The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1042-2017·Announced 2017-01-25

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.

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 2/5 (Moderate).

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
Hazard
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 →

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