RegWardenFDA facility compliance records
Company

SOUTHMEDIC, INC.

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

Recalls by year

FDA actions on record by year2017: 2 recalls; 2021: 1 recalls; 2022: 1 recalls2201720182019202012021120222023202420252026
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2022-10-27
    Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.
  • Class IIOngoing2021-05-25
    Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
  • Class IITerminated2017-11-06
    Scalpels lot contains non-sterile products labeled as sterile.
  • Class IITerminated2017-10-17
    Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

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. “SOUTHMEDIC, INC. — 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-8022032-southmedic-inc/

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