11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
Check against the official notice below — it lists the full affected range.
Karl Storz Endoscopy is recalling multiple models of CMOS Video Cysto-Urethroscopes (models 11272V, 11272VA, 11272VAK, 11272VU, 11272VUK, 11272VUA, and 11272VUAK) with all serial numbers manufactured or distributed since January 2018. The devices are being recalled because they fail to achieve the expected six-log reduction in microorganisms following the disinfection process, which means they may not be adequately disinfected before use.
The recalled devices were distributed throughout the United States, including all 50 states, the District of Columbia, and Guam, as well as internationally in Mexico, Lebanon, and South Korea. The record 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: 11272V N/A Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313350; 11272VA 11272VAK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551402481; 11272VU 11272VUK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313367; 11272VUA 11272VUAK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551402559; 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.