FDA Device recall Z-0568-2024
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabili…
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabili… by Olympus, citing incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0568-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-02 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI, WV |
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.
Identifiers
| code_info | UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0568-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.