Smith & Nephew RENASYS GO Power Supply Recalled for Regulatory Clearance
Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy External Power Supply Units because they lack 510(k) clearance for a design modification.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is due to a regulatory documentation issue (lack of 510(k) clearance) rather than a direct safety hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling the RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit. The recall involves 15,960 units distributed nationwide. The affected units are identified by Model No. 66800161 when sold separately, or Model No. 66800164 when sold with the RENASYS GO NPWT Pump, and have a Serial Number less than 144500875.
The reason for the recall is a lack of 510(k) clearance for a design modification. The product is intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates, and infectious materials. It is used for chronic, acute, traumatic, subacute, and dehisced wounds, ulcers, partial thickness burns, flaps, and grafts.
Consumers and healthcare providers should stop using the affected units and contact Smith & Nephew for further instructions.
The recalled product
- Product
- Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 15,960
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 (3)
- Model No. 66800161 when sold separately
- Model No. 66800164 when sold with RENASYS GO NPWT Pump
- Serial No. < than 144500875.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 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 · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01