Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.
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.