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USA Elite recallZ-0568-2024 · Olympus Corporation of the Americas · initiated Oct 2, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling Change Control

What the company is doing

An Urgent Medical Device Recall notice, issued via UPS Ground October 27, 2023, advises customers of the mislabeled product pouches. Customers are to examine and quarantine any affected inventory, contact Olympus customer service to arrange for return/replacement, and forward notice to any facility where product was further distributed. Acknowledge receipt of the recall notice through the Olympus recall portal at https://olympusamerica.com/recall (enter recall number "0432"). Customers requiring additional information may contact [email protected].

Recall details

Recall number
Z-0568-2024
Status
Open, Classified
Initiated by the company
Oct 2, 2023
Posted by the FDA
Dec 15, 2023
Recalling firm
Olympus Corporation of the Americas
Quantity
162 pieces (27 boxes, 6 per box)
Product code
FAS
FDA submissions
K890328
Distribution
US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.

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,

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

38 devices cleared under K890328 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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