Smith & Nephew RENASYS Soft Port Dressing Kits Recalled for Sealing Defects
Smith & Nephew is recalling RENASYS Soft Port Dressing Kits because inadequate sealing may prevent wound fluid evacuation and fail to trigger pump alarms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device failure that could lead to inefficient wound treatment and failure of safety alarms, representing a risk of harm where specific injury counts are not detailed in the provided text.
Plain-English summary
Smith & Nephew Inc. is recalling 162,629 units of the RENASYS Soft Port Dressing Kits (REF: 66800799). These kits are used in conjunction with negative pressure wound therapy pumps. The recall covers all lot numbers 2013010311 and lower.
The recall was initiated due to reports of wound fluid and/or blood not being evacuated from beneath the wound dressing, with the pump blockage alarm failing to activate. The FDA attributes these issues to 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 wound.
The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous international locations such as Australia, Germany, France, and Singapore. Users should stop using the affected kits and contact Smith & Nephew for instructions on replacement or return.
The recalled product
- Product
- Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
- Manufacturer
- Smith & Nephew Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 162,629
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL LOT #s 2013010311 and lower
Distribution
Part of a larger recall action
This product is one of 6 recalled by Smith & Nephew Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Smith & Nephew Inc.
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighSmith & Nephew Recalls Renasys Sterile Transparent Film Due to Seal Failures
FDA (Devices) · 2016-09-28
- ModerateSmith & Nephew Recalls RENASYS EZ Canisters Due to Deformed Inlet Ports
FDA (Devices) · 2014-10-15
- ModerateSmith & Nephew Recalls RENASYS EZ Wound Therapy Canisters
FDA (Devices) · 2014-10-15
- ModerateSmith & Nephew Recalls RENASYS EZ Negative Pressure Wound Therapy Systems
FDA (Devices) · 2014-10-01
- ModerateSmith & Nephew Recalls RENASYS EZ Canisters Due to Deformation
FDA (Devices) · 2014-10-15
- ModerateSmith & Nephew RENASYS GO Wound Therapy Recall for Clearance Issue
FDA (Devices) · 2017-01-25