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Olympus MAJ-210 Single-Use Biopsy Valve Recalled for 95,882 Boxes Nationwide (2026)

Olympus Corporation of the Americas recalls 95,882 boxes of MAJ-210 single-use biopsy valves distributed nationwide to hospitals and clinics in the United States after reports of rubber fragments detaching during use. The defect can release fragments into the endoscope channel or patient. Healthcare facilities should stop using the device immediately and follow recall instructions.

Official notice
OlympusHealth & Personal CareMedical DevicesMAJ-2101495317015243314953170452069

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 29, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
January 29, 2026
Hazard Level
HIGH
Brand
Olympus
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Olympus
Product type
Single-use Biopsy Valve
Model numbers
MAJ-210, 14953170152433, 14953170452069
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 29, 2026

  2. Reported by FDA DEVICE

    March 11, 2026

  3. RecallRadar source check

    March 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Potential for rubber fragment detachment during use.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

About This Product

The MAJ-210 is a single-use biopsy valve designed to attach to the instrument channel port of compatible endoscopes to prevent reflux of body fluids during procedures.

Why This Is Dangerous

A rubber fragment can detach during use, creating a foreign-material risk inside the endoscope channel or patient.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics may experience procedure delays while devices are quarantined. Replacements will require supplier coordination and processing time.

Practical Guidance

How to identify if yours is affected

  1. Confirm model MAJ-210 is in use
  2. Verify packaging shows 20 units per box and total quantity of 95,882 boxes
  3. Discontinue use of affected devices immediately

Where to find product info

Refer to the FDA recall page and Olympus recall notifications for identifiers such as MAJ-210 and the UDI-DI codes

What timeline to expect

Refunds or replacements typically take 4-8 weeks after initiating the claim

If the manufacturer is unresponsive

  • Escalate to a supervisor at Olympus
  • File a complaint with the FDA if manufacturer responsiveness is insufficient
  • Consider seeking legal counsel for remedies if needed

How to prevent similar issues

  • Verify recall status before purchasing endoscope accessories
  • Check UDI-DI codes on packaging before use
  • Source devices directly from official manufacturer channels

Documentation advice

Keep copies of recall notices, order records, shipment details, and all correspondence with Olympus

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Product Details

Model/Catalog Number: MAJ-210; UDI-DI: 14953170152433; Additional UDI: 14953170452069; 20 units per box; Quantity recalled: 95,882 boxes; Sold/distributed: US nationwide; Status: Active recall; Recall date: 2026-01-29; Remedy: Stop use and follow manufacturer recall instructions; Manufacturer: Olympus Corporation of the Americas.

Key Facts

  • 95,882 boxes recalled (20 units per box)
  • Total units affected: 1,917,640
  • Distribution: US nationwide
  • Hazard: rubber fragments may detach during use

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
MAJ-210
14953170152433
14953170452069
Affected States
ALL
Report Date
March 11, 2026
Recall Status
ACTIVE

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