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
Devicor Medical Products is recalling 90 HydroMARK Breast Biopsy Markers due to mismatched patient labels that incorrectly identify the product model. The small patient label identifies the device as model 4010-05-08-T3, while the correct model is 4010-05-08-T4.
Teleflex Medical is recalling Gibeck brand respiratory filters due to reports of torn corrugated breathing tubes. No injuries have been reported.
Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.
Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges because the product was not approved for release for US distribution.
Steris Corporation is recalling 103 cases of Ultra Pure Non-Woven Sponges (Lot 202108) distributed nationwide because the product was released without FDA approval. Customers should discontinue use and contact the manufacturer.
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.
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 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.
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.
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.
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.
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.
Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.
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.
Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.
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.
Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.
HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.
Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.
Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.
Baxter Healthcare is recalling 1,414 Voalte Nurse Call System units distributed to North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.