# FDA recall Z-2380-2021

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2021-06-09.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2380-2021
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-09
- **Report date:** 2021-09-08
- **Termination date:** 2023-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2380-2021

## Citation

> AI Analytics. FDA recall Z-2380-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2380-2021. Source: US FDA. Licensed CC0.

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