11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Check against the official notice below — it lists the full affected range.
Karl Storz Endoscopy is recalling certain flexible cystoscope models (11274BCU1 and 11274BCUK1, model Z18449US-BD from August 2018) because they may fail to achieve the expected six-log reduction in microorganisms during the disinfection process. This means the devices may not be properly disinfected to the required standard. The affected devices include all serial numbers manufactured or distributed since January 2018.
The recalled cystoscopes were distributed across the United States, including all 50 states, Washington D.C., Guam, as well as Mexico, Lebanon, and South Korea. The source does not specify a remedy or recommended action for consumers who may have 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: 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) UDI Code: 4048551408155 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.