11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1 — Class II medical device recall Z-1065-2022
Ongoing recall by Karl Storz Endoscopy, reported 2022-05-18, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
| Recall number | Z-1065-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2022-04-01 |
| Classified | 2022-05-12 |
| Reported by FDA | 2022-05-18 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, WY |
| Countries outside the US | KR, LB, MX |
| Quantity | 2,018 |
| UPC / GTIN / UDI-DI | 04048551431382, 04048551444351 |
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)
Reason for recall
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1065-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.