FDA Devices Moderate Class II Ongoing

11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)

Reported: May 18, 2022 Initiated: April 1, 2022 #Z-1066-2022

Product Description

Reason for Recall

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

Details

Recalling Firm: Karl Storz Endoscopy
Units Affected: All Serial Numbers manufactured/distributed since January 2018.
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
Location: El Segundo, CA

Frequently Asked Questions

What product was recalled? ▼

11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018). Recalled by Karl Storz Endoscopy. Units affected: All Serial Numbers manufactured/distributed since January 2018..

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1066-2022.