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.
Rohto Digi-Eye cooling eye drops are recalled due to a lack of assurance of sterility. The recall affects 65,219 cartons distributed nationwide in the U.S.
The FDA is recalling ROHTO DRY-AID cooling eye drops due to lack of assurance of sterility. The product was distributed nationwide in the United States.
Argon Medical Devices is recalling Bone Marrow Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria.
Argon Medical Devices is recalling an Arterial Line Kit containing Lidocaine HCL Injection USP because the kits do not meet sterility release criteria, creating a risk of infection from non-sterile medical injection.
Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.
Argon Medical Devices is recalling General Biopsy Tray kits containing Lidocaine HCL Injection because the kits do not meet sterility release criteria.
Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits containing Lidocaine HCL Injection USP 1% because the kits did not meet sterility release criteria.
Argon Medical Devices is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F because kits containing Lidocaine HCL Injection USP did not meet sterility release criteria.
Bortezomib for Injection 3.5mg/Vial manufactured by Reliance Life Sciences is being recalled nationwide due to lack of sterility assurance. Affected lots include RBIH0125A, RBIH0225A, RBIH0325A, and RBIH0525A distributed across the USA.
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from bag perforations that could compromise sterility. Affected patients should contact their healthcare provider immediately.
CareFusion 213, LLC is recalling PurPrep sterile topical solution due to lack of assurance of sterility and potential product contamination. The affected product is a povidone-iodine and isopropyl alcohol solution distributed nationwide.
Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops because the manufacturer cannot guarantee the product remains sterile. Affected lots are 1X68 and 1X69, with an expiration date of 05/31/2027.
Leader Artificial Tears 15 mL, containing polyvinyl alcohol and povidone, are being recalled for lack of assurance of sterility.
Quality Choice Moisturizing Relief Eye Drops, containing dextran 70, polyethylene glycol 400, povidone and tetrahydrozoline hydrochloride, are being recalled for lack of assurance of sterility.
GoodSense Eye Drops Original Formula, containing tetrahydrozoline hydrochloride, are being recalled for lack of assurance of sterility.
GNP Eye Drops Redness and Dry Eye Relief, containing glycerin and naphazoline hydrochloride, are being recalled for lack of assurance of sterility.
K.C. Pharmaceuticals is recalling Sterile Eye Drops Soothing Tears, sold as Rugby Lubricating Eye Drops and Walgreens Lubricant Eye Drops, for lack of assurance of sterility.
Leader Ultra Lubricating Eye Drops, containing polyethylene glycol 400 and propylene glycol, are being recalled for lack of assurance of sterility.
Artificial Tears containing glycerin are being recalled for lack of assurance of sterility. About 1,023,096 bottles were distributed nationwide.
Teva is recalling twelve lots of Octreotide Acetate for Injectable Suspension after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.
Chiesi USA is recalling three lots of Curosurf (poractant alfa) Intratracheal Suspension for lack of assurance of sterility.
Teva is recalling nine lots of Octreotide Acetate for Injectable Suspension 20 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.
Teva is recalling two lots of Octreotide Acetate for Injectable Suspension 10 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.
Apotex is recalling two lots of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution for lack of assurance of sterility.
Boston Scientific is recalling EndoVive Safety PEG Kits containing BD ChloraPrep Triple Swabsticks because open or compromised seals on the swabstick packaging could cause loss of sterility.