Hazard
663 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) 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 assurance 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.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the fluid path.
Maquet Cardiovascular is recalling specific ECC pump packs because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-T 8803#Circ Circuit Small Patient tubing sets because the sterilization process may not ensure sterility in the stopcock ports.
Maquet Cardiovascular is recalling specific infant extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization.
Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization of stopcock ports.
Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing sets because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of stopcock ports.
Maquet Cardiovascular is recalling specific infant custom tubing sets for extracorporeal circulation because the sterilization process may not have ensured sterility at the stopcock ports.
CMC Enterprise Pharmacy is recalling 715 bags of Vancomycin 1500 mg in NS 250 mL due to a lack of sterility assurance. The product was distributed in North Carolina.
Medical Action Industries is recalling specific lots of laparotomy sponges due to a potential lack of sterility assurance. The affected products were distributed nationwide and to Canada and Saudi Arabia.
Cardinal Health Inc. is recalling 182 Presource Kit Total Joint Packs distributed in Florida because the double-wrapped basin component is not supported by current sterility assurance validation.
Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.
Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.
Stryker is recalling 732 units of Revolution CMS orthopedic cement mixers because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.
Stryker is recalling specific lots of Femoral Canal Pressurizers because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.
Stryker is recalling InterPulse Handpieces because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Adenosine Injection because of a lack of sterility assurance. The recall covers products distributed nationwide.
Pharmedium Services, LLC is recalling all lots of Labetalol HCl nationwide due to a lack of sterility assurance.
SSM St. Clare Health Center is recalling specific lots of compounded Oxytocin IV bags due to a lack of sterility assurance. No distributed product has been identified as actually containing microorganisms.
Vital Rx, Inc. is recalling all sterile products due to poor aseptic production practices identified during an FDA inspection.
Pfizer is recalling 115,370 vials of Hydromorphone Hydrochloride Injection because a damaged sterilizing filter may have compromised sterility assurance during manufacturing.
Cantrell Drug Company is recalling specific lots of Succinylcholine Chloride Injection Solution due to a lack of sterility assurance.