FDAOctober 12, 2023device
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
olympus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21122026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21112026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.2026-03-25
- FDAOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.2026-03-25
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