CLASS II ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report

Olympus Single use Biopsy Valve recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Olympus Single use Biopsy Valve, distributed nationwide in the US. The recall was initiated on 29 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: MAJ-210. UDI-DI: 14953170152433, 14953170452069. All Lot Numbers. 20 units per box.

Quantity recalled95,882 boxes (20 per box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1488-2026
FDA event ID: 98240
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jan 2026
FDA classified: 3 Mar 2026
Reported: 11 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Surgical Instruments

Timeline

29 Jan 2026	Recall initiated by company
3 Mar 2026	Classified by FDA	+33 days
11 Mar 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for rubber fragment detachment during use.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Olympus Single use Biopsy Valve recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Single use Biopsy Valve on 29 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1488-2026.

Why was it recalled?

Potential for rubber fragment detachment during use.

Which lots are affected?

Model/Catalog Number: MAJ-210. UDI-DI: 14953170152433, 14953170452069. All Lot Numbers. 20 units per box.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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