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
Check against the official notice below — it lists the full affected range.
Karl Storz Endoscopy has recalled several models of flexible video ureteroscopes and cystoscopes distributed throughout the United States, Guam, Mexico, Lebanon, and South Korea. The recalled devices include the 11278V/11278VK CMOS Video Ureteroscope, the 11278VA/11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC), and the 11278VU/11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC), with all serial numbers manufactured or distributed since January 2018 affected by the recall.
The reason for the recall is that these devices fail to achieve the expected six-log reduction in microorganisms following the disinfection process, meaning they may not be adequately disinfected before use. The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Reason for recall: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,WI, WV, and WY. O.U.S.: Mexico, Lebanon, and South Korea Quantity: All Serial Numbers manufactured/distributed since January 2018. Lot/code info: 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016) UDI Code: 4048551276884; 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402580; 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018) UDI Code: 4048551278239; 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402634; All Serial Numbers manufactured/distributed since January 2018.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.