# FDA recall Z-1597-2024

> **Smith & Nephew Medical, Ltd.** · Class II · device recall initiated 2024-03-11.

## Product

RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing  Product Number:  66803140

## Reason for recall

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Chile.

## Key facts

- **Recall number:** Z-1597-2024
- **Recalling firm:** Smith & Nephew Medical, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-11
- **Report date:** 2024-04-24

- **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-1597-2024

## Citation

> AI Analytics. FDA recall Z-1597-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1597-2024. Source: US FDA. Licensed CC0.

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