Home / Recalls / Olympus Corporation of the Americas / Z-0568-2024

Z-0568-2024 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
December 27, 2023
Initiation Date
October 2, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
162 pieces (27 boxes, 6 per box)

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,

Reason for Recall

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

Distribution Pattern

US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.

Code Information

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

Other recalls by Olympus Corporation of the Americas

  • Z-1694-2026 Class II — Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLT (February 27, 2026)
  • Z-1695-2026 Class II — Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE (February 27, 2026)
  • Z-1639-2026 Class II — Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product N (February 25, 2026)
  • Z-1638-2026 Class II — Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: E (February 25, 2026)
  • Z-1640-2026 Class II — Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Force (February 25, 2026)
  • Z-1644-2026 Class II — Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For (February 25, 2026)
  • Z-1641-2026 Class II — Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS C (February 25, 2026)
  • Z-1642-2026 Class II — Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For (February 25, 2026)
  • Z-1643-2026 Class II — Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutt (February 25, 2026)
  • Z-1612-2026 Class II — Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. (February 12, 2026)