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
Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges because the product was not approved for release for US distribution.
Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.
Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.
Avanos Medical is modifying labeling for the Cortrak 2 Enteral Access System and discontinuing the Anonymous Account Mode feature. Users must confirm tube placement per institutional protocol.
Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.
Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.
HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.
Beckman Coulter is recalling four MicroScan WalkAway-96 Plus systems that may have been assembled with a power connector rated at 1 ampere instead of the correct 10 amperes, creating an electrical hazard risk.
Boston Scientific issued updated instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation and provide best practices for safe insertion, advancement, and removal.
Boston Scientific's EXALT Model D duodenoscope is subject to updated use instructions addressing a known risk of perforation. The FDA requires updated guidance on insertion and removal procedures.
Radiometer Medical is recalling Arterial Blood Samplers (REF:956-552) because sterility cannot be guaranteed throughout the product's shelf life. The recall affects 7,228 boxes distributed worldwide.
The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.
Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety risk.
Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) in Finland and Turkey due to translation errors in device displays and supporting documentation that could impair proper device operation.
CooperSurgical is recalling 2,340 VitriGuard cryopreservation devices with compromised barrier seals that may compromise sterility. The affected devices were distributed across ten U.S. states.
Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.
Luminex Corporation is recalling 24 Verigene Processor SP units because the heater may operate outside established temperature limits, potentially producing false negative diagnostic results.
Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.
Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.
Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.
Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.
Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.
Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set because Template Ultra Quick matrix Material was packaged instead of the indicated Heavy Body viscosity. The recall affects 46 units distributed in South Carolina.
The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.