Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Karl Storz Recalled by Karl Storz Endoscopy Due to During a complaint investigation it was determined that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Karl Storz Endoscopy directly.
Affected Products
Karl Storz, Model # 11161C2, Flexible Neuroscope
Quantity: 42 scopes
Why Was This Recalled?
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
Where Was This Sold?
This product was distributed to 28 states: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MD, MA, MI, MN, MO, NH, NJ, NC, OH, OR, PA, SC, TN, TX, VA, WA, WV, WI
About Karl Storz Endoscopy
Karl Storz Endoscopy has 70 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report