The Recall Desk

Manufacturer

Smith & Nephew Medical, Ltd.

3 recalls in our database name Smith & Nephew Medical, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2024-12-04

Of the 3 recalls from Smith & Nephew Medical, Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-0516-2025·2024-12-04

    RENASYS EDGE Pump Recall Due to Battery Charging Failure Risk

    Smith & Nephew recalls 1,589 RENASYS EDGE wound therapy pumps due to battery charging failure if not properly maintained. Affected patients may experience treatment interruption.

    Product
    RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1597-2024·2024-04-24

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1596-2024·2024-04-24

    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
    Medical Device
    Distribution
    Distributed nationwide