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
A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.
Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.
An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.
Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures.
Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.
Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.
Philips Azurion 7M20 interventional fluoroscopic X-ray systems with FlexArm ceiling-mounted stands may experience inconsistent or unavailable longitudinal movement due to bearing grease leakage affecting device mobility. Approximately 927 systems worldwide are affected.
Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.
Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.
Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to manufacturing defect that may cause securement flange to tear, compromising tube stability.
Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, risking loss of airway securement.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because of a manufacturing defect that may cause the securement flange to tear.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. Products distributed worldwide.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. The recall affects neonatal, pediatric, and adult versions distributed worldwide.
Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
Smiths Medical is recalling specific lots of Bivona Neonatal and Pediatric Tracheostomy Tubes because the securement flange may tear due to manufacturing defects.
FreeStyle Libre 3 sensors may report falsely high glucose levels, causing users to over-dose insulin and miss dangerous low blood sugar episodes. Abbott has recalled 8,174 units.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.
Smiths Medical is recalling specific lots of PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear, affecting device positioning.
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect in the securement flange, which may tear. Affected patients should discontinue use and contact their healthcare provider.