Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI Recalled by Olympus Corporation of the Americas Due to Mislabeling

Date: October 2, 2023
Company: Olympus Corporation of the Americas
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.

Affected Products

ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,

Quantity: 162 pieces (27 boxes, 6 per box)

Why Was This Recalled?

Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

Where Was This Sold?

This product was distributed to 13 states: AL, FL, GA, KS, LA, MD, MI, NJ, NY, NC, TX, WV, WI

Affected (13 states)Not affected

About Olympus Corporation of the Americas

Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report