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Official recall record

RENASYS™ EDGE Negative Pressure Wound Therapy

Health Canada — Medical Devices · 2024-10-23 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-10-23
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Smith & Nephew Medical Ltd., has initiated a field action to voluntarily correct RENASYS™ EDGE devices. If the batteries are not appropriately maintained and charged as defined in the IFU (left in storage in an uncharged state), the battery may become depleted and be unable to recharge. The RENASYS™ EDGE device will operate on mains power and deliver therapy as intended. The device will show the charger is connected but will not increase battery charge percentage. Recall start date: October 2, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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