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Medium risk Medical DevicesClass II

Olympus MAJ-1218 Biopsy Valve Recall

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 inst

Updated January 29, 2026

Olympus Single Use Biopsy Valve (Model MAJ-1218) has been recalled because rubber fragments can detach during use. If fragments enter the endoscope or are not removed before reuse, they could affect device function or patient safety.

Is the Olympus Corporation of the Americas recalled? Yes. This product was recalled by FDA on January 29, 2026. Details below.

What is recalled

Olympus Single Use Biopsy Valve, Model/Catalog Number MAJ-1218, sold in boxes of 20 units. This valve is designed to attach to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.

Am I affected

You're affected if you use or stock Olympus MAJ-1218 biopsy valves for endoscope procedures. Check the model number on the valve packaging or medical device records.

What to do right now

Stop using MAJ-1218 valves immediately. Contact Olympus Corporation of the Americas for instructions on replacement or return of affected units.

The hazard

Potential for rubber fragment detachment during use.

Brands affected

Olympus Corporation of the Americas
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1489-2026
Classification
Class II
Recalled
January 29, 2026
Read the official notice

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