FDA Device recall Z-0061-2026
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
- FDA Device
- Class I
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class I recall of EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 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-0061-2026 |
| 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 II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
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-Q180; UDI: 4953170339301; 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-0061-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.