ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA… — Class II medical device recall Z-0568-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2023-12-27, distributed in AL, FL, GA, KS, LA, MD, MI, NC…. Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
| Recall number | Z-0568-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-10-02 |
| Classified | 2023-12-15 |
| Reported by FDA | 2023-12-27 |
| Distributed | AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI, WV |
| Countries outside the US | CA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00821925036413, 00821925036444 |
| Lot numbers | KR260855 |
| Model numbers | 24-012 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0568-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.