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[Recalled] 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

recall fda device united-kingdom

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductRENASYS 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.
Brand / manufacturerSmith & Nephew Medical, Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0516-2025
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date02 October 2024
EAN / barcode66803126

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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