Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0516-2025 — 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.

U.S. FDA — Device Enforcement · United Kingdom · 2024-10-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0516-2025
Date of alert: 2024-10-02
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew Medical, Ltd.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 66803126

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0516-2025 — 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.

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