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 the agency’s own highest classification or reported deaths or serious injuries, 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
GE Healthcare is recalling 110 CARESCAPE Bx50 monitors because they may fail to indicate when pacemaker detection is off, potentially delaying treatment for asystole.
HeartWare Inc is recalling HVAD Pump Driveline Splice Kits because they may fail if exposed to excessive force. The recall affects 35 units distributed in the US and several international countries.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent because increased complaints indicate the product may compromise the hemoglobin chamber in certain blood analysis systems.
The FDA is recalling VenaSeal vascular closure systems because a possible sterility breach in the outer packaging may compromise the device's sterility.
Philips Medical Systems is recalling 918 ADAC Vertex Gamma Cameras because detector heads may drift and contact patients during imaging.
Spacelabs Healthcare is recalling five qube Compact Monitors because the input power can fail or the device may not turn on.
Fujifilm Medical Systems is recalling Synapse Cardiovascular software because measurement values in the EMR may not match clinical reports.
Handicare USA is recalling 64 units of ReTurn patient transfer belts because the heat-welded seam on the strap tore when force was applied.
Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards due to Out-of-Range-Low Flucytosine QC results for Candida krusei.
Siemens Healthcare Diagnostics is recalling certain Dimension Integrated Chemistry Systems installed with non-standard power plugs due to a potential electrical hazard.
Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produce Out-of-Range-Low Flucytosine QC results for Candida krusei. The affected products were distributed to foreign subsidiaries and distributors.
Synthes, Inc. is recalling 8,175 TFNA Proximal Femoral Nails because the locking mechanism was assembled too close to the top, potentially causing surgical delays.
BioHorizons is recalling 48 units of the Tapered HD Upgrade Set because they were packaged with a stainless steel drill instead of the correct titanium component.
Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produced Out-of-Range-Low Flucytosine QC results for Candida krusei.
Philips Medical Systems is recalling 975 nuclear gamma cameras because the collimator exchange carriage and storage cabinet were misaligned.
Fujifilm Medical Systems is recalling Synapse Cardiovascular software versions v4.0.8 and v4.0.8 SR1 because patient demographics in exported reports may not match the clinical reports.
Stryker Howmedica Osteonics is recalling four 80 mm Kinemax Stem Extenders because they were shipped in boxes labeled for the 80 mm part but contained 40 mm extenders.
Zimmer Surgical Inc is recalling 36 units of the 100 mL Hemovac Mini Evacuator because the shipper carton contained only one Instructions for Use (IFU) instead of one per sales unit.
Arc Medical Inc is recalling 1,810 units of ThermoFlo 1 HME because the outer shipping carton displayed an incorrect expiry date, although the inner product carton was labeled correctly.
Spinal Elements, Inc. is recalling 588 Mercury lordosed rods because some lack required product identification markings, interrupting device traceability.
Viewray Incorporated is recalling one ViewRay System due to a software error affecting coordinate correction for non-standard patient positions.
Mitsubishi Heavy Industries is recalling 11 MHI-TM2000 Linear Accelerator Systems due to a software defect that allows radiation delivery despite communication errors and prevents saving treatment records.
Bard Peripheral Vascular Inc is recalling 7,995 Bard MAX-CORE Disposable Core Biopsy Instruments due to a risk of self-activation-related issues.
Spacelabs is recalling Ultraview SL Command Modules with specific Masimo SpO2 components due to a defect causing random resets.
Stryker Instruments is voluntarily recalling Ambulating Bulbs used with wound drains because of a potential sterility breach in the packaging.