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
Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.
Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.
Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units were distributed across six U.S. states and Puerto Rico.
Medical Action Industries is recalling novaplus General Purpose Kit (Cat. No. 56603) containing hemostats that may have flaking metal and brown spots on the instruments.
Smith & Nephew is recalling 5 units of a knee prosthesis component due to surface damage from a manufacturing error. The affected lot was distributed in specific U.S. states.
Exact Medical Manufacturing is recalling 100,600 transducer covers distributed across six states because they lack required FDA 510(k) clearance for use in natural or surgical body openings.
Medical Action Industries recalls General Purpose Instrument Trays due to potential flaking metal and brown spots on hemostats. These defects could contaminate surgical instruments.
Exact Medical Manufacturing is recalling 500 ultrasound transducer covers lacking FDA 510(k) clearance for body cavity use. The affected lot was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
EHOB, Inc. is recalling 70 units of the Econocare Plus Waffle Overlay due to trace amounts of dried bodily fluids that may expose patients and healthcare providers to contaminants.
Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.
Exact Medical Manufacturing is recalling 33,250 ultrasonic transducer probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Certain low-voltage power supplies in Philips Allura Xper interventional X-ray systems may fail, potentially causing loss of imaging functionality. 42 devices are affected worldwide.
Exact Medical Manufacturing recalls 78,000 probe covers that lacked FDA premarket clearance. The product was distributed for use in body openings without required 510(k) approval.
This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.
Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.
The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.
Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.
BioFire Diagnostics is recalling 9 FilmArray Pneumonia Panel test kits due to manufacturing defects causing false positive and negative test results, as well as control failures.
Cardinal Health is recalling Freestyle Lancets due to temperature exposure during shipping that may cause inaccurate results. Affected devices were distributed in Florida, Georgia, and South Carolina.
Exact Medical Manufacturing is recalling 800 units of ultrasound probe covers distributed to six states and Puerto Rico because they lack required FDA 510(k) clearance for use in natural or surgical body openings.
Ventec VOCSN ventilators may unexpectedly shut down or lose blower function during patient use due to component failure. This could prevent the device from providing ventilation therapy. About 1,934 devices are affected.
Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 1,599 boxes of prefilled pen needles that were exposed to low temperatures during shipping, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
BioFire BCID2 panels for FilmArray Systems are recalled due to manufacturing defects causing elevated rates of false negative results. Affected diagnostic kits may fail to detect infections in blood culture samples.
Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.