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
Auris Health is recalling Monarch Platform (Urology) devices due to strain relief defects in power cords that may cause electrical short and potential shock to operating room staff.
The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.
Cook Incorporated is recalling Check-Flo Performer Introducer Sets due to white caps that may disconnect from the shaft-hub connection. Affected units were distributed to Australia.
Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.
3M is recalling Tegaderm CHG I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter. The affected lot (33WWRRR) was distributed to South Korea.
Enterprise Imaging XERO Viewer incorrectly displays reference lines on medical images due to a software defect affecting images with non-square pixel spacing. The misplaced reference lines may lead to diagnostic errors.
MEDLINE is recalling 7,428 Automatic Digital Blood Pressure Monitors due to a faulty microchip causing power-on failures, display issues, and overheating. Units were distributed in the US, Panama, and Jamaica.
Quantum Surgical recalls 2 units of the EPIONE device v1.0.2 because rust has developed on the central axis component of the Needle Guide product. These units were distributed in Florida.
The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.
BD Synapsys Informatics Solution versions 4.20–5.30 contain a software error that may incorrectly display antibiotic susceptibility results, potentially leading to inadequate or prolonged antibiotic treatment.
Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.
Philips patient monitors with Option CP2 software version P.01.01 were factory-configured incorrectly, leaving enhanced arrhythmia detection alarms disabled. Affected devices will not trigger yellow alarms for enhanced arrhythmia detection.
Beckman Coulter DxI 9000 immunoassay analyzers with software version 1.16.2 and prior can process orders using expired calibration material, potentially producing incorrect patient laboratory test results.
Medtronic MiniMed insulin pumps (670G, 770G, 780G) that have been dropped or bumped may develop internal battery defects causing premature failure and interrupted insulin delivery, risking dangerously high blood sugar.
MiniMed insulin pumps are recalled because physical impact can damage internal components, reduce battery life, and cause unexpected device shutdown that interrupts insulin delivery.
Percussionaire Corporation recalled 2523 IPV therapy in-line valves due to insufficient labeling regarding cap removal prior to use. Updated labeling ensures patients and healthcare providers understand proper device preparation.
Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators due to a manufacturing defect that may cause the circuit flow controller to come apart, potentially compromising emergency respiratory support.
Medtronic MiniMed 630G and 700G insulin pumps may experience battery depletion and device shutdown after physical impact, interrupting insulin delivery in diabetic patients.
Percussionaire is recalling the P5-TEE IPV in-line valve to update labeling and ensure the blue cap is removed before use and delivery of the device.
Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.
Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.
Young Dental Manufacturing is recalling BIOTROL PURIT Clean-It Ultrasonic Cleaner (REF PC016) due to bacterial contamination in the bulk product used for repackaging. The recall affects 1,391 units distributed across 10 states.
Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.
CooperVision is recalling 607 BIOFINITY XR TORIC soft contact lenses due to a manufacturing defect with misaligned axis, resulting in incorrect power and poor visual acuity. The lenses were distributed in the US and Canada.
DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.