Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-0568-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 2, 2023

Date Posted: December 27, 2023

Recall Number: Z-0568-2024

Event ID: 93417

Reason for Recall:

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

Status: Ongoing

Product Quantity: 162 pieces (27 boxes, 6 per box)

Code Information:

UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated