RegWardenFDA facility compliance records
Company

Engineered Medical Systems, LLC

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

Recalls by year

FDA actions on record by year2011: 1 recalls1’11’12’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class ITerminated2011-09-12
    The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

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. “Engineered Medical Systems, 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-10042524-engineered-medical-systems-llc/

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