---
title: "ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite Sy... — FDA record Z-0568-2024 | Is It on Recall"
description: "Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes."
url: https://isitonrecall.com/recall/fda-device-z-0568-2024-acmi-roller-bar-electrodes-bearing-incorrect-pouch-label-of-acmi-usa-elite-system-and-usa-series-rig/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting ... — FDA record Z-0568-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 2, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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,
- **Reason**: Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
- **Classification**: Class II
- **Recalling firm**: Olympus Corporation of the Americas
- **Quantity**: 162 pieces (27 boxes, 6 per box)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0568-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0568-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alabama](https://isitonrecall.com/state/alabama/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)

## Dates in the source

- **Report date**: Dec 27, 2023
- **Recall initiation date**: Oct 2, 2023
- **Center classification date**: Dec 15, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0568-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Olympus Corporation of the Americas records](https://isitonrecall.com/brand/olympus-corporation-of-the-americas/)