RegWardenFDA facility compliance records
Company

VENTLAB, LLC

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2014: 1 recalls; 2016: 1 recalls1’12’131’14’151’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2016-03-15
    Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an …
  • Class ITerminated2014-05-16
    The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
  • Class ITerminated2012-07-11
    Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

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. “VENTLAB, 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-2246980-ventlab-llc/

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