11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
Check against the official notice below — it lists the full affected range.
Karl Storz is recalling two models of flexible video cysto-urethroscopes: the 11272VUE/11272VUEK and the 11272VUE-R/11272VUEK-R (version 1.1 from April 2021). The devices fail to achieve the expected six-log reduction in microorganisms during the disinfection process, meaning they may not be adequately disinfected for patient use. All serial numbers of these devices manufactured or distributed since January 2018 are affected.
The recalled devices were distributed throughout the United States (including all 50 states, Washington D.C., and Guam), as well as in Mexico, Lebanon, and South Korea. The recall record does not specify a remedy or recommended action for consumers who possess these devices.
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: 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021) UDI Code: 4048551431382; 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021) UDI Code: 4048551444351; 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.