The Recall Desk

FDA (Devices) recall action 94248

Smith & Nephew Medical, Ltd. recalled 2 products on 2024-04-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-04-24
Critical
0
Units
7,570

Why these products were recalled

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2024-04-24

    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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-24

    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.

    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
    Category
    Distribution
    0 states