# FDA recall Z-0516-2025

> **Smith & Nephew Medical, Ltd.** · Class II · device recall initiated 2024-10-02.

## Product

RENASYS EDGE    The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.

## Reason for recall

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

## Distribution

U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI  O.U.S.: Canada

## Key facts

- **Recall number:** Z-0516-2025
- **Recalling firm:** Smith & Nephew Medical, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-02
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hull, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2025

## Citation

> AI Analytics. FDA recall Z-0516-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0516-2025. Source: US FDA. Licensed CC0.

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