Hazard
471 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 471 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 26 (6%) 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 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising the device's sterility.
Vascular Technology, Inc. is recalling 164 Mizuho disposable Doppler probes because the sterile barrier was penetrated, potentially rendering the product unsterile.
Zimmer, Inc. is recalling 852 units of M/L Taper Reduced Neck hip joint prostheses because black residue was observed in the sterile pouches.
Vascular Technology, Inc. is recalling 25 VTI Bayonet Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.
Origio, Inc. is recalling Pasteur Pipets used in IVF laboratories because a breach in the nylon pouch sterile barrier was identified.
Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.
Baxter Corporation is recalling RAPIDFILL Syringe Strips because of a possible breach in the sterile barrier of the inner and outer bags.
Gyrus Medical is recalling 856 units of Disposable Falope-Ring Band Applicator Kits due to a packaging anomaly that may compromise sterility.
Hospira Inc. is recalling 65,109 vials of Bupivacaine Hydrochloride with Epinephrine due to a potential breach in the aseptic process caused by equipment failure.
Smith & Nephew is recalling 46 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Smith & Nephew is recalling 16 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
Stryker Sustainability Solutions is recalling 46 reprocessed diagnostic electrophysiology catheters and cables due to a potential sterility breach in the package seal.
Baxter Healthcare is voluntarily recalling 3,200 units of CLEARLINK Extension Sets due to potential pinholes in the packaging that could breach the sterile barrier.
Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws due to a breach of sterility in the packaging.
Merit Medical Systems is recalling 134 custom angio kits because a missing seal may compromise the sterility of the hand controller sheaths.
Edwards Lifesciences is recalling 379 units of Duraflo coated Femoral Cannula because two unsealed pouches were found at a distribution location, posing a sterility risk.
Medrad Inc is recalling Hand Controller Sheaths because a missing seal may compromise sterility. The product is used in cardiac catheterization procedures.
Ethicon is recalling Surgiflo Hemostatic Matrix kits because a potential cut in the packaging could breach the sterile Tyvek pouch.
Omni Life Science is recalling 36 units of Apex Knee System Modular Tibia Augments because the sterile packaging may breach, compromising sterility.
Omni Life Science is recalling 270 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.
Kimberly-Clark is recalling specific lots of MicroCool surgical gowns because they pill, lint, or allow blood strikethrough, potentially compromising sterility.