Class III — DeVilbiss Healthcare LLC
| Recalling firm | Drive DeVilbiss Healthcare |
|---|---|
| Registered facility | DeVilbiss Healthcare LLC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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". |
| Product | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. |
| Quantity | 1809 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay. |
| Initiated | 2014-05-13 |
| Classified | 2014-07-01 |
| Terminated | 2014-12-02 |
| Recall number | Z-1949-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — DeVilbiss Healthcare LLC (Z-1949-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68393/
Alerts for Drive DeVilbiss Healthcare
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.