The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1489-2026·Announced 2026-03-11

Olympus biopsy valve MAJ-1218 may shed rubber fragments during use

Olympus is recalling all lots of its Single Use Biopsy Valve, model MAJ-1218, because of the potential for rubber fragment detachment during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: fragments may detach from a device attached to an endoscope during a procedure, and no injuries are stated in the source.

Plain-English summary

Olympus Corporation of the Americas is recalling the Olympus Single Use Biopsy Valve, model MAJ-1218, supplied 20 units per box. The valve is designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids. About 1,276 boxes were distributed nationwide in the United States. The FDA has classified this recall as Class II.

There is potential for rubber fragment detachment during use.

All lot numbers are affected. The product carries UDI-DI 14953170154291.

Facilities can identify affected valves by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.

The recalled product

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.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopy
Hazard

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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