RegWardenFDA facility compliance records
Facility

Smith & Nephew Medical Ltd

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2024: 2 recalls20172018201920202021202220232202420252026
  • Recalls (2)

Devices registered here (1)

  • Bag, Drainage, With Adhesive, Ostomy
    Product code FON (opens in a new tab) · Class I · Gastroenterology, Urology · 21 CFR 876.5900

Recalls & enforcement

  • Class IIOngoing2024-10-02
    Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
  • Class IIOngoing2024-03-11
    Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Smith & Nephew Medical Ltd (FEI 3002808194) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808194-smith-nephew-medical-ltd/

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