The Recall Desk
ModerateFDA (Devices)·Z-0040-2015·Announced 2014-10-15

Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformation

Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters because the inlet port on the lid may be deformed.

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, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a theoretical risk of harm rather than a confirmed adverse event.

Plain-English summary

Smith & Nephew, Inc. is recalling RENASYS EZ and RENASYS EZ Plus 800 mL canisters with Solidifier. These medical devices are used to collect exudate from wounds treated with negative pressure wound therapy (NPWT). The recall is due to visible evidence of deformation of the inlet port on the canister lid.

The recall involves 77,164 units, specifically Item 66800423 (Lot # M400058) and Item 66801066 (Lot # M400124). The products were distributed worldwide, including in the United States, Canada, Mexico, and various other countries. The FDA has classified this as a Class II recall.

Consumers and healthcare providers should stop using the affected canisters and contact Smith & Nephew for instructions on how to return or replace the products.

The recalled product

Product
RENASYS EZ/ RENASYS EZ Plus 800 mL canister 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

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 66800423 Lot # M400058 & Item 66801066 Lot # M400124

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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