Z-0568-2024Class II

ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle...

Name: Z-0568-2024 ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle...
Creator: Olympus Corporation of the Americas
Published: 2023-10-02
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-10-02 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2023-10-02. FDA classified it as Class II and gives the reason as "Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0568-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-02
Posted: 2023-12-15
Recalling firm: OLYMPUS Corporation of the Americas
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,
Product code: FAS Electrode, Electrosurgical, Active, Urological
Reason for recall: Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: An Urgent Medical Device Recall notice, issued via UPS Ground October 27, 2023, advises customers of the mislabeled product pouches. Customers are to examine and quarantine any affected inventory, contact Olympus customer service to arrange for return/replacement, and forward notice to any facility where product was further distributed. Acknowledge receipt of the recall notice through the Olympus recall portal at https://olympusamerica.com/recall (enter recall number "0432"). Customers requiring additional information may contact [email protected].
Quantity in commerce: 162 pieces (27 boxes, 6 per box)
Distribution: US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.
Product codes and lots: UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0568-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0568-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-15

Product code FAS

K890328Class IIAdult ResectoscopeCircon Video / cleared 1990-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)