RegWardenFDA facility compliance records
Company

Draeger, Inc.

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

Recalls by year

FDA actions on record by year2025: 5 recalls; 2026: 1 recalls201720182019202020212022202320245202512026
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2026-05-07
    The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
  • Class IOngoing2025-11-24
    A certain component of affected devices was not delivered within specification and contained impurities.
  • Class IOngoing2025-11-10
    Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
  • Class IOngoing2025-09-09
    The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
  • Class IOngoing2025-06-16
    Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
  • Class IOngoing2025-03-12
    The potential for cracks forming in the breathing circuit hose.

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. “Draeger, 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-10052404-draeger-inc/

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