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
BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.
Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.
The cobas EGFR Mutation Test v2 may produce false positive results for exon 20 insertion mutations, potentially leading to inappropriate treatment. Healthcare providers should verify detected mutations using alternative methods.
Smiths Medical ASD Inc. is recalling 870 units of LogiCal blood sampling sets distributed across Europe and Saudi Arabia due to reported pressure shifts and incorrect pressure readings.
Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.
K2M, Inc. is recalling 23 units of the Chesapeake Anterior Lumbar Removal Tool because units may arrive with missing pins or in disassembled condition. Pins could dislodge during surgery and enter the surgical cavity, requiring intraoperative removal or revision surgery.
Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.
Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.
Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA has issued a Class I recall affecting 8,702 units distributed worldwide.
Ultrasound gel manufactured by Eco-Med Pharmaceutical and distributed with various medical device kits may contain bacterial contamination. Users should stop using affected products and follow FDA guidance.
Eco-Med Pharmaceutical's ultrasound gels and lotions are recalled for potential bacterial contamination. The FDA advises health care providers to stop using all affected products.
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.
ZOLL Circulation is addressing potential leaks in Quattro IV Disposable Packs and Start-Up Kits through a labeling update affecting 334 bundles distributed worldwide.
Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.
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.
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.
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.
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.
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.
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.
CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.
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 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.