RENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk
Smith & Nephew is recalling RENASYS EDGE 800ML canisters due to black particulate matter from the carbon filter potentially damaging the NPWT pump. Affected patients should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves no reported injuries or illnesses. The source describes a theoretical hazard—particulate matter 'potentially causing' pump damage—rather than actual harm. Per the rubric, this qualifies as a risk-of-harm medical device where injury has not yet been reported, scoring High (3).
Plain-English summary
Smith & Nephew Medical, Ltd. is recalling RENASYS EDGE 800ML Canisters with Solidifier, used in negative pressure wound therapy (NPWT) to promote wound healing. The recall affects approximately 675 units distributed worldwide to patients and healthcare facilities in the United States, Canada, and Chile.
The canisters contain a defect in which black particulate matter from the carbon filter component may enter the NPWT pump and potentially cause damage. Damage to the pump could compromise the device's ability to function properly during wound care.
No injuries or illnesses have been reported. Patients who have used this product should contact their healthcare provider immediately. Healthcare providers should stop using the affected product and consult the FDA recall notice for return instructions.
The recalled product
- Product
- RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
- Manufacturer
- Smith & Nephew Medical, Ltd.
- Hazard
- device-damage
- particulate-matter
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)
- GTIN: (01)05000223501082 Lot Numbers: 1016051
- 1017549
Distribution
Distributed nationwide across the United States.
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