Hazard
2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging adhered to internal sterile packaging, potentially compromising sterility.
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.
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 4,757 units of convenience surgical kits distributed worldwide due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.
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 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.
Alcon Research is recalling 151 Custom Pak ophthalmic procedure packs because the packs may have incomplete seals affecting sterility. The FDA has classified the action as Class I.
AVID Medical is recalling 90 Halyard Major Packs over the potential for an incomplete seal on the header bag.
AVID Medical is recalling 240 Halyard EP Lab packs over the potential for an incomplete seal on the header bag.
Medline is recalling 53 sterile Kelly forceps because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.
AVID Medical is recalling 42 Halyard General Laparoscopy Packs over the potential for an incomplete seal on the header bag.
AVID Medical is recalling 56 Halyard Head and Neck Trays over the potential for an incomplete seal on the header bag.
Medline is recalling 56 sterile operating room scissors because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.
AVID Medical is recalling 300 Halyard Midtown General Arteriogram trays over the potential for an incomplete seal on the header bag.
Medline is recalling 11,291,800 Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 18,000 units of Curad Quick Strip Fabric Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 1,566,500 Fur Friends Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 4,381,400 Quick Strip Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 1,725,600 Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 6,989,900 Quick Strip Fabric Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 182,526 CURAD Germ-Shield Touch-Free Fabric Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Halyard ENT Packs, model JACK421-04, lot 1647218, are recalled because of the potential for open header bag seals, compromising sterility. 57 units are affected.
Halyard CPT Basic IR Packs, model 1646381, are recalled because of the potential for open header bag seals, compromising sterility. 228 units are affected.