Hazard
1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.
BRS Analytical Services is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4% eye drops nationwide due to cGMP deviations and lack of assurance of sterility.
Apollo Care, LLC is recalling FentaNYL 500mcg/2mcg/mL and Ropivacaine HCl 250mg/0.1% epidural injection due to lack of assurance of sterility. The recall affects 440 bags of a single lot distributed in Missouri.
BRS Analytical Services is recalling Lubricant Eye Drops Solution (Polyethylene Glycol 400 and Propylene Glycol) due to manufacturing deviations and lack of assurance of sterility. The product was distributed nationwide.
Leiters Health is recalling dexmedetomidine HCl PF syringes nationwide due to leaking or damaged syringes that may not maintain sterility. Affected lot 2431276A has an expiration date of 4/20/2025.
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 220135) due to lack of sterility assurance. The recall affects 9,020 units distributed nationwide and internationally.
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 227-5) due to lack of sterility assurance. The recall affects 1,040 units distributed nationwide and internationally.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection due to lack of assurance of sterility resulting from bacterial contamination detected during media fill testing. The recall affects 23,960 vials distributed nationwide.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection 50mg/mL vials nationwide due to lack of assurance of sterility from bacterial contamination detected in media fill testing.
American Contract Systems, Inc. is recalling 800 units of Cysto Pack procedure trays (Model BHCY31E) distributed in Arizona due to sterility assurance concerns.
American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.
American Contract Systems recalls 460 Cardiac Cath Lab Pack kits due to sterility assurance issues with procedure trays. Facilities should verify affected lots have been removed from clinical use.
Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.
Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.
Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.
Cardinal Health is recalling Presource fetal surgery kits due to potential endotoxin contamination in non-sterile surgical strips and patties, which could pose infection risk.
Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.
Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.
27,560 bevacizumab injection syringes distributed nationwide are being recalled due to failure to maintain sterility assurance. The affected syringes may not be sterile.
Medline recalls 626,305 Clean Catch Kits whose specimen containers are non-sterile despite sterile labeling, risking specimen contamination and unnecessary treatment.
FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.
Regeneron is recalling 405,725 prefilled syringes of EYLEA (aflibercept) eye injection due to lack of assurance of sterility and complaints of syringe breakage. This FDA Class II recall affects multiple lots distributed nationwide.
Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.
Imprimis NJOF, LLC recalls Moxifloxacin intraocular injection vials nationwide due to lack of sterility assurance. The 18,980 affected vials (lot 23OCT013) should not be used.
Imprimis NJOF, LLC is recalling preservative-free intraocular injection vials of Dexamethasone-Moxifloxacin due to lack of assurance of sterility. Approximately 39,700 vials were distributed nationwide.
Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.