Hazard
2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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.
Medtronic Vascular is recalling 137 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.
Medtronic Vascular is recalling 6F Launcher Guide Catheters because an unsealed pouch may compromise sterility.
Boston Scientific is recalling Captivator, Captiflex, and Sensation polypectomy snares because users reported incomplete pouch seals before use.
Becton Dickinson is recalling 155,200 10 ml syringes because open packaging seals may compromise sterility. The product was distributed in the US and Canada.
Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Aomori Olympus is recalling Crescent Snare devices due to inadequate package seals that may compromise sterility, posing an infection risk.
Aomori Olympus Co., Ltd. is recalling KD-620UR Electrosurgical Snare units because inspection found inadequate package seals, which could compromise sterility and lead to patient infection.
Aomori Olympus Co., Ltd. is recalling Crescent Snare models due to inadequate package seals that may compromise sterility and increase infection risk.
Aomori Olympus is recalling NA-411D-1321 aspiration needles because inspection found some sterile packages have inadequate seals, posing an infection risk.
Edge Pharma, LLC is recalling 71 syringes of Methotrexate USP Sterile Solution for Injection because the media used for post-compounding sterility testing was expired.
Medtronic is recalling 1,926 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.
Merit Medical Systems is recalling 42 custom embolization kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.
Medtronic is recalling Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase the risk of post-operative infection.
Merit Medical Systems is recalling 90 custom angiography kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.
Merit Medical Systems is recalling 80 cardiac catheterization kits because header bags may not be fully sealed, potentially compromising sterility and increasing infection risk.
Medtronic is recalling 3,858 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.
Medtronic is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
Medtronic is recalling 15 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
Medtronic is recalling 3 units of Cardioblate CryoFlex Surgical Ablation Probes because of a potential defect in the sterile barrier pouch seals.
Medtronic is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe due to potential defects in the sterile barrier pouch seals.
ICU Medical is recalling specific lots of NanoClave Manifold sets because a manufacturing defect may prevent a proper seal with the spike.
Medline Industries is recalling Central Line Dressing Change Trays because incomplete seals may compromise sterility. The recall affects kits distributed in Minnesota and Texas.
Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.
EMD Serono is recalling 30,756 vials of Cetrotide because missing rubber stoppers could compromise sterility assurance.
TeDan Surgical Innovations is recalling 1,965 sterile Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile claim.