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.
Medline is recalling approximately 9,608 automatic digital blood pressure units due to a faulty microchip that causes power failures, display issues, and overheating.
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.
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.
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.
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.
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.
The FDA is recalling the Triathlon Universal TS Baseplate Size 2 knee implant due to defective locking tabs that may not properly engage with the tibial insert, potentially causing implant failure.
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.
Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.
Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.
Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.
Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.
The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.
Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.
Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.
FDA recall of 152 Inspire Model 4340 Respiratory Sensing Lead units due to a labeling error—the serial number printed on the product box does not match the actual serial number of the device inside.
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.
Medtronic MiniMed 630G and 700G insulin pumps may experience battery depletion and device shutdown after physical impact, interrupting insulin delivery in diabetic patients.
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.
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.
MiniMed insulin pumps are recalled because physical impact can damage internal components, reduce battery life, and cause unexpected device shutdown that interrupts insulin delivery.
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.
Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.
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.