RegWardenFDA facility compliance records
Company

Drive DeVilbiss Healthcare

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2016: 1 recalls; 2022: 2 recalls; 2023: 1 recalls1’131’14’151’16’17’18’19’20’212’221’23’24’25’26
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-03-09
    The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
  • Class IIOngoing2022-11-18
    The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life…
  • Class IIOngoing2022-09-19
    An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
  • Class IITerminated2016-05-23
    A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
  • Class IIITerminated2014-05-13
    A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".
  • Class IITerminated2013-03-07
    End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.

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. “Drive DeVilbiss Healthcare — 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-10032050-drive-devilbiss-healthcare/

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