Hazard
1,693 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 1,693 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 938 (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.
Maquet Cardiovascular is recalling specific adult specialty tubing sets for extracorporeal circulation 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 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 sterilization gas from reaching all fluid paths.
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling specific pediatric packs for extracorporeal circulation because a design issue may prevent proper sterilization of the stopcock ports.
Maquet Cardiovascular is recalling pediatric extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific Small Patient Tubing Packs because a design flaw may prevent proper sterilization, potentially compromising sterility.
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.
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.
Sagent Pharmaceuticals is recalling 75,825 vials of Ketorolac Tromethamine Injection because microbial growth was detected during a routine manufacturing simulation.
CMC Enterprise Pharmacy is recalling 40 syringes of Lidocaine 1% - Sodium Bicarb 8.4% 10:1 for intradermal use due to a lack of sterility assurance.
Anderson Compounding Pharmacy is recalling Testosterone Cypionate 250 mg/mL sterile injections because the product lacks sterility assurance.
Anderson Compounding Pharmacy is recalling HCG 23 Day vials nationwide due to a lack of sterility assurance. Consumers should stop using the product.
Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results indicate sterility cannot be assured.
Anderson Compounding Pharmacy is recalling HCG 20,000 units/vial products nationwide due to a lack of sterility assurance.
MSM Nutraceuticals is recalling Dry Eye Eye Drops because the product was not terminally sterilized and was not tested per USP 71.
Anderson Compounding Pharmacy is recalling 57 vials of HCG 30 Day due to a lack of sterility assurance. The products were distributed nationwide.
Anderson Compounding Pharmacy is recalling EDTA 1% Sterile Injection (Preservative Free) nationwide due to a lack of sterility assurance.
Anderson Compounding Pharmacy is recalling Serum Tears 30% Drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.
Anderson Compounding Pharmacy is recalling 35 vials of Estradiol Cypionate 10 mg/mL due to a lack of sterility assurance. The product was distributed nationwide.
Health Solutions Pharmacy Center is recalling compounded Papaverine-Phentolamine-PGE1 injectables because FDA inspectors observed insanitary conditions during the compounding of sterile drugs.
COVIDIEN LLC is recalling Kendall SCD Express Sterile Sleeves (Thigh Length) because they were distributed without undergoing sterilization.
Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results exceeded limits, meaning sterility cannot be assured.
US Compounding Inc is recalling 1,686 syringes of Ephedrine Sulfate 50 mg/10 mL because the company cannot ensure the product is sterile.
Promise Pharmacy, LLC is recalling specific lots of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.