Hazard
580 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 580 sterilization failure recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 38 (7%) 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 sterilization 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.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria stated in the manual.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the Spanish operator manual lists an incorrect minimum drying time for sterilization trays.
Integra LifeSciences is recalling CUSA Clarity 36 kHz Sterilization Trays because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the Polish OPS Manual incorrectly states the minimum drying time for the 36 kHz Sterilization Tray.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Zimmer Biomet is recalling 92 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.
Zimmer Biomet is recalling 1,257 Comprehensive Reverse Shoulder Instrument Cases because they lack adequate sterilization validation. The products were distributed in the US and 16 foreign countries.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization.
Zimmer Biomet is recalling 89 units of the Small Diameter Cement Plug Inserter due to a lack of adequate sterilization validation.
American Contract Systems, Inc. is recalling 51,152 surgical convenience kits distributed in Florida because they may not have reached complete sterilization.
ASO, LLC is recalling Family Wellness First Aid Sterile Gauze Pads because they may not be fully sterilized. The affected units were distributed nationwide to ten states.
Safe N Simple, LLC is recalling 125 cases of Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified. The affected products were distributed in California.
Safe N Simple, LLC is recalling Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified.
Medline Industries is recalling 15 kits of Laparoscopy CDS because a non-sterile anti-fog component was not exposed to the sterilization process.
Medline Industries is recalling 77 kits of Cardiac Insulation Pads because a non-sterile component was not properly sterilized.
Medline Industries is recalling specific Bard MYPICC Kits because one case may not have been sterilized. The product was distributed to UT.
Fort Defiance Industries is recalling 199 P2131 Automated Field Steam Sterilizers because stagnant water and metal interactions can create deposits that interfere with the rear sight gauge or water liquid level switch.
Teleflex Medical Europe Ltd is recalling 573 units of Pilling Universal Shears because incorrect plastic was used for the handles, causing them to melt during sterilization.
TriMed Inc. is recalling 323 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.
TriMed Inc. is recalling 532 Nitinol staples because quarterly sterilization dose audit records could not be found, posing a risk of patient infection.
TriMed Inc. is recalling 1,194 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.
TriMed Inc. is recalling 706 units of Nitinol Surgical Staples because quarterly sterilization dose audits could not be verified, posing a potential infection risk.
Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.