CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report

Acmi Roller Bar Electrodes bearing incorrect pouch label recalled

Olympus Corporation of the Americas is recalling Acmi Roller Bar Electrodes bearing incorrect pouch label of Acmi Usa Elite System and Usa, distributed in 13 states. The recall was initiated on 2 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855

Quantity recalled162 pieces (27 boxes, 6 per box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0568-2024
FDA event ID: 93417
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Oct 2023
FDA classified: 15 Dec 2023
Reported: 27 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

2 Oct 2023	Recall initiated by company
15 Dec 2023	Classified by FDA	+74 days
27 Dec 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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,

Where it was distributed

US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.

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

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855

Where was it sold?

US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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