Karl Storz Endoscopy: Medical Device Recall in 2022 - (Recall #: Z-1068-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);

Product Classification:

Class II

Date Initiated: April 1, 2022

Date Posted: May 18, 2022

Recall Number: Z-1068-2022

Event ID: 89880

Reason for Recall:

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

Status: Ongoing

Product Quantity: All Serial Numbers manufactured/distributed since January 2018.

Code Information:

11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016) UDI Code: 4048551276884; 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402580; 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018) UDI Code: 4048551278239; 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020) UDI Code: 4048551402634; All Serial Numbers manufactured/distributed since January 2018.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated