The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0039-2015·Announced 2014-10-15

Smith & Nephew Recalls RENASYS EZ Wound Therapy Canisters

Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters due to visible deformation of the inlet port on the canister lid.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving a defect without reported harm.

Plain-English summary

Smith & Nephew, Inc. is recalling 19,499 units of RENASYS EZ and RENASYS EZ Plus 250 mL canisters with Solidifier. These medical devices are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). The recall involves Item 66800058 (Lot # M400021) and Item 66800913 (Lot # M400067).

The recall was initiated because the canisters exhibit visible evidence of deformation of the inlet port on the canister lid. The affected units were distributed worldwide, including nationwide in the United States and in various international locations such as Canada, Mexico, and Germany.

Healthcare providers and consumers should stop using the affected canisters and contact Smith & Nephew for further instructions. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product
RENASYS EZ/ RENASYS EZ Plus 250 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 66800058 Lot # M400021 & Item 66800913 Lot # M400067

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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