Data Foundry

Medical device recalls 2025

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 — Class I medical device recall Z-0067-2026

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 numberZ-0067-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmOlympus Corporation of the Americas, Center Valley, PA, United States
Recall initiated2025-09-11
Classified2025-10-16
Reported by FDA2025-10-22
DistributedNationwide (US)
Model numbersBF-XT40

Product

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

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-0067-2026. 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.