url":"https://recallcanary.com/recall/fda/neuronetics-neurostar-advanced-therapy-system","agency":"FDA","source_recall_id":"99812","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99812","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number:","display_title":"Neuronetics NeuroStar Advanced Therapy Systems","display_summary":"Cables in the NeuroStar Advanced Therapy System are not in conformance with product specifications.","display_summary_short":"The NeuroStar Advanced Therapy System has cables that are not in conformance with product specifications.","reason":"Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.","firm_name":"Neuronetics, Inc.","listed_at":"2026-10-09T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/ddb6629410bd5549.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98TYP6QJ8CHB8JJ6RSCF5","slug":"cadwell-industries-iomax-cortical-module","url":"https://recallcanary.com/recall/fda/cadwell-industries-iomax-cortical-module","agency":"FDA","source_recall_id":"99774","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99774","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. Th","display_title":"Cadwell IOMAX Cortical Module","display_summary":"The device contains a defective printed circuit board assembly that may cause unintentional electrical stimulation or unintended current to the patient.","display_summary_short":"The IOMAX Cortical Module may unintentionally deliver electrical stimulation or allow unintended current to reach the patient.","reason":"Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.","firm_name":"Cadwell Industries Inc","listed_at":"2026-10-09T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/7ca13ac8aa3e7e08.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98WGNJG34YS5KRJZ92TNN","slug":"becton-dickinson-bd-phoenix-panel","url":"https://recallcanary.com/recall/fda/becton-dickinson-bd-phoenix-panel","agency":"FDA","source_recall_id":"99725","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99725","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"BD Phoenix Panel NMIC-312. Catalog Number: 449082.","display_title":"Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312","display_summary":"The panel may have quality control failures with Klebsiella pneumoniae. This could affect the CPO Ambler classification feature.","display_summary_short":"BD Phoenix Panel NMIC-312 may have quality control failures with Klebsiella pneumoniae.","reason":"Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.","firm_name":"Becton Dickinson & Co.","listed_at":"2026-10-09T00:00:00Z","product_count":2,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/3acc803909aef0e5.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98YC9HSBT3K16EVSW698V","slug":"medtronic-sofamor-danek-usa-grafton-dbm-and-grafton","url":"https://recallcanary.com/recall/fda/medtronic-sofamor-danek-usa-grafton-dbm-and-grafton","agency":"FDA","source_recall_id":"99701","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99701","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder fo","display_title":"Medtronic Grafton DBM and Grafton Plus DBM Bone Grafts","display_summary":"The donor tissue tested positive for Clostridium butyricum. If implanted, there is a possibility of clostridium infection. Medtronic is retrieving any unused product from the donor tissue.","display_summary_short":"Grafton DBM and Grafton Plus DBM may cause infection if implanted.","reason":"Medtronic identified through donor record review that the donor for Medtronic \nbatch A62881 did not meet all Medtronic donor eligibility requirements related to \nthe presence of microbial organisms.  While the batch passed finished product \nsterility testing Medtronic is retrieving any unused product manufactured from the \ndonor tissue.  \n\nDonor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection","firm_name":"Medtronic Sofamor Danek USA Inc","listed_at":"2026-10-09T00:00:00Z","product_count":1,"hazard_tags":["sterility","contamination","donor-eligibility"],"image_url":"https://recallcanary.com/images/691736a8396d83e1.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4J98YEF15HX72CA3F5WVY94","slug":"jenavalve-trilogy-delivery-catheter-size","url":"https://recallcanary.com/recall/fda/jenavalve-trilogy-delivery-catheter-size","agency":"FDA","source_recall_id":"99697","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99697","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S","display_title":"JenaValve Trilogy Delivery Catheters","display_summary":"The delivery catheter may have sleeve liner separation. This can result in difficulty or inability to deploy the heart valve device.","display_summary_short":"The JenaValve Trilogy Delivery Catheter may have sleeve liner separation that can cause difficulty or inability to deploy the heart valve device.","reason":"Delivery Catheter may  have sleeve liner separation that results in difficulty or inability  to  deploy heart valve device.","firm_name":"Jenavalve Technology Inc.","listed_at":"2026-10-09T00:00:00Z","product_count":3,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/9687995fa43cd3b6.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4EK51BK4WFX7DHYBH816PJ7","slug":"onthewei-baby-bath-seats","url":"https://recallcanary.com/recall/cpsc/onthewei-baby-bath-seats","agency":"CPSC","source_recall_id":"11014","source_url":"https://cpsc.gov/Recalls/2027/ONTHEWEI-Recalls-Baby-Bath-Seats-Due-to-Risk-of-Serious-Injury-or-Death-to-Children-from-Drowning-Violate-Mandatory-Standard-for-Infant-Bath-Seats","category":"CONSUMER_PRODUCT","severity":null,"status":"ONGOING","title":"ONTHEWEI Recalls Baby Bath Seats Due to Risk of Serious Injury or Death to Children from Drowning; Violate Mandatory Standard for Infant Bath Seats","display_title":"ONTHEWEI Baby Bath Seats","display_summary":"The bath seats are unstable and can tip over while in use. This poses a risk of serious injury or death due to drowning.","display_summary_short":"Baby bath seats can tip over and cause drowning, posing a risk of serious injury or death.","reason":"The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious injury or death due to drowning.","firm_name":"ONTHEWEI","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["drowning"],"image_url":"https://recallcanary.com/images/1cada7cf12849c65.webp","risk":null,"consumer_action":"Consumers should stop using the recalled bath seats immediately and contact ONTHEWEI for a full refund. Consumers will be asked to destroy the bath seat by writing in permanent marker “RECALLED” on the front of the bath seat, disassembling it by removing the back rest and arm restraints and cutting the three suction cups on the seat’s underside and send a photo of the destroyed bath seat showing the marked product to onthewei@outlook.com. Consumers should then dispose of the recalled product. ONTHEWEI by email at onthewei@outlook.com.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4EK51BK8D6BSMVVXF8KN91C","slug":"snow-peak-propane-fireplace-inserts-and-lava-rocks","url":"https://recallcanary.com/recall/cpsc/snow-peak-propane-fireplace-inserts-and-lava-rocks","agency":"CPSC","source_recall_id":"11017","source_url":"https://www.cpsc.gov/Recalls/2027/Snow-Peak-Recalls-Propane-Fireplace-Inserts-and-Lava-Rocks-Due-to-Risk-of-Serious-Injury-or-Death-from-Burn-and-Fire-Hazards","category":"CONSUMER_PRODUCT","severity":null,"status":"ONGOING","title":"Snow Peak Recalls Propane Fireplace Inserts and Lava Rocks Due to Risk of Serious Injury or Death from Burn and Fire Hazards","display_title":"Snow Peak Takibi Fireplace Propane Inserts and Lava Rocks","display_summary":"The lava rocks can ignite and explode when heated in the propane insert. This poses a risk of serious injury or death from burn and fire hazards.","display_summary_short":"Takibi propane inserts and lava rocks can ignite and explode when heated, posing burn and fire hazards.","reason":"The fireplace’s lava rocks can ignite and explode when heated in the propane insert, posing a risk of serious injury or death from burn and fire hazards.","firm_name":"Snow Peak USA, Inc.","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["burn","fire"],"image_url":"https://recallcanary.com/images/be4c8e0c7a6072f5.webp","risk":null,"consumer_action":"Consumers should stop using the propane insert and lava rocks fireplace accessories immediately and contact Snow Peak for a full refund. Consumers will be provided with a prepaid shipping label to return the propane insert and lava rocks. For replacement lava rocks only, the consumer can keep the propane inserts, and the firm will ship replacement lava rocks to the consumer. Do not use inserts until replacement lava rocks are received. Consumers should dispose of the recalled lava rocks in accordance with any local and state ordinances. Snow Peak USAtoll-free at 888-424-4916 from 8:30 a.m. to 5 p.m. PT Monday through Friday, email at info@snowpeak.com or online at https://www.snowpeak.com/pages/takibi-propane-insert-recall and https://www.snowpeak.com/ and click “Recalls” in the footer at the bottom of the page for more information.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4EK51BKA3W1X1RANBC3Z0S7","slug":"romorgniz-six-drawer-dressers","url":"https://recallcanary.com/recall/cpsc/romorgniz-six-drawer-dressers","agency":"CPSC","source_recall_id":"11016","source_url":"https://www.cpsc.gov/Recalls/2027/Romorgniz-Recalls-Six-Drawer-Dressers-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Hazards-Violate-Mandatory-Standard-for-Clothing-Storage-Units","category":"CONSUMER_PRODUCT","severity":null,"status":"ONGOING","title":"Romorgniz Recalls Six-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units","display_title":"Romorgniz Six-Drawer Dressers","display_summary":"The dressers are unstable if not anchored to the wall, posing tip-over and entrapment hazards that can result in serious injuries or death to children. They also violate mandatory safety standards.","display_summary_short":"Romorgniz six-drawer dressers are unstable if not anchored, posing tip-over and entrapment hazards that can cause serious injury or death to children.","reason":"The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.","firm_name":"Zhangzhou Jinhao Sen Smart Home Co., Ltd.","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["tip-over","entrapment"],"image_url":"https://recallcanary.com/images/76435a9e59639e13.webp","risk":null,"consumer_action":"Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Romorgniz for a full refund. Consumers will be asked to write in permanent marker “RECALLED” on the top, front and sides of the dresser, remove all drawers and send photos of the marked and disassembled dresser to Romorgnizrecall@outlook.com. Consumers should then dispose of the product. Romorgniz via email at Romorgnizrecall@outlook.com, online at https://www.romorgniz.store/recall.html or https://www.romorgniz.store/ and click “Recall” at the top of the page for more information.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4EK51BKBTQVR7843D76Y1MS","slug":"giant-bicycle-led-light-keys-included-with-surelock-bike-lock-sets","url":"https://recallcanary.com/recall/cpsc/giant-bicycle-led-light-keys-included-with-surelock-bike-lock-sets","agency":"CPSC","source_recall_id":"11021","source_url":"https://www.cpsc.gov/Recalls/2027/Giant-Bicycle-Recalls-LED-Light-Keys-Included-with-SureLock-Bike-Lock-Sets-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violates-Mandatory-Standard-for-Consumer-Products-with-Button-Cell-Batteries","category":"CONSUMER_PRODUCT","severity":null,"status":"ONGOING","title":"Giant Bicycle Recalls LED-Light Keys Included with SureLock Bike Lock Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries","display_title":"Giant Bicycle LED-Light Bike Lock Keys","display_summary":"The LED-light key can allow easy access to button batteries. Swallowed batteries can cause serious injuries, internal chemical burns, and death.","display_summary_short":"LED-light bike lock keys can allow easy access to button batteries, posing an ingestion hazard.","reason":"The LED-light key that was included with certain SureLock Bicycle Lock sets violates the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese’s Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.","firm_name":"Giant Bicycle, Inc.","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["ingestion","burn"],"image_url":"https://recallcanary.com/images/e84a9dbca16f4976.webp","risk":null,"consumer_action":"Consumers should stop using the recalled LED-light key that was included with certain SureLock Bicycle Lock sets immediately and contact Giant Bicycle for a $5 refund. Consumers will be asked to bring the LED key to an authorized Giant retailer to participate in the recall and receive the refund. When returning the LED-light key to a retailer, consumers will be required to bring either the complete bicycle lock purchase or a picture of the serial number on the bicycle lock in order to verify the serial number is in the scope of the recall. Consumers may continue to use the bicycle lock and non-LED-light keys included with the SureLock Bicycle Lock sets. Note: Button and Coin cell batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4EK51BKK5MHSPWPS420RJ3Z","slug":"decathlon-america-van-rysel-grvl-af-bicycles","url":"https://recallcanary.com/recall/cpsc/decathlon-america-van-rysel-grvl-af-bicycles","agency":"CPSC","source_recall_id":"11020","source_url":"https://www.cpsc.gov/Recalls/2027/Decathlon-America-Recalls-Van-Rysel-GRVL-AF-Bicycles-Due-to-Risk-of-Serious-Injury-or-Death-from-Crash-Hazard","category":"CONSUMER_PRODUCT","severity":null,"status":"ONGOING","title":"Decathlon America Recalls Van Rysel GRVL AF Bicycles Due to Risk of Serious Injury or Death from Crash Hazard","display_title":"Van Rysel GRVL AF Bicycles","display_summary":"The front lock nut on these bicycles can loosen during use, causing the front wheel to dislodge or loosen over time. This poses a crash hazard.","display_summary_short":"Van Rysel GRVL AF bicycles have a front lock nut that can loosen, causing the front wheel to dislodge and posing a crash hazard.","reason":"The recalled bicycles’ front lock nut can loosen during use, causing the front wheel to dislodge or loosen over time, posing a crash hazard.","firm_name":"Recreational Equipment, Inc. (REI)","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["crash"],"image_url":"https://recallcanary.com/images/a950dd619e9bbdc3.webp","risk":null,"consumer_action":"Consumers should stop using the recalled bicycles immediately and take them to the nearest Recreational Equipment (REI Co-op) location for a free inspection and repair service of the front fork assembly. Anyone unable to visit an REI Co-op location can contact Decathlon Customer Service directly for assistance. Recalled models can be identified by the Van Rysel Product ID on the top right of the product label under the frame, beginning with the number 5. Decathlon America at 415-408-5494 from 9 a.m. to 5 p.m. PT Monday through Friday, email at support.america@decathlon.com or online at https://www.decathlon.com/pages/product-safety-recalls or https://www.decathlon.com/ and click “Recalls” in the footer at the bottom of the page.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4EK51BKKHXFWMRY35YNWQ77","slug":"the-conqueror-avengers-medals","url":"https://recallcanary.com/recall/cpsc/the-conqueror-avengers-medals","agency":"CPSC","source_recall_id":"11019","source_url":"https://www.cpsc.gov/Recalls/2027/The-Conqueror-Recalls-Avengers-Medals-Due-to-Risk-of-Serious-Injury-or-Death-from-Magnet-Ingestion-Violate-Mandatory-Standard-for-Magnets","category":"CONSUMER_PRODUCT","severity":null,"status":"ONGOING","title":"The Conqueror Recalls Avengers Medals Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Magnets","display_title":"The Conqueror Avengers Infinity Gauntlet Medals","display_summary":"The medals violate the mandatory safety standard for magnets because the high-powered magnets may detach. When swallowed, the magnets can attract each other or other metal objects and become lodged in the digestive system, causing perforations, twisting, blockage, blood poisoning, and death.","display_summary_short":"The Avengers Infinity Gauntlet Medals have high-powered magnets that may detach, posing a deadly ingestion hazard to children.","reason":"The recalled medals violate the mandatory safety standard for magnets because the high-powered magnets may detach, posing a deadly ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.","firm_name":"The Conqueror","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["ingestion"],"image_url":"https://recallcanary.com/images/2742bf4658e8d818.webp","risk":null,"consumer_action":"Consumers should stop using the Avengers Infinity Gauntlet Medal immediately and contact The Conqueror for instructions on receiving a full refund or a replacement medal. Consumers will be asked to cut the ribbon from the medal and write “RECALLED” in permanent marker on the medal and ribbon, throw the product away and email a photo of the disposed medal and ribbon to support@theconqueror.events. The Conqueror toll-free at 833-799-0368 from 9 a.m. to 5 p.m. ET Monday through Friday, by email at support@theconqueror.events, or online at www.theconqueror.events/recall-inf or www.theconqueror.events and click “Recall” at the bottom of the page for more information.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4EK51BKYXMKPDMG7P7K7ZCT","slug":"pacearth-swing-seats","url":"https://recallcanary.com/recall/cpsc/pacearth-swing-seats","agency":"CPSC","source_recall_id":"11015","source_url":"https://www.cpsc.gov/Recalls/2027/Pacearth-Direct-Recalls-PACEARTH-Swing-Seats-Due-to-Risk-of-Serious-Injury-from-Fall-Hazard","category":"CONSUMER_PRODUCT","severity":null,"status":"ONGOING","title":"Pacearth Direct Recalls PACEARTH Swing Seats Due to Risk of Serious Injury from Fall Hazard","display_title":"PACEARTH U-Type Swing Seats","display_summary":"The seats, metal carabiners or quick links, or webbing straps can break during use. This poses a risk of serious injury due to fall hazard.","display_summary_short":"Pacearth swing seats can break during use, posing a risk of serious injury from falls.","reason":"The seats, metal carabiners or quick links, or webbing straps of the recalled swing seats can break during use, posing a risk of serious injury due to fall hazard.","firm_name":"Pacearth Direct","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["fall"],"image_url":"https://recallcanary.com/images/f915eeee0be32c0b.webp","risk":null,"consumer_action":"Consumers should stop using the recalled swing seats immediately and contact Pacearth Direct for a full refund. Consumers will be asked to write “RECALLED” on the swing seat with permanent marker, take a photo of it, including the PACEARTH logo and email to recall@pacearth.com. Pacearth Direct by email at recall@pacearth.com.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4EK51BKZW2PEFKDGE22APBS","slug":"dr-power-equipment-pilot-and-premier-trimmer-mowers","url":"https://recallcanary.com/recall/cpsc/dr-power-equipment-pilot-and-premier-trimmer-mowers","agency":"CPSC","source_recall_id":"11018","source_url":"https://www.cpsc.gov/Recalls/2027/DR-Power-Equipment-Recalls-Pilot-and-Premier-Trimmer-Mowers-Due-to-Risk-of-Serious-Injury-or-Death-from-Fire-and-Burn-Hazards","category":"CONSUMER_PRODUCT","severity":null,"status":"ONGOING","title":"DR Power Equipment Recalls Pilot and Premier Trimmer Mowers Due to Risk of Serious Injury or Death from Fire and Burn Hazards","display_title":"DR Power Equipment Pilot and Premier Trimmer Mowers","display_summary":"Grass and debris can accumulate in the trimmer mowers and ignite. This poses a risk of serious injury or death from fire and burn hazards.","display_summary_short":"The trimmer mowers can accumulate grass and debris that ignite, posing a risk of serious injury or death from fire and burn hazards.","reason":"Grass and debris can accumulate in the trimmer mowers and ignite, posing a risk of serious injury or death from fire and burn hazards.","firm_name":"Generac Power Systems Inc.","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["fire","burn"],"image_url":"https://recallcanary.com/images/975eb9ef089d6279.webp","risk":null,"consumer_action":"Consumers should stop using the recalled trimmer mowers immediately and contact DR Power Equipment for a free repair kit. If consumers have concerns about installing the repair kit, contact DR Power Equipment to schedule a free repair installation from an authorized dealer. DR Power Equipment toll-free at 800-854-3194 from 8:30 a.m. to 5 p.m. ET Monday through Friday, email at recall@drpower.com or online at http://drpower.com/recalls or www.drpower.com and click “Product Recalls” at the bottom of the page for more information.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4FR3TH7T5S36QRSAWMNYZH7","slug":"gardeners-basics-broccoli-sprouting-seeds","url":"https://recallcanary.com/recall/fda/gardeners-basics-broccoli-sprouting-seeds","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/gardeners-basics-recalls-waltham-29-broccoli-sprouting-seeds-due-possible-salmonella-contamination","category":"FOOD","severity":null,"status":null,"title":"Gardeners Basics Recalls Waltham 29 Broccoli Sprouting Seeds Due to Possible Salmonella Contamination","display_title":"Gardeners Basics Waltham 29 Broccoli Sprouting Seeds","display_summary":"The seeds may be contaminated with Salmonella. Healthy people may experience fever, diarrhea, nausea, vomiting and abdominal pain. The product was sold online nationwide.","display_summary_short":"Broccoli sprouting seeds may be contaminated with Salmonella, which can cause serious infections.","reason":null,"firm_name":"Gardeners Basics","listed_at":"2026-10-08T00:00:00Z","product_count":0,"hazard_tags":["salmonella","contamination"],"image_url":"https://recallcanary.com/images/6efbafe8b2a37a7f.webp","risk":null,"consumer_action":"Consumers should stop using the recalled seeds and they should not eat the seeds or any sprouts grown from them. Consumers should: Seal the recalled seeds and any sprouts in a bag and discard them. No return is required. Contact Gardeners Basics for recall assistance or a refund if your affected purchase has not already been refunded. If you are unsure whether your bag is affected, stop using it and contact us. Email info@gardenersbasics.com, or text or leave a voicemail at 801-769-6181 any time, seven days a week.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4FRBPRX9APWXJKW2KSEZH3P","slug":"sun-pharmaceutical-taro-pharmaceuticals","url":"https://recallcanary.com/recall/fda/sun-pharmaceutical-taro-pharmaceuticals","agency":"FDA","source_recall_id":"99977","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99977","category":"DRUG","severity":"LOW","status":"ONGOING","title":"Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.","display_title":"Sun Pharmaceutical Industries Tretinoin Cream","display_summary":"Tretinoin Cream USP, 0.05% failed impurities and degradation specifications.","display_summary_short":"Tretinoin Cream USP, 0.05% failed impurities and degradation specifications.","reason":"Failed Impurities/Degradation Specifications","firm_name":"SUN PHARMACEUTICAL INDUSTRIES INC","listed_at":"2026-10-08T00:00:00Z","product_count":3,"hazard_tags":["impurity","specification-failure"],"image_url":"https://recallcanary.com/images/7b328a1c81878ea5.webp","risk":{"word":"Low risk","basis":"FDA Class III recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4FRBPT040NTHRF0G4NE0DKB","slug":"j-j-innovative-medicine-imaavy-nipocalimab-aahu-injection","url":"https://recallcanary.com/recall/fda/j-j-innovative-medicine-imaavy-nipocalimab-aahu-injection","agency":"FDA","source_recall_id":"99972","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99972","category":"DRUG","severity":"MODERATE","status":"ONGOING","title":"IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01","display_title":"J&J Innovative Medicine Imaavy Injection","display_summary":"The product contains particulate matter.","display_summary_short":"Imaavy (nipocalimab-aahu) Injection contains particulate matter.","reason":"Presence of particulate matter.","firm_name":"J&J INNOVATIVE MEDICINE","listed_at":"2026-10-08T00:00:00Z","product_count":1,"hazard_tags":["foreign-material"],"image_url":"https://recallcanary.com/images/f9c4094424b0b940.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4FRBPV386J4HF9K7KE2KXK3","slug":"apothecary-pharma-sterile-multi-dose-vial","url":"https://recallcanary.com/recall/fda/apothecary-pharma-sterile-multi-dose-vial","agency":"FDA","source_recall_id":"99952","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99952","category":"DRUG","severity":"MODERATE","status":"ONGOING","title":"Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.","display_title":"Apothecary Pharma NAD+ and Tirzepatide Injections","display_summary":"Tirzepatide Injection lacks assurance of sterility.","display_summary_short":"Tirzepatide Injection lacks assurance of sterility.","reason":"Lack of Assurance of Sterility","firm_name":"Apothecary Pharma LLC","listed_at":"2026-10-08T00:00:00Z","product_count":2,"hazard_tags":["sterility"],"image_url":"https://recallcanary.com/images/9a4bd7847f1ad545.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4FRBPW5C7J9ADWZNXX7CT2Q","slug":"carolina-infusion","url":"https://recallcanary.com/recall/fda/carolina-infusion","agency":"FDA","source_recall_id":"99867","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99867","category":"DRUG","severity":"MODERATE","status":"ONGOING","title":"TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;","display_title":"Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables","display_summary":"The products lack assurance of sterility.","display_summary_short":"Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables lack assurance of sterility.","reason":"Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.","firm_name":"Carolina Infusion, LLC","listed_at":"2026-10-08T00:00:00Z","product_count":16,"hazard_tags":["sterility"],"image_url":"https://recallcanary.com/images/1e475dd71085d8ad.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4FRBQM2TD5CM3TN5G8ZC2VJ","slug":"j-k-patisserie-bakery-lemon-blueberry-loaf","url":"https://recallcanary.com/recall/fda/j-k-patisserie-bakery-lemon-blueberry-loaf","agency":"FDA","source_recall_id":"99823","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99823","category":"FOOD","severity":"MODERATE","status":"ONGOING","title":"Lemon Blueberry Loaf packaged in a cardboard box; Ingredients: King midas flour, Veribest pastry flour, Granulated Sugar, Blueberries frozen IQF, Milk, Canola Oil, Eggs, Lemon Juice, Lemon Zest, Baking Powder, Lemon Extract, Salt; Contains: Wheat, Milk, Eggs","display_title":"J K Patisserie Chocolate Chip Cookies, Croissants and Lemon Blueberry Loaf","display_summary":"Soy is not declared on Lemon Blueberry Loaf and Chocolate Chip Cookies. Egg is not declared on Croissant. Lemon Blueberry Loaf also contains undeclared soybean oil and soy lecithin.","display_summary_short":"J K Patisserie & Bakery is recalling Lemon Blueberry Loaf and Chocolate Chip Cookies because soy was not declared, and Croissant because egg was not declared.","reason":"Product contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement.","firm_name":"J K Patisserie & Bakery LLC","listed_at":"2026-10-08T00:00:00Z","product_count":3,"hazard_tags":["undeclared-soy","undeclared-allergen","undeclared-egg"],"image_url":null,"risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4BX7KPRTN4RKG3P6MQTQDWM","slug":"babies-magic-tea-brand-baby-sleep-gripe-water-bottle","url":"https://recallcanary.com/recall/fda/babies-magic-tea-brand-baby-sleep-gripe-water-bottle","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/pacific-health-sciences-voluntarily-recalls-one-lot-babies-magic-tea-brand-baby-sleep-gripe-water","category":"DRUG","severity":null,"status":null,"title":"Pacific Health Sciences Voluntarily Recalls One Lot of Babies' Magic Tea Brand Baby Sleep Gripe Water Dietary Supplement","display_title":"Babies' Magic Tea Brand Baby Sleep Gripe Water","display_summary":"The product contains undeclared ethanol, methanol, and isopropanol. Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product. No adverse events have been reported to date.","display_summary_short":"Babies' Magic Tea brand Baby Sleep Gripe Water contains undeclared ethanol, methanol, and isopropanol, which may pose a risk.","reason":null,"firm_name":"Pacific Health Sciences","listed_at":"2026-10-07T00:00:00Z","product_count":0,"hazard_tags":[],"image_url":"https://recallcanary.com/images/2720a2798fff6470.webp","risk":null,"consumer_action":"Consumers, parents, and caregivers should stop using any product from Lot 25122bw and either discard it or return it to the place of purchase for a refund. Anyone who experiences symptoms after using the product should seek medical attention and contact Pacific Health Sciences. Contact Information For questions or to report a reaction, contact Pacific Health Sciences at 310-457-1775 or myorder@pacifichealth.com, Monday through Thursday, 9:30 a.m. to 5:00 p.m. Pacific Time. Adverse reactions may also be reported to the FDA MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. To report by mail or fax, download a form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request one.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4BX7KWKQ6WJ4EZY21YFRZR9","slug":"rapture-preworkout-dietary-supplement-powder","url":"https://recallcanary.com/recall/fda/rapture-preworkout-dietary-supplement-powder","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/leader-formulas-llc-issues-voluntary-nationwide-recall-rapture-preworkout-due-presence-13","category":"DRUG","severity":null,"status":null,"title":"Leader Formulas, LLC. Issues Voluntary Nationwide Recall of RAPTURE Preworkout Due to the Presence of 1,3-Dimethylamylamine (DMAA)","display_title":"Leader Formulas, LLC. RAPTURE Preworkout","display_summary":"The product contains DMAA. Using it can result in elevated blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.","display_summary_short":"Rapture Preworkout contains DMAA, which can lead to cardiovascular problems.","reason":null,"firm_name":"Leader Formulas, LLC.","listed_at":"2026-10-07T00:00:00Z","product_count":0,"hazard_tags":[],"image_url":"https://recallcanary.com/images/ef7907ae568bac0c.webp","risk":null,"consumer_action":"Consumers who have purchased the RAPTURE Preworkout products which are being recalled should stop using the products and return to the place of purchase for a full refund. Consumers with questions regarding this recall may contact Leader Formulas, LLC. by email at Patrick@leaderformulas.com or by phone at 832-855-7562 Monday through Friday 9 AM to 5 PM CT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"preliminary","id":"01M4C8VFM41WSKSPDDS87WR14S","slug":"eden-brothers-broccoli-seeds-calabrese","url":"https://recallcanary.com/recall/fda/eden-brothers-broccoli-seeds-calabrese","agency":"FDA","source_recall_id":null,"source_url":"https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/eden-brothers-recalls-calabrese-broccoli-seeds-due-possible-salmonella-contamination","category":"FOOD","severity":null,"status":null,"title":"Eden Brothers Recalls Calabrese Broccoli Seeds Due to Possible Salmonella Contamination","display_title":"Eden Brothers Calabrese Broccoli Seeds","display_summary":"The seeds may be contaminated with Salmonella. Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. The lot number is printed on the seed packet or bag.","display_summary_short":"Calabrese Broccoli Seeds may be contaminated with Salmonella, which can cause serious infections.","reason":null,"firm_name":"Eden Brothers LLC","listed_at":"2026-10-07T00:00:00Z","product_count":0,"hazard_tags":["salmonella","contamination"],"image_url":"https://recallcanary.com/images/411f83480d74c17f.webp","risk":null,"consumer_action":"Consumers who have the recalled seeds should stop using them. They should not plant, sprout, eat or share them, and should not use them to grow microgreens. Retailers and distributors who resold or further distributed the recalled seeds should stop distribution right away, set aside and destroy remaining inventory, notify their customers, and complete the reply form. Customers with questions can contact Eden Brothers Customer Service at 855-440-2929, Monday–Friday, 9 a.m. to 5 p.m. ET, or email service@edenbrothers.com. Seal the seeds in a bag and throw them away in household trash rather than compost. Wash hands and any surfaces or containers that touched the seeds.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H8P6C3H9CEYRWSH2RS89","slug":"cronus-pharma-anased-equine-injection-xylazine-injection","url":"https://recallcanary.com/recall/fda/cronus-pharma-anased-equine-injection-xylazine-injection","agency":"FDA","source_recall_id":"99950","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99950","category":"DRUG","severity":null,"status":"ONGOING","title":"AnaSed Equine Injection, xylazine injection, 100 mg/mL, Sedative, 50 mL, Manufactured for: Cronus Pharma LLC, East Brunswick, NJ 08816, Made in India, NDC 69043-043-05; NADA 140-442; for use in horses.","display_title":"Cronus Pharma AnaSed Equine Injection","display_summary":"AnaSed Equine Injection has discoloration. The discoloration can affect the product. It is for use in horses.","display_summary_short":"AnaSed Equine Injection, a sedative for horses, has discoloration.","reason":"Due to market complaints pertaining to product discoloration.","firm_name":"Cronus Pharma","listed_at":"2026-10-07T00:00:00Z","product_count":1,"hazard_tags":["quality-defect"],"image_url":"https://recallcanary.com/images/21baa26092475577.webp","risk":null,"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H8PH2MZNN26S09RQ55XX","slug":"queso-palmita-generic-name-pastel-de-queso-cheese-pie","url":"https://recallcanary.com/recall/fda/queso-palmita-generic-name-pastel-de-queso-cheese-pie","agency":"FDA","source_recall_id":"99933","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99933","category":"FOOD","severity":"MODERATE","status":"ONGOING","title":"QUESO PALMITA. Generic Name: Pastel de Queso (Cheese Pie). Intended use: Human consumption. Condition: Frozen. Shelf life or expected life: 90 days. Type of packaging: Vacuum, resealable package. Net weight: 1.2 lbs. UPC: 094922980045.","display_title":"Queso Palmita Frozen Pastel de Queso Cheese Pie","display_summary":"The product has undeclared milk.","display_summary_short":"Queso Palmita cheese pie has undeclared milk.","reason":"Undeclared milk, cheese declared","firm_name":"QUESO PALMITA GP LLC","listed_at":"2026-10-07T00:00:00Z","product_count":1,"hazard_tags":["undeclared-milk","undeclared-allergen"],"image_url":"https://recallcanary.com/images/71bbcc8acb43188b.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H8PZCQ7A1MT6F49H3M2A","slug":"steris-hexavue-focus-integration-system","url":"https://recallcanary.com/recall/fda/steris-hexavue-focus-integration-system","agency":"FDA","source_recall_id":"99856","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99856","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18","display_title":"Steris HexaVue Focus Integration System","display_summary":"A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.","display_summary_short":"HexaVue Focus Integration System may mismatch patient information on manually printed images, causing documentation discrepancies.","reason":"A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.","firm_name":"Steris Corporation","listed_at":"2026-10-07T00:00:00Z","product_count":1,"hazard_tags":["software-defect"],"image_url":"https://recallcanary.com/images/0084285fc826740f.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H8QCSR4AC8HE23N3K2FC","slug":"lemaitre-vascular-tuftex-over-the-wire-embolectomy-catheter","url":"https://recallcanary.com/recall/fda/lemaitre-vascular-tuftex-over-the-wire-embolectomy-catheter","agency":"FDA","source_recall_id":"99836","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99836","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;","display_title":"LeMaitre Vascular TufTex Over-the-Wire Embolectomy Catheter","display_summary":"The catheter failed in process testing related to the amount of pull force it can sustain. This can cause the balloon components to fail.","display_summary_short":"The TufTex Over-the-Wire Embolectomy Catheter can fail under pull force, causing balloon components to fail.","reason":"Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.","firm_name":"LeMaitre Vascular, Inc.","listed_at":"2026-10-07T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/dd05469be69aa19a.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H947QGK796Z7Z5647T28","slug":"mindray-ds-usa-epm-series-patient-monitor","url":"https://recallcanary.com/recall/fda/mindray-ds-usa-epm-series-patient-monitor","agency":"FDA","source_recall_id":"99828","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99828","category":"DEVICE","severity":"LOW","status":"ONGOING","title":"ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A","display_title":"Mindray Patient Monitors and Telemetry Monitoring Systems","display_summary":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions.","display_summary_short":"The ePM Series Patient Monitor has manual descriptions that may be insufficient or require clarification regarding alarm functions.","reason":"Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions","firm_name":"Mindray DS USA, Inc.","listed_at":"2026-10-07T00:00:00Z","product_count":8,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/fecdb850a68d5335.webp","risk":{"word":"Low risk","basis":"FDA Class III recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H94KP697XJ7C0HRTW3SH","slug":"intellijoint-navigation-system-workstation-g2-configured","url":"https://recallcanary.com/recall/fda/intellijoint-navigation-system-workstation-g2-configured","agency":"FDA","source_recall_id":"99821","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99821","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249","display_title":"Intellijoint Navigation System and Intellijoint HIP Systems","display_summary":"The system's workstation may contain a 15-inch MacBook Pro battery that may overheat. This can pose a fire safety risk.","display_summary_short":"The Intellijoint Navigation System may contain a MacBook Pro battery that can overheat and pose a fire safety risk.","reason":"A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.","firm_name":"Intellijoint Surgical, Inc.","listed_at":"2026-10-07T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/419e75ca58079ad1.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H94YQ4TYE0G2X6V79E23","slug":"canon-medical-system-usa-alphenix-infx-8000c-b5","url":"https://recallcanary.com/recall/fda/canon-medical-system-usa-alphenix-infx-8000c-b5","agency":"FDA","source_recall_id":"99817","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99817","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"Alphenix INFX-8000C/B5","display_title":"Canon Medical Alphenix INFX-8000C/B5","display_summary":"Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift. This can result in positional, imaging, or patient misalignment and a longitudinal motion error.","display_summary_short":"The Alphenix INFX-8000C/B5 has bolts that may loosen, causing the tabletop to shift and misalignment.","reason":"Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error","firm_name":"Canon Medical System, USA, INC.","listed_at":"2026-10-07T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/d6103d378adcc365.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H95DWP7GFRY7QAZSCJ4R","slug":"polymedco-inc-polymedco-sediplast-model-catalog","url":"https://recallcanary.com/recall/fda/polymedco-inc-polymedco-sediplast-model-catalog","agency":"FDA","source_recall_id":"99810","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99810","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;","display_title":"Polymedco Sediplast","display_summary":"During use, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially releasing blood and exposing the operator or work area to a biological hazard.","display_summary_short":"Sediplast tubes may resist insertion, causing cap ejection and blood exposure.","reason":"During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).","firm_name":"POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC","listed_at":"2026-10-07T00:00:00Z","product_count":1,"hazard_tags":["device-defect"],"image_url":"https://recallcanary.com/images/528a521422322966.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5H95S0RP9JGFEAFHEHYXF","slug":"avid-medical-davinci-trucustom-bundle","url":"https://recallcanary.com/recall/fda/avid-medical-davinci-trucustom-bundle","agency":"FDA","source_recall_id":"99808","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99808","category":"DEVICE","severity":"MODERATE","status":"ONGOING","title":"DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;","display_title":"AVID Medical Custom Surgical Procedure Kits","display_summary":"The product may be contaminated with a lubricant used during the manufacturing process.","display_summary_short":"Davinci Trucustom Bundle may be contaminated with a lubricant used during manufacturing.","reason":"Product may be potentially contaminated with a lubricant used during the manufacturing process.","firm_name":"AVID Medical, Inc.","listed_at":"2026-10-07T00:00:00Z","product_count":15,"hazard_tags":["contamination"],"image_url":"https://recallcanary.com/images/eefe127a8133ce9d.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4D5HDQCSXJAHKR5P86AT5RY","slug":"sweet-sensi-elevated-edibles-hybrid-gum-drops","url":"https://recallcanary.com/recall/fda/sweet-sensi-elevated-edibles-hybrid-gum-drops","agency":"FDA","source_recall_id":"99442","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99442","category":"FOOD","severity":"MODERATE","status":"ONGOING","title":"Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC. Product is packaged in sealable & flexible gold, purple and black metallic plastic mylar pouch and is sold in two sizes: 1) Net wt. Approx. 2.1oz (60g) 10 count and 2) Net wt. 6.3oz (180g) 30 count. Batch #1811, Manufactur","display_title":"Sweet Sensi Elevated Edibles Hybrid Gum Drops","display_summary":"Staphylococcus aureus was detected in the product.","display_summary_short":"Sweet Sensi Elevated Edibles Hybrid Gum Drops contain Staphylococcus aureus.","reason":"Staphylococcus aureus detected in product.","firm_name":"SWEET SENSI","listed_at":"2026-10-07T00:00:00Z","product_count":1,"hazard_tags":["contamination"],"image_url":"https://recallcanary.com/images/37f4a9532b80c46c.webp","risk":{"word":"Moderate risk","basis":"FDA Class II recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}},{"record_type":"recall","id":"01M4Q1F5H10WKVWYSH293H7GF1","slug":"diagnostic-automated-blood-grouping-and-antibody-test-system","url":"https://recallcanary.com/recall/fda/diagnostic-automated-blood-grouping-and-antibody-test-system","agency":"FDA","source_recall_id":"98557","source_url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98557","category":"DRUG","severity":"LOW","status":"TERMINATED","title":"Erytra Automated Blood Grouping and Antibody Test System, Templates Pack versions 15.0.0 and 16.0.0, Model no. 210400, 210401","display_title":"Diagnostic Grifols Erytra and Erytra Eflexis Automated Blood Grouping and Antibody Test Systems","display_summary":"The system has an incorrect configuration for serial titration of antibodies. This can lead to minor variations in titration results, up to 1 titre, within generally accepted variability.","display_summary_short":"The Erytra blood grouping system has an incorrect configuration that can cause minor variations in titration results.","reason":"Diagnostic Grifols S.A has identified an issue in the technique definition for serial titration of antibodies using distributed DG Gel 8 Neutral cards, as configured in Templates Pack versions 15.0 and 16.0 for the U.S. market.  This incorrect configuration can lead to minor variations in titration results (up to 1 titre), which remains within the generally accepted variability for semi-quantitative titration techniques. The potential affected products are Automated Blood Grouping and Antibody Test System 210400 Erytra and 210600 Erytra Eflexis.","firm_name":"Diagnostic Grifols, S.A.","listed_at":"2026-10-07T00:00:00Z","product_count":2,"hazard_tags":[],"image_url":"https://recallcanary.com/images/1ad67870c18181b5.webp","risk":{"word":"Low risk","basis":"FDA Class III recall","explained_at":"https://recallcanary.com/how-risk-is-rated"},"consumer_action":"The FDA notice gives no instructions for consumers.","ai_generated":{"display_title":true,"display_summary":true,"display_summary_short":true,"consumer_action":true}}]}