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.
Cipla is recalling 8,136 bottles of Difluprednate ophthalmic emulsion nationwide due to defective container caps that can break and expose the medication tip, compromising sterility.
McKesson Medical-Surgical is recalling Paracentesis/Thoracentesis Trays that were subjected to temperature abuse during distribution, which may compromise the sterility and efficacy of the included Lidocaine Hydrochloride. No illnesses have been reported.
McKesson Medical-Surgical is recalling Bupivacaine Hydrochloride Injection due to temperature abuse during storage that may have compromised product sterility. The recall affects 224 cartons distributed nationwide.
McKesson is recalling Miochol E intraocular solution due to temperature abuse during distribution. The product should not be used if received between June 1 and September 30, 2021.
McKesson is recalling Baxter Sterile Water for Injection USP (2000 mL) distributed nationwide due to temperature abuse during manufacturing that may compromise sterility.
McKesson Medical-Surgical is recalling Bupivacaine HCl Injection due to cGMP deviations caused by temperature abuse during manufacturing. The recall affects 32 cartons of 25-vial packages distributed nationwide.
Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.
Johnson & Johnson Surgical Vision is recalling tray ring covers (Model OM271000) worldwide due to a potential breach in the sterility barrier that could allow contamination.
B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP due to leaking that compromises sterility assurance. The intravenous medication was distributed nationwide.
Boston Scientific is recalling 7,695 units of HYDRATOME RX devices worldwide due to compromised sterility from a sterile barrier breach. Affected devices may pose a risk of infection.
Boston Scientific has recalled 3,578 units of the JAGTOME RX medical device due to sterility compromise from a barrier breach. Affected units were distributed worldwide.
Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.
Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.
Collagen Matrix is recalling 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane due to unsealed outer packaging that may compromise product sterility and increase infection risk.
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential packaging deformation that could compromise the sterile barrier. Approximately 2,720 units were distributed nationwide for use in brain recording and stimulation procedures.
FlexDex Inc. is reinforcing instructions for the 8mm FlexDex Needle Driver (Product Code FD-335 ND). Users should not use the product if packaging shows any damage, including pinholes or tears.
Beaver Visitec International recalls 920 units of Malosa Core LASIK Pack due to packaging holes that may compromise product sterility. Compromised sterility creates infection risk in surgical use.
Beaver Visitec International is recalling the Malosa Core SMILE Pack 1-Medical Refractive Kit because packaging may contain small holes that compromise sterility. The recall affects 680 units distributed in nine states.
Beaver Visitec is recalling Malosa Core Phaco Pack 1 cataract surgery kits (Part Number: MMK833/2) because packaging may have small holes that compromise product sterility. The recall affects 120 units distributed across nine states.
Beaver Visitec is recalling the Malosa Core Surface Treatment Pack surgical kit because packaging may have holes that compromise sterility during eye procedures.
Beaver Visitec is recalling 1,170 units of its Malosa Core SMILE Pack 2 surgical refractive kit because packaging may contain small holes that could compromise sterility. Affected units were distributed across nine states.
Beaver Visitec International is recalling the Malosa Core Phaco Pack 2 medical refractive kit due to small holes in the kit packaging that may compromise product sterility.
Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.
Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.
Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.