Reported Dec 27, 2023 · Ongoing

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

Olympus Corporation of the Americas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229

Is this the product you have?

  • 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)
  • ModelREF 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)
  • ModelREF RB
Lot codes and dates
  • UDI-DI00821925036413 (Incorrect Right
  • Angle Cutting Loop pouch label) UDI-DI00821925036444 (Correct
  • on Roller Bar Electrode box label) LotKR260855
Amount recalled
162 pieces (27 boxes, 6 per box)

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

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