EVIS EXERA BF-XT160 Bronchofibervideoscope — Class II medical device recall Z-2497-2021
Terminated recall by Olympus Corporation of the Americas, reported 2021-09-29, distributed nationwide. A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a p
| Recall number | Z-2497-2021 |
|---|---|
| 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 | 2021-08-17 |
| Classified | 2021-09-21 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2024-01-12 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Model numbers | BF-XT160 |
Product
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Reason for recall
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
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-2497-2021. 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.