FDA•CRITICAL
IQF Blueberries
Oregon Potato Company is recalling IQF blueberries in 30 lb. cases and 1,400 lb. totes due to potential Listeria monocytogenes contamination.
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FDA•LOWEptifibatide Injection 75 mg/100 mLSlate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.
FDA•CRITICALErbe Flexible CryoprobeErbe is recalling Flexible Cryoprobes (REF 20402-401) because they may rupture or burst during activation.
4 products
FDA•MODERATEOlympus Endoscope Suction ValvesOlympus is recalling MAJ-1443 and MAJ-1444 endoscope suction valves due to compatibility issues with specific automated reprocessors.
4 products
FDA•MODERATEXZL Jelly SnacksXZL Jelly Snacks are recalled due to undeclared FD&C Yellow #5, Yellow #6, and Red #40 food dyes.
FSIS•CRITICALCS Beef Packers Ground Beef ProductsCS Beef Packers recalls 22,912 lbs of ground beef (case codes 18601, 19583, 19563) over E. coli O145 contamination; do not serve.
3 products
FDA•CRITICALJunebar Chocolate Cherry Snack BarJunebar Chocolate Cherry Snack Bar is recalled due to undeclared milk and soy allergens.
4 products
FDA•CRITICALWhite Vein Advanced Alkaloids Chewable TabletsShaman Botanicals is recalling White Vein Advanced Alkaloids Chewable Tablets due to higher-than-labeled levels of 7-hydroxymitragynine.
2 products
FDA•MODERATEBurlington Medical Wrap ApronsBurlington Medical is recalling Wrap Aprons due to potential attenuation degradation that may reduce their protective lifespan.
13 products
FDA•MODERATEEmbrace Shoulder Instrument Drill TowerWaldemar Link is recalling the Embrace Shoulder Instrument Drill Tower (645-081/62) due to incorrect article numbers in the surgical manual.
2 products
FDA•MODERATEBD Alaris System with Guardrails Suite MXBD Alaris System labeling lacks required TLS version specification for secure Wi-Fi communication with Point-of-Care Units.
FDA•MODERATEWellsley Farms Farm-Raised Atlantic SalmonWellsley Farms Farm-Raised Atlantic Salmon (32 oz) recalled for Listeria monocytogenes contamination.
FDA•MODERATEVergani 1944 Milano Pandoro Classico Gluten FreeItalianway Import is recalling Vergani 1944 Milano Pandoro Classico Gluten Free due to potential Teflon fragment contamination.
FDA•MODERATEAdbry (tralokinumab-ldrm) Injection 300 mg/2mLLEO Pharma is recalling Adbry injection autoinjectors (NDC 50222-350-91, 50222-350-02) due to wool fiber contamination affecting sterility.
FDA•MODERATEOrtho Dev. Trimax Lantern Knee Drill PlateOrtho Dev. Trimax Drill Plates for the Lantern Knee System are recalled due to a manufacturing error causing excessive bone cut depth.
2 products
FDA•MODERATEArtegraft Vascular GraftLeMaitre Vascular is recalling the Artegraft Vascular Graft due to a labeling mix-up on the outer packaging.
FDA•MODERATEPuracol and Puracol Plus Collagen Wound DressingsMedline is recalling Puracol collagen wound dressings due to elevated endotoxin levels that may cause severe inflammatory responses.
FDA•MODERATEEndoVive Safety PEG KitBoston Scientific is recalling EndoVive Safety PEG Kits due to potentially compromised sterile packaging on the included ChloraPrep swabsticks.
FDA•MODERATEFrozen Cooked Medium ShrimpH & N Group is recalling 1 lb bags of frozen cooked medium shrimp due to potential Cesium-137 contamination.
FDA•MODERATEHortex Spring Vegetable MixHortex Spring vegetable mix is being recalled due to potential glass contamination.
FDA•MODERATECetrorelix Acetate for Injection Kit 0.25 mgMeitheal Pharmaceuticals recalls Cetrorelix Acetate injection kits (NDC 71288-558-90) due to missing or duplicated needles.
FDA•MODERATERefleXion X1 Radiotherapy System Model RXM1000RefleXion X1 Radiotherapy System Model RXM1000 recalled for software defect causing incorrect radiation dose delivery.
FDA•MODERATEID NOW Influenza A & B 2 Test KitAbbott is recalling ID NOW Influenza A & B 2 test kits due to a higher-than-expected rate of invalid test results.
FDA•MODERATEsmart & simple Turmeric PelletsSmartPak Equine is recalling smart & simple Turmeric Pellets due to elevated aflatoxin levels.
FDA•CRITICALLobster and Crab RavioliPerfect Pasta is recalling Lobster and Crab Ravioli due to undeclared shrimp, crab, lobster, pollock, whiting, and soy allergens.
FDA•MODERATEValley Springs 100% Natural Bottled WaterValley Springs is recalling 100% Natural Bottled Water in 1 Gal jugs due to insanitary bottling conditions.
4 products
FDA•MODERATEArtelon FlexBand Dynamic MatrixInternational Life Sciences is recalling the Artelon FlexBand Dynamic Matrix due to failure to meet bacterial endotoxin testing requirements.
3 products
FDA•CRITICALTRUE METRIX Blood Glucose Meter Owner's BookletsTrividia Health is recalling TRUE METRIX blood glucose meter manuals due to inadequate instructions for the E-5 error code.
7 products
FDA•MODERATEBD Kiestra ReadABD Kiestra ReadA modules may experience connectivity issues after a reboot, potentially delaying plate retrieval.
- Device RecallFDA•LOWDatascope Cardiosave Battery Charging Station
Datascope is recalling the Cardiosave Battery Charging Station due to a design defect in the left bay that prevents proper battery charging.
FDA•MODERATEHitachi Proton Beam Therapy SystemHitachi is recalling the Proton Beam Therapy System (PROBEAT-FR) due to a software anomaly that may cause patient positioning discrepancies.
2 products
FDA•MODERATETippy Toes Apple Pear Banana Baby FoodTippy Toes Apple Pear Banana baby food is being recalled due to potential patulin contamination.
FDA•MODERATEThiamine HCl InjectionFagron Sterile Services is recalling Thiamine HCl 500 mg injection due to a lack of assurance of sterility.
5 products
FDA•MODERATECampy CVA MediumRemel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.
FDA•MODERATESTA Liatest D-Di KitDiagnostica Stago is recalling the STA Liatest D-Di kit due to a positive bias in D-Dimer measurements that may cause inaccurate results.
2 products
FDA•MODERATEDexamethasone Sodium Phosphate Injection, USP 100 mg/10 mLSomerset Therapeutics is recalling Dexamethasone Sodium Phosphate Injection (NDC 70069-025-10/01) due to out-of-specification impurities at expiry.
FDA•MODERATESTA Liatest Free Protein SDiagnostica Stago is recalling STA Liatest Free Protein S kits due to the risk of inaccurate test results for normal patient plasma levels.
FDA•MODERATEReact Health PHOENIX 5L Oxygen ConcentratorReact Health PHOENIX 5L Oxygen Concentrator recalled due to devices not meeting quality specifications.
FDA•MODERATEIvenix Infusion System Large Volume PumpFresenius Kabi is recalling the Ivenix Infusion System LVP due to a risk of the cassette loading lever breaking during use.
FSIS•CRITICALMays Chemical Company Frozen Pork Boneless LoinsMays Chemical recalls 46,315 lbs of frozen pork boneless loins imported without U.S. reinspection; discard or return.
FDA•MODERATEPure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep ResetPure Solutions recalling 1 fl oz sleep formula bottles due to undeclared milk allergen from bovine colostrum.
FDA•MODERATECoco's Italian Market Cannoli Making KitCoco's Italian Market is recalling its 8 oz. Cannoli Making Kit due to undeclared wheat and milk allergens.
2 products
FDA•CRITICALPrime Food Processing Dried Croaker FishPrime Food Processing is recalling Dried Croaker Fish due to the risk of botulism from uneviscerated fish.
FDA•LOWPitavastatin Tablets, 2 mgNorthstar Rx LLC is recalling Pitavastatin Tablets, 2 mg (NDC 72603-479-01) due to a foreign 1 mg tablet found in bottles.
FDA•MODERATEEquinoxe Ergo Modular Impactor HandleExactech is recalling the Equinoxe Ergo Modular Impactor Handle due to a missing cross-pin that may cause device failure.
2 products
FDA•MODERATEImactis CT-Navigation SystemGE Medical Systems is recalling Imactis CT-Navigation System (Models E85101LA, E85101LP) due to potential needle trajectory/tip position discordance.
FDA•MODERATEIBA Proton Therapy System PROTEUS 235IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.
FDA•MODERATEPro Numb Tattoo Numbing SprayPro Numb is recalling 5% Lidocaine Tattoo Numbing Spray due to cGMP manufacturing deviations.
2 products
FDA•MODERATEB. Braun Winged Infusion SetsB. Braun is recalling 21GA Winged Infusion Sets (Model 7M2802) due to the risk of needle tips being dull, blunt, or breaking during use.
3 products
FDA•MODERATEMICS3 Angled Sagittal Saw AttachmentHowmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because external screws may loosen and detach during use.