Hazard
473 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 473 sterility breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (6%) 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 breach 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.
Medline is recalling 135 Open Heart A Pack kits in California due to a potential sterile barrier breach in the RCSP cannulae, posing a risk of infection.
AVID Medical is recalling 98 Halyard IV Start Kits because wrinkles in the paper lidding may breach the seal, compromising sterility assurance.
Medline is recalling 2,080 eye and cataract preop kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
Medline is recalling approximately 996,692 blood draw and phlebotomy kits due to potential sterility breaches in the packaging. The defect may expose patients to microbial contamination.
Medline is recalling 3,650 blood culture kits nationwide due to potential packaging defects that may compromise sterility and expose patients to microbial contamination.
Medline is recalling 352 C-Section Prep kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
Medline is recalling 300 Ultrasound Breast Packs due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
Medline is recalling 3,752 Labor CDS and Vag Delivery Admission Bags due to packaging wrinkles that may compromise sterility, risking microbial contamination.
Medline is recalling 17,750 IVS Blood Culture Kits nationwide due to potential packaging defects that may compromise sterility.
Medline Industries is recalling 58,037 convenience kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
Medline is recalling 22,736 IV start kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
Medline Industries is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal defects that risk sterility breach during surgical procedures.
Medline is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal nonconformities that may compromise sterility. The defect could require extended surgery time to locate an alternative device.
Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.
Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose units due to a potential sterility breach in the sealing area of the sterile pouch. If used, the compromised sterility may result in moderate localized infection.
Zimmer Surgical Inc is recalling A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. If used, the issue may result in moderate localized infection.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which may compromise sterility.
One lot of Sterile Radiology Procedure Kits, model DYNDH1491B, is being recalled because of a potential breach in the sterile pouch packaging that may compromise sterility.
Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.
Sterilmed is recalling four reprocessed ACUSON AcuNav diagnostic ultrasound catheters because they were reprocessed beyond validated cycles.
Sterilmed is recalling six reprocessed ACUSON AcuNav diagnostic ultrasound catheters, the variant not for use with Siemens systems, because they were reprocessed beyond validated cycles.
Medline is recalling 1,024 Sterile Basic Eye Pack 16 kits because the pouch packaging may exhibit open seals.
Olympus is recalling 18,174 Single Use Electrosurgical Snares SD-400U-15 because sterility may be compromised by small holes formed during packaging or transportation.
Olympus is recalling 48,208 Single Use Electrosurgical Snares SD-400 because sterility may be compromised by small holes formed during packaging or transportation.
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with curved extensions, 12 Fr x 20 cm, over header bag seal integrity.