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
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.
AlabamaFloridaGeorgiaKansasLouisianaMarylandMichiganNorth CarolinaNew JerseyNew YorkTexasWisconsinWest 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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