FDA Device recall Z-1062-2022
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV by Karl Storz Endoscopy, citing failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1062-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-01 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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 |
Product
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
Reason
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Identifiers
| code_info | 11272V N/A Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313350; 11272VA 11272VAK Flexi…11272V N/A Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313350; 11272VA 11272VAK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551402481; 11272VU 11272VUK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551313367; 11272VUA 11272VUAK Flexible CMOS Video Cysto Urethroscope Z18446US-BE (01/2020) UDI Code: 4048551402559; All Serial Numbers manufactured/distributed since January 2018. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1062-2022%22
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