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FDAOctober 2, 2023device

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 Se...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0082192503641300821925036444

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 Se... — Recall Details · AllClear