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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus Biopsy Valves Recalled for Potential Rubber Fragment Detachment

Agency Publication Date: March 3, 2026
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Summary

Olympus Corporation of the Americas is recalling approximately 97,158 Single Use Biopsy Valves, models MAJ-210 and MAJ-1218, because rubber fragments may detach from the valve during medical procedures. These valves are used with endoscopes to prevent the backflow or leakage of body fluids. If fragments detach, they could potentially enter a patient's body or obstruct the equipment. Olympus initiated this voluntary recall via letter on January 29, 2026.

Risk

Rubber fragments could break off the valve during use, posing a risk of foreign material entering the patient's body or interfering with the surgical procedure.

What You Should Do

  1. Identify if you have the affected valves by checking the model and catalog numbers on the product packaging: MAJ-210 (20 units per box) or MAJ-1218 (20 units per box).
  2. Check the UDI-DI codes on your boxes: for MAJ-210, look for 14953170152433 or 14953170452069; for MAJ-1218, look for 14953170154291.
  3. Stop using the recalled product.
  4. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions or to report an incident.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Olympus Single Use Biopsy Valve (20 units per box)
Model / REF:
MAJ-210
Lot Numbers:
All Lot Numbers
UDI:
14953170152433
14953170452069

Designed to prevent reflux of body fluids.

Product: Olympus Single Use Biopsy Valve (20 units per box)
Model / REF:
MAJ-1218
Lot Numbers:
All Lot Numbers
UDI:
14953170154291

Designed to prevent leakage of body fluids.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98240
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized distributors; Medical supply channels
Manufactured In: United States
Units Affected: 2 products (95,882 boxes (20 per box); 1,276 boxes (20 units per box))
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.