DeVilbiss Model DV5x Series CPAP units — Class III medical device recall Z-1949-2014
Terminated recall by DeVilbiss Healthcare LLC, reported 2014-07-09, distributed nationwide. A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed
| Recall number | Z-1949-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeVilbiss Healthcare LLC, Somerset, PA, United States |
| Recall initiated | 2014-05-13 |
| Classified | 2014-07-01 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2014-12-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO, HN, IR, TH, UY |
| Quantity | 1,809 |
| Serial numbers | HD066549, HD066566, HD069264, HD069679, HD069680, HD069681, HD069682, HD069683, HD069684, HD069685, HD069686, HD069687, HD069688, HD069689, HD069690, HD069691, HD069692, HD069693, HD069694, HD069695, HD069696, HD069697, HD069698, HD069699, HD069700 and 475 more |
| Model numbers | DV51D-HH, DV53D-HH, DV53D-HH-S, DV54D-HH, DV54D-HH-S, DV55D-HH, DV55D-HH-S, DV55D-S, DV57D-HH, DV5X |
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.
Reason for recall
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".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1949-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.