BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 — Class I medical device recall Z-0064-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2025-10-22, distributed nationwide. Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used i
| Recall number | Z-0064-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-09-11 |
| Classified | 2025-10-16 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04953170339998 |
| Model numbers | BF-TE2 |
Product
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Reason for recall
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.
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-0064-2026. 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.