FDA Device recall Z-2012-2023
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
- FDA Device
- Class I
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class I recall of Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 by Olympus, citing there have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2012-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-06-08 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Reason
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Identifiers
| code_info | All serial numbers BF-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998 |
|---|
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-2012-2023%22
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