Olympus Duodenovideoscope Distal Cover may detach during gastrointestinal procedures
Olympus Single Use Distal Cover MAJ-2315 may detach from duodenovideoscopes during gastrointestinal procedures, risking perforation, retained objects requiring urgent removal, burns, and airway obstruction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with potential hazards including perforation and airway obstruction that could require urgent or immediate medical intervention. No actual illnesses or injuries are documented in the recall notice, fitting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the Single Use Distal Cover MAJ-2315, a protective cover designed to be attached to EVIS EXERA III Duodenovideoscope TJF-Q190V and other compatible Olympus duodenovideoscopes. The cover is meant to protect the distal end of the insertion tube and the forceps elevator during procedures.
The company has determined that the distal cover may unexpectedly detach from the duodenoscope during use. If detachment occurs within the gastrointestinal tract, the retained cover can cause mucosal injury, tissue damage, bleeding, perforation, or complete obstruction. These conditions require urgent medical intervention for removal. Additionally, if the duodenoscope distal end remains uncovered after the cover detaches, it may cause burns during the procedure.
If the cover detaches in the oral cavity, it poses a risk of aspiration, airway obstruction, or respiratory distress, all of which require immediate medical intervention for removal from the airway.
Healthcare facilities and users of the affected Olympus duodenoscopes should stop using the recalled distal covers immediately. The recall affects all lot numbers of the product (UDI: 04953170441271), with 24,300 units distributed nationwide. Any units already in use should be removed from service, and healthcare providers should contact Olympus Corporation of the Americas for guidance on replacement or alternative procedures.
The recalled product
- Product
- Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator
- Manufacturer
- Olympus Corporation of the Americas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 04953170441271 All lot numbers
Distribution
Distributed nationwide across the United States.
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