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
Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices due to potential holes in the sterile barrier pouches.
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are sterile, single-use diagnostic tools used for drawing arterial blood.
Smith & Nephew is recalling RENASYS-G Sterile Gauze Dressing Kits due to inadequate Soft Port sealing that may prevent fluid evacuation and fail to trigger alarms.
Smith & Nephew is recalling RENASYS-AB Abdominal Dressing Kits because inadequate sealing may prevent fluid evacuation and fail to trigger pump alarms.
Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Smith & Nephew is recalling RENASYS Soft Port Dressing Kits because inadequate sealing may prevent wound fluid evacuation and fail to trigger pump alarms.
Horiba Medical is recalling ABX PENTRA ML software because a bug may transmit incorrect results to Laboratory Information Systems.
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are used for in-vitro diagnostic blood sampling.
Boston Scientific is recalling seven RunWay Guide Catheters because their sterile pouches may not be completely sealed, potentially compromising sterility.
Smith & Nephew is recalling RENASYS Gauze with Soft Port Kits because inadequate sealing can cause fluid to remain under the dressing and prevent the pump alarm from activating.
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.
Philips is recalling HeartStart MRx Monitor/Defibrillators with the Q-CPR Meter option because the device may incorrectly display a 'Do Not Touch the Patient' icon during defibrillation mode.
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.
Synthes, Inc. is recalling Small Notch Titanium Reconstructive Plate sets distributed for spine applications where they are contraindicated.
GE Healthcare is recalling CARESCAPE Monitor B650 and B850 units due to potential safety issues with Non-Invasive Blood Pressure and Bed to Bed functions.
Smiths Medical ASD, Inc. is recalling specific Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use, and used for drawing arterial blood.
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.
BioMerieux is recalling 471 PREVI Isola Systems because they may fail to dispense urine samples, potentially leading to false negative growth results.
GE Healthcare is recalling 3,062 Elscint APEX Helix gamma cameras due to a potential safety issue where the detector may drift toward the patient.
Smith & Nephew is recalling RENASYS-F Foam Dressing Kits with Soft Port due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use, in-vitro diagnostic tools used for drawing arterial blood.
Accumetrics is recalling VerifyNow IIb/IIIa test kits because they may report erroneous low platelet aggregation unit results, potentially affecting clinical decisions.
Elekta is recalling the XiO RPT System because dose and monitor unit values are not computed correctly when specific wedges are used with dynamic arcs.