NPWT Canister Recalled Due to Carbon Filter Contamination Risk
Smith & Nephew is recalling RENASYS EDGE 300ML canisters due to black particulate matter from the carbon filter that may enter the pump. The recall affects 6,895 units distributed in the US, Canada, and Chile.
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: This FDA Class II recall involves potential damage to medical device pumps from particulate contamination. The hazard is theoretical in nature, and the contamination risk is relatively low compared to biological pathogens, supporting a Moderate severity classification.
Plain-English summary
Smith & Nephew Medical, Ltd. is recalling RENASYS EDGE 300ML canisters with solidifier (Product Number 66803139). These canisters are components of negative pressure wound therapy (NPWT) pumps indicated for patients who may benefit from suction therapy to promote wound healing.
The recall was initiated because black particulate matter from the carbon filter component may enter the NPWT pump and potentially cause damage to the pump.
Approximately 6,895 units have been distributed worldwide, including throughout the United States, Canada, and Chile. The affected lot numbers are 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, and 1016044.
The recalled product
- Product
- RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
- Manufacturer
- Smith & Nephew Medical, Ltd.
- Affected units
- 6,895
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 (9)
- GTIN: (01)05000223501044 Lot Numbers: 1016448
- 1016478
- 1016537
- 1016773
- 1017147
- 1017417
- 1017418
- 1017912
- 1016044
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew Medical, Ltd. 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 2 products in this recall →Related recalls
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