Smith & Nephew Recalls RENASYS EZ Negative Pressure Wound Therapy Systems
Smith & Nephew is recalling RENASYS EZ Negative Pressure Wound Therapy Systems because modifications were made without required FDA notifications.
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 does not report any illnesses, injuries, or specific physical hazards, indicating a regulatory compliance issue rather than a direct safety threat.
Plain-English summary
Smith & Nephew, Inc. is recalling 2,142 units of the RENASYS EZ Negative Pressure Wound Therapy (NPWT) System. The recall affects Model #66800059, all lots since the product launched on January 16, 2009.
The recall was initiated because modifications were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification to the FDA. The product is distributed worldwide, including the United States (nationwide), Canada, Mexico, and various international locations.
Consumers and healthcare providers should stop using the affected devices and contact Smith & Nephew for further instructions.
The recalled product
- Product
- RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Wound Care
- Affected units
- 2,142
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 #'s 66800059
- all lots since product launched 01/16/2009
Distribution
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