Olympus Single Use Distal Cover for Endoscope Recalled Due to Detachment Risk
Olympus is recalling about 309,278 single-use endoscope covers that may detach during use, risking aspiration, inhalation, obstruction, or burns.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—aspiration, obstruction, and burns from device detachment—is serious but theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported score High (3).
Plain-English summary
Olympus Corporation of the Americas is recalling the Single Use Distal Cover Model MAJ-2315 (Catalog #N5786100, UDI-DI: 04953170403019) used with the EVIS EXERA III Duodenovideoscope TJF-Q190V. Approximately 309,278 units with lot numbers lower than H2530 are affected and were distributed nationwide.
The distal cover may become detached from the endoscope during use and may cause mucosal injury. If the cover detaches during a procedure, aspiration, inhalation, or obstruction of the airway could occur and may require urgent removal. Burns from the uncovered distal end are also possible.
If you had a procedure using this device and experience persistent throat pain, difficulty swallowing, or signs of burns, contact your healthcare provider immediately. Healthcare facilities should discontinue use of this product and contact Olympus Corporation of the Americas for replacement units or further guidance.
The recalled product
- Product
- Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 309,278
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 (2)
- UDI-DI: 04953170403019
- Item code: Catalog N5786100 Lots Lower than H2530
Distribution
Distributed nationwide across the United States.
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