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
Medline is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit, because the silicone seal may dome or tear and occlude the fluid path.
Encore Medical is recalling Reverse Shoulder Prosthesis humeral socket inserts, catalogue number 509-00-432, because knee and humeral socket implants contain incorrect labeling.
Medline is recalling Nail Kit convenience kits, model POD14214, because the manufacturer of the sterile saline wound wash they contain may not have met the required sterility assurance level.
Olympus is recalling its Sheath, 10 Fr, model A37004A, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.
Edermy LLC is recalling the PIE Trolley System, model 2005, because the device lacks 510(k) clearance from the FDA.
Edermy LLC is recalling PIE PAK models P2HC-A, P2HC-S and P2HC because the devices lack 510(k) clearance from the FDA.
Agiliti Health - Ellis is recalling Adapt Pumps (Model 61600200) because the Microclimate Management function may fail to re-engage after using the Autofirm function.
Olympus Corporation of the Americas is recalling 744 Olympus High Flow Insufflation Units (Model UHI-2) because a software algorithm issue may cause overpressure events.
Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.
Medline is recalling 753 units of its tracheostomy convenience kits and trach tote due to potential sterilization equipment calibration issues that may affect the sterility assurance level of the devices.
Medline is recalling 291 units of three burn care convenience kits due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.
Olympus is recalling 9,542 Thunderbeat surgical devices worldwide due to continued reports of adverse events. The recall affects all lots of the TB-0545FCS model.
Wilson-Cook Medical Inc. is recalling 153 Teslatome Bipolar Sphincterotomes due to a potential void in the material separating the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI) because a software algorithm issue may cause overpressure events.
Medline is recalling 4,757 units of convenience surgical kits distributed worldwide due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.
Integra LifeSciences is recalling 2,906 units of its Private Label CVS wound dressings (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier.
Olympus is recalling 1,538 Thunderbeat 5 mm surgical devices worldwide due to continued reports of adverse events. The recall affects all units of Model No. TB-0510IC.
Medline is recalling 12,418 units of various surgical convenience kits due to calibration issues with equipment used for sterilization and packaging, which may affect the sterility assurance level of the devices.
Medline is recalling 448 units of its BASIC NERVE BLOCK TRAY W/LINEN (Model PAIN0150C) due to calibration issues with sterilization and packaging equipment that could affect the sterility assurance level of the devices.
Medline is recalling 14,927,765 units of surgical drapes because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 175 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 72 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 1,070 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.