medical Class II Updated 2023-12-27

Olympus Corporation of the Americas recalls ACMI Roller Bar Electrodes bearing incorrect pouch label of

Recalled 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,

Hazard / Issue

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

Issued by

FDA

Affected States: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI, WV

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

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