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
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.
CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.
ZOLL Circulation is recalling 98 units of SOLEX 7 intravascular heat exchange catheter kits due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued to address the safety concern.
Exactech is recalling 8,985 OPTETRAK Comprehensive Knee System inserts due to insufficient oxygen barrier protection in vacuum packaging. The packaging deficiency was identified as the basis for the recall.
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.
ZOLL Circulation is recalling 33,066 units of the Zoll REF 8700-0782-40 ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing.
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 recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to potential leaks from the catheter or start-up kit tubing.
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.
Innovative Orthopedic Technologies is recalling the ARCH Leg Positioning System due to manufacturing defects that prevent locking pins from properly engaging under load.
ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.
Welch Allyn Inc Mortara is recalling ELI 280 Resting Electrocardiographs due to device malfunction under specific operator workflows. The recall affects 14,630 units distributed nationwide and internationally.
ZOLL Circulation is recalling COOL LINE intravascular heat exchange catheters due to potential leaks in the catheter or start-up kit tubing that could affect their function during medical procedures.
Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.
ZOLL Circulation is updating product labeling for Quattro IVTM disposable packs and start-up kits due to potential leaks from catheter or tubing components. Distribution includes US nationwide and international markets.
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.
ZOLL Circulation is recalling 13,935 QUATTRO Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or start-up kit tubing. The affected devices were distributed worldwide, including across all US states.
Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.
ZOLL Circulation is recalling 4,812 COOL LINE Intravascular Heat Exchange Catheter Kits worldwide due to potential leaks in the catheter or startup kit tubing.
ZOLL is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (188 units) addressing potential leaks from the catheter or start-up kit tubing.
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.
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.
ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.
Exactech is recalling 31,201 TRULIANT Knee System tibial inserts whose packaging lacks an oxygen barrier layer. The implants were 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.