Olympus Corporation of the Americas: Medical Device Recall in 2021 - (Recall #: Z-2380-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC

Product Classification:

Class II

Date Initiated: June 9, 2021

Date Posted: September 8, 2021

Recall Number: Z-2380-2021

Event ID: 88448

Reason for Recall:

Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.

Status: Terminated

Product Quantity: 6 boxes (5 per/box)=30 units

Code Information:

Lot number KR121617

Distribution Pattern:

US Nationwide distribution in the states of CA, GA, MN, TN.

Voluntary or Mandated:

Voluntary: Firm initiated