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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Olympus Forceps and Irrigation Plugs Recalled for Potential Contamination

Agency Publication Date: January 16, 2025
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Summary

Olympus Corporation of the Americas has recalled approximately 30,140 Olympus MAJ-891 Forceps/Irrigation Plugs (Isolated Type). These devices, which attach to endoscopes for irrigation and surgical access, may retain biological material if they are not completely disassembled and cleaned according to instructions. While no injuries have been reported, the manufacturer is notifying users by letter to ensure proper reprocessing procedures are followed.

Risk

If the device is not fully disassembled and cleaned between patients, biological material can remain trapped inside. This poses a risk of cross-contamination or infection to subsequent patients during medical procedures.

What You Should Do

  1. This recall affects the Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type) with model number MAJ-891 and UDI-DI 04953170063114. All lot numbers are included in this recall.
  2. Stop using the recalled device immediately if you cannot confirm it has been cleaned and disassembled according to the manufacturer's specific instructions.
  3. Contact Olympus Corporation of the Americas or your authorized medical distributor to arrange for the return, replacement, or correction of the device.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

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

Affected Products

Product: Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type)
Model / REF:
MAJ-891
Lot Numbers:
All lot numbers
UDI:
04953170063114

This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95898
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: authorized medical distributors; Olympus Corporation of the Americas
Manufactured In: United States
Units Affected: 30,140 units
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 FDA Press Release 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.