RegWardenFDA facility compliance records
Company

SMITH AND NEPHEW MEDICAL LTD.

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

Recalls by year

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

Registered facilities (1)

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

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SMITH AND NEPHEW MEDICAL LTD. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9001952-smith-and-nephew-medical-ltd/

Not open yet

Alerts for SMITH AND NEPHEW MEDICAL LTD.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.