Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.
Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.
FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.
Medtronic is recalling 4 units of Custom Perfusion Packs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Combat Medical Systems is recalling 954 Fresh Whole Blood Donor Sets due to a potential bent or disconnected needle in the kit components.
Penumbra Inc. is recalling 3,368 JET 7 Reperfusion Catheters because the distal tip may become damaged during use, posing a risk of vessel damage and patient injury or death.
Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.
Boston Scientific is recalling Emblem S-ICD Subcutaneous Electrodes because fractures may prevent the device from delivering therapy.
Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.
Penumbra Inc. is recalling JET 7MAX Kits because catheter tip damage during use could cause vessel damage, leading to patient injury or death.
Cook Inc. is recalling Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.
Smiths Medical is recalling Medfusion Syringe Pump Model 4000 units due to a risk of inaccurate drug delivery following interrupted bolus or loading doses.
CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that may cause over-infusion or under-infusion of therapy.
CME America, LLC is recalling BodyGuard Microset infusion sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.
CME America is recalling BodyGuard BodySet infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.
Heartware, Inc. is recalling HVAD Pump Outflow Grafts because the graft may tear or the strain relief screw may break during pre-implant assembly.
Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.
Boston Scientific is recalling Imager II 5F Angiographic Catheters because the tips may detach. The recall covers 1,068,827 units distributed worldwide.
Philips is recalling HeartStart MRx Monitor/Defibrillators because internal damage from drops or shocks may prevent therapy delivery, even if the device appears undamaged.
CME America is recalling BodyGuard Microset infusion sets because they may under-deliver fluids when used with specific infusion pump systems.
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.
Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.