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
Maquet Cardiovascular is voluntarily recalling Rotaflow Centrifugal Pump custom tubing packs due to a potential risk of endotoxin exposure.
Customed, Inc. is recalling 380 units of Foley Catheter Trays in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 258 Premium Laparotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 120 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 30 units of PERI-GYN Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 72 Cysto TUR Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because the company could not validate the sterilization process or package integrity.
Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using certain instruments with ablation probes can increase microscopic metallic particulates.
Customed, Inc. is recalling 55 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 16 units of Femoral Angiography Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 40 umbilical vessel catheter kits distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Philips Medical Systems is recalling 82 Ingenuity CT systems due to a software error that may prevent the automatic transmission of image data to remote devices.
ICU Medical is recalling 57 Diana Automated Compounding Systems because they may not accurately mix volumes under 5ml.
X-NAV Technologies is recalling 845 X-Guide Surgical Navigation System X-Clip Bulk Kits because the stainless steel fiducials may not meet specifications.
Stryker is recalling 286 SurgiCounter scanners because they may display error messages and fail to display software version numbers correctly in the SC360 application.
C.R. Bard is recalling 1.4 million Bardex Foley catheters because the instructions for use list an incorrect inflation volume.
Boston Scientific is voluntarily recalling PT Graphix Magnet J-TIP Guidewires because the wires are straight instead of having the pre-formed J-tip.
Merit Medical Systems is recalling one lot of TSX Transseptal Needles because the packaging labels incorrectly state a 50-degree curve instead of the actual 86-degree curve.
Alcon is voluntarily recalling 97 VERION Reference Units because unplanned arcuate lines may appear on printed or exported surgical plans.
Stryker is recalling 140 Spetzler Claw Tips because they were packaged with the incorrect size Tip Sleeve Assembly, which may cause surgical delays.
Philips is recalling 174 Ingenuity Core 128 CT systems due to a software error that may prevent automatic transmission of image data to remote devices.
Philips Medical Systems is recalling 285 Brilliance 64 CT systems because a software error may prevent the automatic transmission of all image and data series to remote devices.
Cygnus Medical is recalling First Step Bedside ADDWATER Kits due to foreign material found in the containers. The recall affects 39 cases distributed to 13 US states.
ICU Medical is recalling 36 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.
Philips is recalling 49 Brilliance iCT SP CT systems due to a software error that may prevent automatic transmission of image data to remote devices.