# FDA recall Z-1644-2026

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

## Product

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm  Product Name: PKS Cutting Forceps  Model/Catalog Number: 920005PK  Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using   electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

## 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-1644-2026
- **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-1644-2026

## Citation

> AI Analytics. FDA recall Z-1644-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1644-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*