FDA recall Z-1489-2026

Olympus Corporation of the Americas · Class II · device

Product

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.

Reason for recall

Potential for rubber fragment detachment during use.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2026-01-29
Report date: 2026-03-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1489-2026