FDA Device recall Z-2564-2021
BF-N20 OES Bronchofiberscope, Model No. BF-N20
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of BF-N20 OES Bronchofiberscope, Model No. BF-N20 by Olympus, citing the firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2564-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-16 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
BF-N20 OES Bronchofiberscope, Model No. BF-N20
Reason
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2564-2021%22
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