RegWardenFDA facility compliance records
Company

SOUTHWEST TECHNOLOGIES, INC.

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2019: 1 recalls; 2021: 1 recalls1201720181201920201202120222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2021-05-28
    Dose audit failure after sterilization process
  • Class IITerminated2019-11-18
    Elasto-Gel Wound Dressing may be contaminated with mold.
  • Class IIOngoing2017-12-28
    Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments. Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.

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. “SOUTHWEST TECHNOLOGIES, 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-1929833-southwest-technologies-inc/

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