# FDA recall Z-0568-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-10-02.

## 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 for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0568-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-02
- **Report date:** 2023-12-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0568-2024

## Citation

> AI Analytics. FDA recall Z-0568-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0568-2024. Source: US FDA. Licensed CC0.

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