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
ICU Medical is recalling the ASM Replacement Battery due to a manufacturing defect from the battery supplier. The defect may cause batteries to lose capacity and experience decreased runtime earlier than expected.
Draeger Medical is recalling the VentStar Watertrap (N) 180 due to glued breathing circuit connections that may become loose or detach during ventilation, posing patient safety risk.
ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.
Glued connections on the VentStar Watertrap breathing circuit can become loose or detach during ventilation, potentially interrupting airflow. Draeger Medical is recalling all affected units nationwide.
Draeger Medical is recalling 325 VentStar Basic (P)180 ventilators because glued breathing circuit connections can become loose before or during ventilation, potentially causing partial or complete detachment of circuit pieces.
Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.
Draeger Medical is recalling Anesthesia Circuit Kit Coax 1 (MP02730) because glued breathing circuit connections can become loose or detach during ventilation, affecting the breathing circuit's function.
Draeger Medical is recalling VentStar Coax (P) 150 breathing circuit components due to potentially loose glued connections that could detach during ventilation, affecting 280 units distributed nationwide.
ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.
Draeger Medical is recalling ID Circuit Basic breathing circuits due to glued connections that can loosen during ventilation, potentially causing partial or complete detachment of circuit pieces.
Draeger Medical is recalling 1,725 VentStar Basic ventilators because glued breathing circuit connections can become loose and detach before or during ventilation. This may disrupt patient breathing support.
Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.
Draeger Medical is recalling Anesthesia Circuit Kit Coax 3 units because glued connections can become loose or detach before or during ventilation. The recall covers 329,294 units distributed nationwide.
Draeger Medical is recalling 130 units of the VentStar Anesthesia WT ventilator due to a defect where glued breathing circuit connections may loosen or detach during ventilation, potentially compromising anesthesia delivery.
Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.
Surgical Innovations Ltd is recalling 2380 YelloPort Elite optical trocars due to inability to guarantee sterility. Patients using contaminated surgical instruments may develop serious infections.
IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.
Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.
240 units of HydroPICC 4Fr Single Lumen Catheter Maximal Barrier Kits are being recalled because the catheter's actual expiration date is shorter than the date printed on the outer package.
The Philips Incisive CT system's foot switch may trap the operator's foot during the unload function, causing injury. The FDA has issued a Class II recall affecting 46 units worldwide.
Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.
Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.
Stryker Sustainability Solutions recalls reprocessed DVT compression sleeves that may be mislabeled or mispackaged. These prescription-only devices could be improperly identified or distributed due to packaging errors.
Beckman Coulter's iQ200 Series urine analyzers may fail to display a flag indicating prior samples, potentially preventing detection of sample contamination from carryover events.
Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.