Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) Recalled by Karl Storz Endoscopy Due to Failure to achieve the expected six-log reduction in...
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
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)
Quantity: All Serial Numbers manufactured/distributed since January 2018.
Why Was This Recalled?
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Karl Storz Endoscopy
Karl Storz Endoscopy has 70 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report