Karl Storz Endoscopy recalls 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video

Recalled May 18, 2022 · FDA recall Z-1065-2022 · Karl Storz Endoscopy

Hazard

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. · FDA Class II

Units

All Serial Numbers manufactured/distributed since January 2018.

Sold at

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

Description

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Product

11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)

Manufacturer(s)

Karl Storz Endoscopy

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →