Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits Recalled by Smith & Nephew, Inc. Due to Sterility seal integrity failures on the Renasys Sterile...
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 Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.
Quantity: 45,455 devices (in the USA)
Why Was This Recalled?
Sterility seal integrity failures on the Renasys Sterile Transparent Film
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