# FDA recall Z-1896-2025

> **Silex Medical, LLC** · Class II · device recall initiated 2024-01-09.

## Product

Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.

## Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

## Distribution

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

## Key facts

- **Recall number:** Z-1896-2025
- **Recalling firm:** Silex Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-09
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Southington, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1896-2025

## Citation

> AI Analytics. FDA recall Z-1896-2025. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1896-2025. Source: US FDA. Licensed CC0.

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