EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190 — Class I medical device recall Z-0192-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2023-11-15, distributed nationwide. There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxyge
| Recall number | Z-0192-2024 |
|---|---|
| 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 | 2023-10-12 |
| Classified | 2023-11-09 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 32,211 devices |
| UPC / GTIN / UDI-DI | 04953170335174, 04953170335181, 04953170335198, 04953170342912 |
| Model numbers | BF-1TH190, BF-H190, BF-Q170, BF-Q190 |
Product
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Reason for recall
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
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-0192-2024. 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.