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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
January 29, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
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
- Confirm model MAJ-210 is in use
- Verify packaging shows 20 units per box and total quantity of 95,882 boxes
- 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
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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