Official recall notice

FDA DeviceClass IINotable

FDA Recall: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscop

Recall date
2026-07-15
FDA class
Class II

Why it was recalled

Hazard

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Product description

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Affected products

UDI/DI: 04953170441271, Lot Numbers: H2530 or later

Verify with the official notice →
Share:

Related Recalls

2026-09-02 · FDA_DEVICE
FDA Recall: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Elec
Olympus Corporation of the Americas
2026-07-29 · FDA_DEVICE
FDA Recall: Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit d
Olympus Corporation of the Americas
2026-07-29 · FDA_DEVICE
FDA Recall: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Olympus Corporation of the Americas
2026-07-22 · FDA_DEVICE
FDA Recall: Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Olympus Corporation of the Americas