SINGLE USE BIOPSY VALVE recallZ-1488-2026 · Olympus Corporation of the Americas · initiated Jan 29, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for rubber fragment detachment during use.

FDA root cause category: Under Investigation by firm

What the company is doing

Olympus notified consignees on about 01/29/2026 via letter titled URGENT: FIELD SAFETY NOTICE. Consignees were instructed to carefully read the content of the notification, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, and that they may continue using the devices as per the notification and instructions for use. Olympus is highlighting the importance of strictly adhering to the Inspection of the Biopsy Valve and Inserting and Withdrawing the Endo-therapy accessories sections in the IFU related to the detachment of fragment from the slit part of rubber. Consignees were requested to acknowledge receipt of the notification via their portal and if product has been further distributed to notify those consignees.

Recall details

Recall number: Z-1488-2026
Status: Open, Classified
Initiated by the company: Jan 29, 2026
Posted by the FDA: Mar 3, 2026
Recalling firm: Olympus Corporation of the Americas
Quantity: 95,882 boxes (20 per box)
Product code: EOQ
FDA submissions: K061313
Distribution: US Nationwide distribution.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

SINGLE USE BIOPSY VALVE MAJ-210
Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)
1 recall221 reports

Product lines

SINGLE USE BIOPSY VALVEOlympus Medical Systems Corp. · 3 models · 227 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 98240).

Z-1489-2026 · Open, Classified
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 endos…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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