FDA•MODERATE
Halyard Standard Line Insertion Pack
AVID Medical recalls Halyard Standard Line Insertion Pack (Model PVHM234-01) over silicone seal defects causing leakage.
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Back to home ←- Device RecallFDA•MODERATEEmano Flow v2.0.0
Emano Flow v2.0.0 recalled due to audio sampling mismatch causing biased flow rate and volume estimates.
FDA•MODERATETheraSphere 360 Y-90 Management PlatformBoston Scientific recalls TheraSphere 360 Y-90 Platform due to software anomaly causing incorrect dose calculations.
FDA•MODERATEOlympus High Flow Insufflation Unit UHI-4Olympus recalls UHI-4 insufflation unit over unexpected display shutdown and air delivery loss.
FDA•MODERATEAXP Processing Bag SetThermoGenesis recalls AXP Processing Bag Set, Model 8-5101, over stopcock particulates in sterile fluid path.
FDA•CRITICALMedline HIP CDS-LF KitMedline is recalling specific lots of procedure kits containing Bupivacaine ampules due to a quality issue that could cause drug ineffectiveness.
4 products
FDA•MODERATEPeter Rabbit Organics Banana & Strawberry Fruit PureePT Organics recalls Peter Rabbit Organics Banana & Strawberry puree pouches due to possible plastic strands.
2 products
FDA•CRITICALSpicy Breakfast BurritosM.G. Foods recalls Spicy Breakfast Burritos due to undeclared soy allergen.
FDA•CRITICALOrganic Moringa PowderGreen Jeeva is recalling bulk 15kg bags of Organic Moringa Powder (code GJ96) due to potential Salmonella contamination.
FDA•MODERATEBrooklyn Roasting Cold Brew ConcentrateBrooklyn Roasting recalls cold brew concentrate 2.5gal over possible botulism risk.
FDA•MODERATEVentriculostomy KitMedtronic is recalling the Ventriculostomy Kit due to endotoxin levels that exceed safety limits for cerebrospinal fluid contact.
FDA•LOWShandong Ling Xian Food: 6 Serve Hot Or Cold IngredientsIsland Pacific and Nautilus imitation crab sticks and flakes recalled for undeclared STTP.
6 products
FDA•MODERATEPenumbra RED 68 Reperfusion CatheterPenumbra is recalling the RED 68 Reperfusion Catheter due to a manufacturing issue that may cause the device to fracture during use.
FDA•MODERATEWilcox BOSS Xe Aiming LasersWilcox is recalling all BOSS Xe aiming lasers to implement a safety-related software enhancement.
- Device RecallFDA•MODERATE3mensio Vascular Fenestrated Workstation Software
3mensio software may report inaccurate cardiovascular measurements when analyzing specific Philips 3D echo datasets.
FDA•MODERATESilent Nite Sleep ApplianceThe Silent Nite Sleep Appliance (Model SILNT) is being recalled because it lacks required FDA clearance.
FDA•LOWLidolog KitLidolog Kit is being recalled because the label wrap obscures the barcode, making it difficult to scan.
2 products
FDA•MODERATEOlympus 4K UHD LCD MonitorOlympus is recalling the 4K UHD LCD Monitor (model OEV321UH) due to a potential connector fault that may cause image loss or abnormalities.
FDA•MODERATEAVID Medical Eye Pack Convenience KitAVID Medical is recalling the Eye Pack convenience kit (Model LVEY27) due to an incorrect concentration of Betadine solution.
FDA•MODERATESeaSpine Polyaxial HeadSeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.
FDA•CRITICALZen Principle Moringa Leaf PowderZen Principle Moringa Leaf Powder recalled over possible Salmonella.
FDA•CRITICALCetirizine Hydrochloride Tablets 5 mgRising Pharma recalls Cetirizine HCl 5 mg tablets due to ranitidine cross-contamination.
FDA•CRITICALOLA-OLA Pounded Yam (Iyan)Fayus recalls OLA-OLA Pounded Yam for undeclared milk allergen.
FDA•CRITICALTaylor Farms de Mexico S. de: 21 productsTaylor Farms recalls 21 lettuce products over Cyclospora risk.
21 products
FDA•MODERATECyproheptadine Hydrochloride SyrupRising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.
FDA•MODERATELevothyroxine Sodium Tablets 25 mcgMajor Pharmaceuticals recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
FDA•MODERATEAmlodipine and Olmesartan Medoxomil TabletsAscend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) due to failed dissolution specifications.
FDA•LOWTrokendi XR Topiramate ER Capsules 25mgSupernus recalls Trokendi XR 25mg capsules over failed dissolution specs.
3 products
FDA•MODERATEVintage Roots Root Beer SyrupVintage Roots Root Beer Syrup recalled over unapproved sassafras bark additive.
FDA•LOWAscend Laboratories: Multiple Dabigatran Etexilate CapsulesAscend recalls Dabigatran etexilate capsules (110 mg, 150 mg) over impurity test failures.
2 products
FDA•MODERATEDivalproex Sodium Delayed-Release Tablets 500 mgBionpharma recalls Divalproex Sodium 500 mg tablets due to foreign tablets/capsules.
FDA•MODERATEFerno Power F2 Powered Fastening SystemFerno is recalling the Power F2 Powered Fastening System due to a risk of the rail mechanism lodging and preventing stretcher movement.
FDA•MODERATEHotline Fluid Warming SetICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.
FDA•MODERATEParagon 28 Phantom Intramedullary Nail System Guide RodParagon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.
FDA•MODERATEBoston Scientific FARASTAR PFA GeneratorBoston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.
FDA•MODERATEFARASTAR Ablation Generator and FARAPOINT CatheterBoston Scientific recalls FARASTAR generator and ablation catheter due to missing IFU info for FARAPOINT catheter.
3 products
FDA•MODERATEApheresis Platelets, Leukocytes Reduced, IrradiatedLifeSouth is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated, due to failure to meet platelet yield specifications.
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific recalls FARADRIVE Steerable Sheath Clear IDE over valve damage risk that may cause air embolism.
4 products
FDA•MODERATETosoh ST AIA-Pack TestosteroneTosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
FDA•MODERATEBD ChloraPrep Clear ApplicatorsCareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.
FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor gain causing inaccurate output.
3 products
FDA•MODERATEMedline Total Knee Pack Mixing Bowls and SpatulasMedline recalls Total Knee Pack kits with Zimmer Biomet mixing bowls and spatulas over sterility risk.
2 products
FDA•MODERATEVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemVasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
FDA•MODERATEMedtronic DLP Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material with trace blood.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic is recalling replacement brush heads over a choking hazard from breakage.
2 products
FDA•MODERATECleviprex Injectable EmulsionChiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.
FDA•MODERATEAmy's Organic Lentil Soup Light in SodiumAmy's is recalling 14.5 oz cans of Organic Lentil Soup Light in Sodium due to potential spoilage.
FDA•MODERATEOla-Ola Pounded GroundnutsOla-Ola Pounded Groundnuts are recalled due to undeclared peanuts, posing a risk to consumers with peanut allergies.
FDA•MODERATEBell Pharmaceuticals: Multiple Carbamide Peroxide ProductsBell Pharmaceuticals recalls carbamide peroxide 6.5% earwax removers (CVS Health, Clinere, TopCare, etc.) for subpotency.
11 products
FDA•MODERATEWY Duck Sauce PacketsW.Y. Industries is recalling 0.35 oz. packets of WY Duck Sauce due to potential metal fragment contamination.