RegWardenFDA facility compliance records
Company

CSA MEDICAL, INC.

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

Recalls by year

FDA actions on record by year2014: 1 recalls; 2015: 1 recalls1’141’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2015-03-25
    TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax
  • Class IITerminated2014-11-10
    An increase in complaint trending for a loss of audible sound associated with the timer has been observed.

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. “CSA MEDICAL, 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-9062377-csa-medical-inc/

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