Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) 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
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);
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