Recall Z-1489-2026— Olympus Corporation of the Americas

Name: FDA recall Z-1489-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-29

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-01-29. It names one FDA 510(k) clearance: K061313. 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: Potential for rubber fragment detachment during use..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-01-29
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K061313 — EVIS EXERA 180 SYSTEMOlympus Medical Systems Corporation·cleared 2006-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.