Hazard
574 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 574 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 34 (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 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.
Zavation's 11G Diamond Trocar/Cannula, used in orthopedic and spinal procedures, may not have been adequately sterilized. The manufacturer is recalling affected units distributed nationwide.
CLINICAL LASERTHERMIA SYSTEMS AB is recalling the Tranberg MR Cannula due to potentially inadequate sterilization of certain lots. Affected units were distributed to medical facilities in the US and internationally.
Terumo recalled the HX2 and TCM temperature management systems used in cardiac surgery due to inability to validate an updated cleaning protocol. Users should discontinue use and properly dispose of affected devices.
Zavation recalls ZVplasty Unipedicular Cement Delivery Cannula Kit (72 units nationwide) due to sterilization failure. Products distributed as sterile may not have been adequately sterilized.
Biopsybell S.R.L. is recalling 60 units of Renova Spine Bone Filler labeled as sterile but potentially not sterilized. The product was distributed in Mississippi and Kentucky.
Biopsybell is recalling 10G Direct Working Cannulas labeled as sterile because they may not have been sterilized. The recall affects 50 units distributed in Mississippi and Kentucky.
Boston Scientific is retrieving five ACUITY Universal Cutters that did not undergo the required sterile processing procedure.
Biomet is recalling OnPoint Scope Procedure Kits because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.
Biomet is recalling Regenerex Primary Taper Caps because they were not properly aligned for gamma sterilization, potentially leaving them unsterilized.
Biomet is recalling ARTHROSIMPLICITY KIT EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.
Medline Industries is recalling 20 non-sterile radiology kits that were sold to accounts without the ability to sterilize them prior to use.
Integra LifeSciences is recalling 74 units of 13 ft handpiece cables used in dermatome sets because the cables melt after sterilization.
Medtronic Perfusion Systems is recalling 10 extra corporeal circuits with bio-active surfaces because they failed a sterilization test. The units were distributed only to California and Michigan.
Biomet is recalling 705 units of Screw Instrument Trays because the device and tray failed steam sterilization process validation testing.
Biomet is recalling 136 units of the Outer Sheath 4.5/5.0,6.5 because the device and tray failed steam sterilization validation testing.
Olympus is recalling 18 ShockPulse-SE Lithotripsy System transducers because a component was made with non-conforming material that could allow water ingress during sterilization.
Karl Storz is recalling 21 RHINO-LARYNGO-BRONCHO FIBERSCOPE units because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
Fresenius Medical Care is recalling 32,592 bags of Sodium Chloride 0.9% Injection because chemical indicators were not positioned properly during sterilization.
Medline Industries is recalling 122 units of HOI Lumbar Complete Delivery Systems because the sterile packs did not complete a sterilization cycle, compromising sterility.
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 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 C7000 CUSA Clarity systems because the Spanish operator manual lists an incorrect minimum drying time for sterilization trays.
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.
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 CUSA Clarity 36 kHz Sterilization Trays because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.