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.
Axium Healthcare Pharmacy is recalling Quadmix Custom Injectable vials due to lack of sterility assurance and quality control concerns.
Hospira is recalling 11,412 bags of HEXTEND (Hetastarch) 6% Injection due to a potential leak from the fill tube seal that compromises sterility.
Cordis is recalling ExoSeal Vascular Closure Devices because the sterilization process did not meet required sterility assurance levels.
New England Compounding Center is recalling Bupivacaine 0.25%, 0.5%, and 0.75% PF products because the agency cannot assure the sterility of the medication.
New England Compounding Center is recalling Hyaluronidase 150 u/ml PF vials nationwide because the FDA determined there is a lack of assurance of sterility.
New England Compounding Center is recalling Dexamethasone Sodium Phosphate vials due to a lack of assurance of sterility.
Ameridose LLC is recalling all sterile products manufactured in Westborough, MA, due to a lack of assurance of sterility. The recall is nationwide and includes all lot codes within expiry.
Merit Medical Systems is recalling Cytosol Ophthalmics Balanced Salt Solution kits due to a lack of assurance of sterility and potential endotoxin contamination.
Kimberly-Clark is recalling specific lots of MicroCool sterile surgical gowns because package seams may not be properly sealed, potentially compromising sterility.
Carefusion 213, LLC is recalling ChloraPrep One-Step skin preparation applicators because quarantined material failed sterility testing. The affected product was distributed in Illinois, Missouri, and New Jersey.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.
Unimed Surgical Products is recalling Medline Extended PTFE Needles due to sterility concerns. The recall affects 1,440 units distributed nationwide.
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units were distributed nationwide in the US.
Franck's Lab Inc. is recalling sterile Doxorubicin HCL vials because FDA sampling found microorganisms and fungal growth in the clean room where the drugs were prepared.
Franck's Lab Inc. is recalling Cisplatin 1mg/ml injectable products because FDA sampling found microorganisms in the clean room where they were prepared.
Franck's Lab Inc. is recalling Taurine 50mg/mL Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile bupivacaine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling sterile cyanocobalamin (Vitamin B12) injectables because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.
Franck's Lab Inc. is recalling sterile midazolam injectables distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.