Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Smith & Nephew RENASYS-F XL with Soft Port REF #: Recalled by Smith & Nephew Inc. Due to Reports of wound fluid and /or blood that...
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
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Quantity: 15,754 indivdual units
Why Was This Recalled?
Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Smith & Nephew Inc.
Smith & Nephew Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report