EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 — Class I medical device recall Z-0057-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2025-10-22, distributed nationwide. Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used i
| Recall number | Z-0057-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-09-11 |
| Classified | 2025-10-16 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04953170342110 |
| Model numbers | BF-P190 |
Product
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Reason for recall
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
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-0057-2026. 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.