Olympus Corporation of the Americas: Single Use Distal Cover MAJ-2315 Recalled Due to Detachment Risk

Agency Publication Date: February 9, 2024

Summary

Olympus has recalled approximately 24,300 units of the Single Use Distal Cover (model MAJ-2315), which is used with the EVIS EXERA III Duodenovideoscope TJF-Q190V. The distal cover may unexpectedly detach from the scope during medical procedures, potentially leaving the component inside a patient's body. These covers were sold in boxes of 20 pieces and distributed nationwide across the United States.

Risk

If the cover detaches inside the body, it can cause internal injuries such as bleeding, tissue damage, or perforation (tears) in the gastrointestinal tract, requiring urgent surgery to remove. If the cover detaches in the throat, it may cause choking, airway obstruction, or respiratory distress; additionally, using the scope without the cover can result in internal burns.

What You Should Do

Identify if you have the affected product by checking the packaging for Single Use Distal Cover MAJ-2315 and UDI 04953170441271. This recall affects all lot numbers.
Check your inventory for these covers, which are typically used with the EVIS EXERA III Duodenovideoscope TJF-Q190V.
Contact your healthcare provider or Olympus Corporation of the Americas directly at 1-800-848-9024 for specific instructions regarding the continued use or return of these distal covers.
If you are a patient who has recently undergone a procedure with a duodenovideoscope and are experiencing unusual pain or respiratory issues, contact your doctor immediately.
For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Single Use Distal Cover MAJ-2315 (box of 20 pieces)

Model / REF:

MAJ-2315

TJF-Q190V

UPC Codes:

04953170441271

Lot Numbers:

All lot numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93732

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 24300 units (box of 20 pieces)

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 · 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.

Summary

Risk

What You Should Do

Identify if you have the affected product by checking the packaging for Single Use Distal Cover MAJ-2315 and UDI 04953170441271. This recall affects all lot numbers.

Check your inventory for these covers, which are typically used with the EVIS EXERA III Duodenovideoscope TJF-Q190V.

Contact your healthcare provider or Olympus Corporation of the Americas directly at 1-800-848-9024 for specific instructions regarding the continued use or return of these distal covers.

If you are a patient who has recently undergone a procedure with a duodenovideoscope and are experiencing unusual pain or respiratory issues, contact your doctor immediately.

For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.