# FDA recall Z-1640-2026

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

## Product

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm  Product Name: PK Cutting Forceps  Model/Catalog Number: PK-CF0533  Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

## 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-1640-2026
- **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-1640-2026

## Citation

> AI Analytics. FDA recall Z-1640-2026. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-1640-2026. Source: US FDA. Licensed CC0.

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