Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016) 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
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK 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