# FDA recall Z-1069-2022

> **Karl Storz Endoscopy** · Class II · device recall initiated 2022-04-01.

## Product

11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);  11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);  11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018);  11278VSUA 11278VSUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);  11278VSUE 11278VSUEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020)

## 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

## Key facts

- **Recall number:** Z-1069-2022
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-01
- **Report date:** 2022-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Segundo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2022

## Citation

> AI Analytics. FDA recall Z-1069-2022. Retrieved 2026-05-31 from https://api.ai-analytics.org/recall/Z-1069-2022. Source: US FDA. Licensed CC0.

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