Hazard
462 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 462 sterility breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (5%) 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 breach 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.
Smith & Nephew is recalling TwinFix Ti 2.8 mm HS Suture Anchors because a protective tube failure may have breached the sterile barrier.
Ethicon Endo-Surgery Inc is recalling Ligamax 5 mm Endoscopic Multiple Clip Appliers due to potential holes in the Tyvek lidding that could breach sterility.
Shippert Medical Technologies is recalling Tissu-Trans FILTRON 100 sterile pouches because a cut or hole may compromise the product's sterility.
Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.
ConvaTec is recalling Nelaton Urinary Catheters because an internal assessment found a potential breach in the sterile barrier, which could compromise the device's sterility.
Intuitive Surgical is recalling da Vinci Harmonic ACE Curved Shears because sterile packaging may be damaged during transit, potentially compromising sterility.
Atrium Medical Corporation is recalling 2,930 units of 28Fr PVC Thoracic Catheters due to a seal defect in sterile barrier pouches that could compromise sterility.
Ecolab is recalling specific lots of Camera Arm Drapes because wrinkles in the packaging seal could compromise the product's sterility.
Ecolab is recalling specific lots of Disposable Accessory Kits for the Da Vinci Si Robotic system because wrinkles in the packaging seal could compromise sterility.
Ecolab Inc is recalling specific lots of Disposable Accessory Kits, 3-Arm, due to potential pouch seal defects that could compromise sterility.
Ecolab is recalling specific lots of sterile instrument arm drapes for the Da Vinci Si system because seal wrinkles may compromise sterility.
Zimmer Biomet is recalling 32 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Zimmer Biomet is recalling 60 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Zimmer Biomet is recalling 25 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Zimmer Biomet is recalling 18 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
COVIDIEN LLC is recalling Kerlix Bandage Rolls due to a seal defect that may compromise sterility. The recall covers 2,730,821 units distributed nationwide.
COVIDIEN LLC is recalling Kerlix Bandage Rolls due to a potential seal defect that could compromise product sterility.
Coviden LLC is recalling Kerlix AMD Antimicrobial Bandage Rolls due to a potential seal defect that could compromise product sterility.
COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls due to a potential seal defect that could compromise sterility.
COVIDIEN LLC is recalling Kerlix Gauze Rolls due to a potential seal defect that could compromise sterility.
COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls due to a potential seal defect that could compromise product sterility.
Medline is recalling 3,000 Art-Line Surgery Packs because a non-sterile CHG disk was attached to the outside of the sterile packaging, posing a potential infection risk.
Pharmalucence, Inc. is recalling 95 kits of Technetium TC 99M Medronate due to a reported breach of sterility. The affected product is distributed nationwide.