BF-P60 OES Bronchofiberscope — Class II medical device recall Z-2568-2021
Terminated recall by Olympus Corporation of the Americas, reported 2021-10-06, distributed nationwide. The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing
| Recall number | Z-2568-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2021-08-16 |
| Classified | 2021-09-24 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2024-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,030 |
| Reason classes | labeling |
| Serial numbers | BF-P60OES |
| Model numbers | BF-P60 |
Product
BF-P60 OES Bronchofiberscope, Model No. BF-P60
Reason for recall
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."
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2568-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.