Class IIReported 2026-03-11

Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.

Recalled by Olympus Corporation of the Americas

Reason for Recall

Potential for rubber fragment detachment during use.

Recall Number

Z-1489-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-29

Reported

2026-03-11

Distribution

US Nationwide distribution.

Code Info

Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.