Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) Recalled by Smith & Nephew, Inc. Due to Modification were made to the RENASYS EZ NPWT...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew, Inc. directly.
Affected Products
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
Quantity: 2,142 units
Why Was This Recalled?
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Smith & Nephew, Inc.
Smith & Nephew, Inc. has 220 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report