Olympus Corporation of the Americas: Roller Bar Electrodes Recalled for Incorrect Pouch Labeling

Agency Publication Date: December 15, 2023

Summary

Olympus is recalling approximately 162 ACMI Roller Bar Electrodes because the individual pouches are incorrectly labeled as 'Right Angle Cutting Loop Electrodes.' While the outer boxes (containing 6 pouches) are labeled correctly, the internal pouch labeling could lead a medical professional to believe they are using a different surgical tool than what is actually inside. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding these affected devices.

Risk

The incorrect labeling on the individual pouches may result in a surgical team preparing or attempting to use a Roller Bar electrode when a Right Angle Cutting Loop electrode is required, potentially leading to procedural delays or surgical complications.

What You Should Do

Identify affected products by checking for individual pouches labeled as 'ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012.'
Verify the lot number on the pouch or the outer box matches Lot: KR260855.
Check the Universal Device Identifier (UDI-DI) on the pouch label for 00821925036413 or on the box label for 00821925036444.
Immediately set aside any mislabeled pouches from Lot KR260855 and do not use them for surgical procedures.
Contact Olympus Corporation of the Americas or your healthcare provider for further instructions and information on the return or replacement process.
For additional questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Manufacturer consultation

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

Affected Products

Product: ACMI Roller Bar Electrodes (Box of 6)

Model / REF:

REF RB

REF MLE 24-012

Lot Numbers:

KR260855

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93417

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 162 pieces (27 boxes, 6 per box)

Distributed To: Alabama, Florida, Georgia, Kansas, Louisiana, Maryland, Michigan, North Carolina, New Jersey, New York, Texas, Wisconsin, West Virginia

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

What You Should Do

Identify affected products by checking for individual pouches labeled as 'ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012.'

Verify the lot number on the pouch or the outer box matches Lot: KR260855.

Check the Universal Device Identifier (UDI-DI) on the pouch label for 00821925036413 or on the box label for 00821925036444.

Immediately set aside any mislabeled pouches from Lot KR260855 and do not use them for surgical procedures.

Contact Olympus Corporation of the Americas or your healthcare provider for further instructions and information on the return or replacement process.

For additional questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).