FDA Device recall Z-1067-2022
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018)
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) 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-1067-2022 |
| 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
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);
Reason
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Identifiers
| code_info | 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402573; 11278AC1 N/A Flexible Ureteroscop…11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402573; 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016) UDI Code: 4048551226353; 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402504; 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226377; 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226438; All Serial Numbers manufactured/distributed since January 2018. |
|---|
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-1067-2022%22
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