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
ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.
ZOLL is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or tubing. An FDA labeling update has been issued to address this risk.
Contamac Solutions is recalling Nutrifill Scleral, Hybrid, and GP Lens Insertion Solution nationwide due to potential foreign material contamination. The solution is used to insert contact lenses and was distributed to all U.S. states and Washington, DC.
ZOLL Circulation Inc. is recalling its Cool Line IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing that may affect medication delivery.
ZOLL Circulation is issuing a labeling update for its Premium Access Kit QUATTRO intravascular catheter kits due to potential leaks in the catheter or start-up kit tubing. This affects 1,253 kits distributed worldwide.
Exactech is recalling ARTHROFOCUS Polyethylene Tibial Inserts due to packaging defects. Inserts lacked an oxygen barrier layer in their vacuum bag packaging, which could compromise device integrity.
ZOLL is recalling its Quattro IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing. The recall affects 579 bundled kits distributed worldwide.
Johnson & Johnson is recalling TECNIS Eyhance intraocular lenses due to elevated endotoxin levels exceeding internal and FDA specification limits. Affected lenses were distributed nationwide in Illinois.
Certain Philips Sparq ultrasound systems may experience intermittent shutdowns due to a battery system data issue, potentially interrupting diagnostic procedures. Affected units have specific serial numbers and distribution includes multiple U.S. states.
Exactech is recalling 31,201 TRULIANT Knee System tibial inserts whose packaging lacks an oxygen barrier layer. The implants were distributed worldwide.
Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.
Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.
ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.
ZOLL Circulation is recalling 3,425 units of the ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued.
Nox T3s Recorder sleep monitoring devices are being recalled due to a firmware error that causes inaccurate detection of device position, which may affect diagnostic accuracy.
FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.
Paltop Advanced Dental Solutions is recalling 337 Scan Abutment MU devices due to manufacturing tolerance deviations in orientation and sizing that may delay dental restoration procedures.
ZOLL Circulation is recalling approximately 1,122 ICY Heparin infusion kits distributed worldwide due to potential leaks in the catheter or start-up kit tubing. No illnesses or injuries have been reported.
GE Healthcare's Centricity Universal Viewer has a software defect where changes to radiological studies are not saved to archive systems, potentially affecting clinician access to current image data.
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump devices because the helium indicator on the display may overestimate helium levels when electromagnetic interference is present.
ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles distributed worldwide.
Bard Peripheral Vascular is recalling REF TIN3015 bone marrow aspiration needles because the needle protector can become fully dislodged, exposing the needle and creating needle-stick injury risk for healthcare workers.
ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.
Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.
ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.