Quick Facts at a Glance
- Recall Date
- January 29, 2026
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- 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 Corporation of the Americas
- Product type
- Single Use Biopsy Valve
- Model numbers
- MAJ-1218
- 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-1218 is a single-use biopsy valve designed to attach to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Why This Is Dangerous
Rubber fragments detaching during use could contaminate the procedural field or injure the patient, requiring medical evaluation.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Healthcare facilities using MAJ-1218 valves may need to quarantine affected inventory and follow recall procedures, potentially impacting procedural workflows and supply chains.
Practical Guidance
How to identify if yours is affected
- Verify model: MAJ-1218 on packaging or device label.
- Confirm quantity: 1,276 boxes (20 units each).
Where to find product info
UDI-DI on box labeling and packaging; recall notice URL.
What timeline to expect
Refunds or replacements processed after a recall, typically within weeks as directed by Olympus.
If the manufacturer is unresponsive
- Escalate to hospital procurement or risk management.
- File a consumer complaint with the appropriate regulatory body if needed.
How to prevent similar issues
- Verify device compatibility and UDI before use.
- Implement quarantine of affected inventory.
- Keep recall documents for audit purposes.
Documentation advice
Retain recall notice, packaging, lot numbers, and correspondence with Olympus for records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. 20 units per box. Quantity recalled: 1,276 boxes. Distribution: US Nationwide. All lot numbers affected. Intended use: Attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Key Facts
- 20 units per box
- All lot numbers affected
- Nationwide distribution in the US
- Immediate stop-use instruction
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.