RegWardenFDA facility compliance records
Company

Mercury Medical Enterprises, LLC

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2024: 2 recalls12015201620172018201920202021202220232202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2024-12-10
    Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation …
  • Class IOngoing2024-08-30
    Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
  • Class IITerminated2015-10-22
    Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.

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. “Mercury Medical Enterprises, LLC — 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-1024404-mercury-medical-enterprises-llc/

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