FDA Device recall Z-0066-2026
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
- FDA Device
- Class I
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class I recall of EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 by Olympus, citing 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-frequenc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0066-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-09-11 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Reason
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.
Identifiers
| code_info | Model No. BF-XT190; UDI: 4953170402470; All Serial No. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0066-2026%22
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