# FDA recall Z-1641-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2026-02-25.

## Product

Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm  Product Name: HALO PKS Cutting Forceps  Model/Catalog Number: HACF0533  Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation   is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.

## Reason for recall

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

## Distribution

Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.

## Key facts

- **Recall number:** Z-1641-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-25
- **Report date:** 2026-04-01

- **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-1641-2026

## Citation

> AI Analytics. FDA recall Z-1641-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1641-2026. Source: US FDA. Licensed CC0.

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