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.
Henry Shein CYSTO SET UP PACK units are being recalled due to potential pinhole leaks in the outer bag that could compromise the sterility of the kit.
Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.
STRADIS HEALTHCARE WECKCELL EYE SPEARS surgical kits (Item 9430, 9431) are recalled due to incomplete outer bag sealing that may compromise kit sterility. Approximately 80 kits distributed in the US and Canada are affected.
Owens & Minor Distribution recalls Aero Blue Performance Surgical Gowns due to potential open seal pouches that could compromise sterility and result in non-sterile products being used in surgery.
Corin Ltd is recalling the Unity Total Knee System due to potential damage to internal packaging that could compromise device sterility. No injuries have been reported.
ICU Medical is recalling 137,120 bags of 0.9% Sodium Chloride Injection because bags may leak and potentially compromise sterility. The affected lot (5829936) was distributed nationwide.
Medline recalls Bausch + Lomb Eye surgical kits due to breather pouches with openings in the seal. Affected kits were distributed to healthcare facilities nationwide; unopened kits should not be used.
Medline is recalling 240 Radiology Procedure Packs because some breather pouches show seal openings that could compromise sterility. The affected kits were distributed nationwide.
Medline is recalling 96 sterile surgical kits (REF DYNJ50099C, Lot 22DBL482) distributed nationwide due to complaints of openings in breather pouches that compromise sterility and increase contamination risk.
Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.
Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.
Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.
Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires due to potential packaging seal breaches that may compromise device sterility. Affected devices were distributed in the United States and internationally.
Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.
Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide and internationally.
Cook Incorporated is recalling Cope Mandril Wire Guide (Nitinol) devices because the packaging's chevron seal may be completely breached, potentially compromising sterility. The recall affects 1,501 US units and 380 international units.
Collagen Matrix Inc is recalling Collagen Dental Wound Dressing products because packaging may not be sealed, potentially compromising sterility. Affected products were distributed to medical distributors in six states.
Cook Incorporated is recalling Bentson Wire Guide guidewires due to packaging seal failures that may compromise sterility. The recall affects over 5,500 units distributed in the U.S. and internationally.
Cook Incorporated is recalling Bentson Plus Wire Guides due to potential packaging seal breaches that may compromise device sterility. Affected devices may not maintain proper sterility before use.
Cook Incorporated is recalling specific lots of Movable Core Wire Guide guidewires due to a potential breach of the packaging seal that may compromise device sterility.
Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically and worldwide.
Cook Incorporated is recalling Fixed Core Wire Guide devices due to a potential breach in the packaging seal that may compromise device sterility.
Cook Incorporated is recalling Fixed Core Wire Guide products due to potential breach of sterile packaging seals. Affected devices may have compromised sterility.