FDA Device recall Z-0194-2024
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
- FDA Device
- Class I
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class I recall of EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 by Olympus, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0194-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-12 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Reason
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.
Identifiers
| code_info | Model BF-P190 UDI-DI: 4953170342110 |
|---|
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-0194-2024%22
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