Olympus Corporation of the Americas: Medical Device Recall in 2026 - (Recall #: Z-1489-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 29, 2026

Date Posted: March 11, 2026

Recall Number: Z-1489-2026

Event ID: 98240

Reason for Recall:

Potential for rubber fragment detachment during use.

Status: Ongoing

Product Quantity: 1,276 boxes (20 units per box)

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated