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Olympus Corporation of the Americas recalls ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loo
Recalled December 27, 2023 · FDA recall Z-0568-2024 · Olympus Corporation of the Americas
Hazard
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. · FDA Class II
Units
162 pieces (27 boxes, 6 per box)
Sold at
US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.
Description
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
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,
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →