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
Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.
Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Bios S.r.l. is recalling 167 THERMI250 Radiofrequency Systems because they may continue to emit RF energy after the PAUSE button is pressed.
Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.
Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Smiths Medical is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.
Smiths Medical is recalling CADD Medication Cassette Reservoirs that may have been manufactured with an incorrect pressure plate. The recall covers units distributed worldwide.
Alcon Research is recalling Alcon Custom Paks because a supplier recalled x-ray detectable sponges used in the product.
OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.
MicroPort Orthopedics is recalling 48 sterile Schanz screws due to an inadequate pouch seal that could compromise sterility and lead to infection.
FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.
Bard Peripheral Vascular Inc is recalling 110,550 Max-Core Disposable Core Biopsy Instruments due to increased complaints of failure to prime, fire, or obtain samples.
Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software because incorrect source step sizes may occur in treatment plans.
W.L. Gore & Associates is recalling 12,197 GORE TAG Thoracic Endoprosthesis units worldwide due to a risk of incomplete or partial deployment during endovascular procedures.
Beckman Coulter is recalling 27 Power Processor 1K Stockyard units because a software error may cause sample tubes to be retrieved during rack loading.
Sysmex America is recalling Fluorocell PLT reagent lots because they may produce falsely low platelet results, potentially affecting diagnostic accuracy.
Encore Medical is recalling 46 EMPOWR PS Knee Inserts because one unit was packaged with the wrong implant. The recall covers US nationwide distribution.
Encore Medical is recalling 48 units of EMPOWR PS Knee inserts because one unit was packaged with the wrong implant reference number.
Siemens Medical Solutions is recalling 16 torque wrenches used to install Symbia CT scanners because the tools were found to be out of tolerance.
St. Jude Medical is recalling 1,744 Proclaim DRG Implantable Pulse Generators because the battery indicator status may be inaccurate.
St. Jude Medical is recalling 3,119 Infinity 5 and 7 Implantable Pulse Generators because battery longevity estimations may be inaccurate.
St Jude Medical is recalling 164,366 Assurity MRI pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
Genesys Orthopedics is recalling 120 Binary Screwdrivers because the threaded inner shaft tip can break off during cervical screw insertion.