The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1041-2017·Announced 2017-01-25

Smith & Nephew RENASYS GO Wound Therapy Recall for Clearance Issue

Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy devices 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 classified as FDA Class II, but the source text identifies the issue as a regulatory documentation deficiency (lack of 510(k) clearance) rather than a direct physical hazard or reported injury, aligning with the 'Moderate' criteria for minor labeling/documentation errors.

Plain-English summary

Smith & Nephew, Inc. is recalling RENASYS GO Negative Pressure Wound Therapy devices. The recall is due to a lack of 510(k) clearance for a design modification. The affected product is a prescription-only suction device intended to promote wound healing by removing fluids, including irrigation, 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.

Approximately 15,960 units of Model No. 66800164 are affected in the United States. The recall is nationwide. All pumps of this model are affected. The agency classification for this recall is Class II.

Consumers and healthcare providers should stop using the affected devices and contact Smith & Nephew, Inc. for further instructions or a replacement.

The recalled product

Product
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, 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 materials. Used for…
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 (2)

  • Model No. 66800164
  • All pumps of this model are affected.

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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