11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA — Class II medical device recall Z-1055-2022
Ongoing recall by Karl Storz Endoscopy, reported 2022-05-18, distributed nationwide. Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
| Recall number | Z-1055-2022 |
|---|---|
| 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 | 2022-05-10 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,018 |
| UPC / GTIN / UDI-DI | 04048551225738 |
Product
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
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-1055-2022. 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.