FDA Device recall Z-1055-2022
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) 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-1055-2022 |
| 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 | US |
Product
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Reason
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Identifiers
| code_info | 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 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-1055-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.