Hazard
36 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 36 improper sterilization recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) 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 improper sterilization 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.
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.
Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.
Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.
Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
American Contract Systems is recalling 290 cardiac procedural kits nationwide because components were subjected to sterilization without documented assessment of temperature suitability, potentially causing loss of functionality or efficacy.
Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.
Atrium Oasis chest drain devices were re-sterilized by a third party using unapproved packaging and sterilization processes lacking manufacturer validation. Affected devices were distributed in Virginia.
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.
American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization residuals.
FDA recalls 130,250 bags of oxyTOCIN IV solution from CAPS, Inc., distributed nationwide, due to lack of validated sterilization procedures. No illnesses reported.
FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.
Smiths Medical is recalling 2,101 DuraLife Autoclavable Silicone Extension Tubes due to inadequate sterilization instructions. The product documentation does not specify cleaning methods, autoclave cycle duration, or the number of reuse cycles allowed per patient.
American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.
American Contract Systems is recalling various eye and cataract surgery packs distributed to US health systems because the products were exposed to multiple sterilization cycles without validation. Unvalidated sterilization may compromise device sterility.
American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.
Olympus bronchovideoscopes are recalled due to updates required for proper sterilization and reprocessing procedures. Healthcare providers must follow new instructions for chemical disinfection and ETO gas sterilization.
Olympus is updating instructions for reprocessing and sterilizing BF-MP60 bronchofiberscopes to ensure proper procedures. All 60 units distributed nationwide are affected.
American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.
Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.
Karl Storz Udel Sterilization Tray instructions for use have been updated to correct sterilization methods and clarify endoscope compatibility. Ethylene oxide is now excluded as a sterilization modality.
Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.