RegWardenFDA facility compliance records
Company

Smith & Nephew (Suzhou) Limited

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 3 recalls; 2016: 2 recalls1’133’14’152’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2016-11-11
    Lack of 510k clearance for design modification.
  • Class IIOngoing2016-07-21
    Sterility seal integrity failures on the Renasys Sterile Transparent Film
  • Class IITerminated2014-08-13
    Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
  • Class IITerminated2014-07-18
    RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
  • Class IITerminated2014-01-09
    Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contac…
  • Class IITerminated2013-11-14
    Modification of the bacterial overflow guard (filter) and related changes to product labeling.

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 & Nephew (Suzhou) Limited — 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-10034781-smith-nephew-suzhou-limited/

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