Data Foundry

Medical device recalls 2023

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180 — Class I medical device recall Z-0191-2024

Ongoing recall by Olympus Corporation of the Americas, reported 2023-11-15, distributed nationwide. There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxyge

Recall numberZ-0191-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmOlympus Corporation of the Americas, Center Valley, PA, United States
Recall initiated2023-10-12
Classified2023-11-09
Reported by FDA2023-11-15
DistributedNationwide (US)
Quantity13,950 devices
Model numbersBF-1T180, BF-1TQ180, BF-P180

Product

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180

Reason for recall

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

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-0191-2024. 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.