Smith & Nephew Recalls Renasys EZ Canisters for Labeling and Filter Changes
Smith & Nephew is recalling Renasys EZ canisters to modify the bacterial overflow guard and update product labeling.
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 involves labeling changes and a component modification without reported injuries or illnesses, fitting the criteria for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Smith & Nephew Inc. is recalling 6,799,140 units of the Renasys EZ canister, a component of the Renasys EZ Negative Pressure Wound Therapy System. The recall covers specific product codes and lot codes ranging from M201498 to M400299.
The recall is being conducted to modify the bacterial overflow guard (filter) and to make related changes to the product labeling. The affected canisters were distributed worldwide, including nationwide in the United States and in numerous international countries.
Consumers and healthcare providers should stop using the affected canisters and contact Smith & Nephew for instructions on how to proceed with the modification and labeling updates.
The recalled product
- Product
- Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
- Manufacturer
- Smith & Nephew Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 6,799,140
Distribution
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.
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