Hazard
46 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 46 sterility loss recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (22%) 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 loss 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.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal, compromising sterility assurance.
American Regent, Inc. is recalling certain lots of Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects 7,249 cartons distributed nationwide.
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.
Medline Industries is recalling 220 Proxima Drape sterile surgical drapes nationwide due to a potential breach in pouch packaging that could compromise sterility.
Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.
Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert due to potential breaches in the inner and outer sterile packaging. The breaches could compromise device sterility, affecting 132 units in the U.S. and 26 internationally.
Medline Industries is recalling 26,171 kits and trays containing potentially non-sterile irrigation solutions and syringes supplied by Nurse Assist, which could pose risks if used in medical procedures.
Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.
Central Admixture Pharmacy Services is recalling heparin injectable solutions nationwide due to sterility concerns identified during an FDA inspection. Over 11,000 bags of the product are affected.
Medline Industries recalls multiple sterile arthroscopy surgical trays because blades in the kits may puncture the outer foil packaging, potentially compromising sterility. Affected products were distributed worldwide.
Beaver Visitec is recalling its surgical eye knife (Part 376630) used in cataract procedures due to compromised sterile packaging that may lead to infection. Approximately 599 units have been affected in the US.
Stradis Healthcare is recalling Endo Pack surgical trays (Item 682-509) because manufacturing defects may result in incompletely sealed outer bags, potentially compromising kit sterility. Products were distributed in the US and Canada.
Radiometer Medical is recalling Arterial Blood Samplers (REF:956-552) because sterility cannot be guaranteed throughout the product's shelf life. The recall affects 7,228 boxes distributed worldwide.
Medtronic is recalling IN.PACT AV paclitaxel-coated balloon catheters because packaging damage may result in loss of sterility. The devices were distributed worldwide and in the United States.
Corin Ltd is recalling specific Trinity Dual Mobility hip implant components due to packaging damage that may compromise sterility. The affected products were distributed to medical facilities in nine states.
Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during July 2021.
Corin Ltd is recalling Corin BIOLOX Delta Mod Head hip implant components due to packaging system damage that could result in loss of sterility or device contamination. Affected units were distributed nationwide to nine states.
Corin Ltd recalls two models of Unity Knee CS Insert implant components due to potential packaging damage that could compromise sterility or cause contamination. Affected devices were distributed in nine U.S. states in July 2021.
Corin Ltd is recalling Corin Trinity-i acetabular components (50mm diameter, Taper Size 3) distributed nationwide due to potential physical and water damage to the packaging system, which may compromise device sterility or cause contamination.
Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.
Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.
Corin is recalling Corin Unity Knee Patella components due to potential packaging damage that could compromise sterility and device integrity. Affected units were distributed in nine US states in July 2021.
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 100 mcg/mL (Lot #31327466B, expiring 08/2021) nationwide due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.