The Recall Desk
ModerateFDA (Devices)·Z-0041-2015·Announced 2014-10-15

Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformed Inlet Ports

Smith & Nephew is recalling RENASYS EZ and EZ Plus 800 mL canisters with deformed inlet ports on the lid. The defect may affect the collection of wound exudate during negative pressure wound therapy.

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 classified as FDA Class II. The source text describes a physical defect (deformation) without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential for temporary or reversible health consequences.

Plain-English summary

Smith & Nephew, Inc. is recalling 45,466 units of RENASYS EZ and RENASYS EZ Plus 800 mL canisters (without CLP) with Solidifier. The recall is due to visible evidence of deformation of the inlet port on the canister lid. These canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

The affected product is Item 66800912, Lot # M400071. The units were distributed worldwide, including nationwide in the United States and in various international locations such as Canada, Mexico, and several countries in Europe, Asia, and the Middle East.

Consumers and healthcare providers should stop using the affected canisters and contact Smith & Nephew for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Wound Care
Hazard
Affected units
45,466

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)

  • Item 66800912 Lot # M400071

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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