Food, drugs, devices › DeVilbiss Healthcare LLC
Device recall: DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of pos
DeVilbiss Healthcare LLC (Somerset, PA) initiated this device recall on 13 May 2014; FDA lists 1 product record under event 68393, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 2 Dec 2014. Initiation: voluntary: firm initiated. DeVilbiss Healthcare LLC has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DeVilbiss Healthcare LLC, Somerset, PA.
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"."
Distribution
"Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1949-2014 | 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. | 1809 | Class III | Terminated | 9 Jul 2014 |
Context
Other enforcement events for DeVilbiss Healthcare LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Mar 2023 | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR | Device | Class II | 1 |
| 18 Nov 2022 | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | Device | Class II | 1 |
| 19 Sep 2022 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D | Device | Class II | 1 |
| 23 May 2016 | DeVilbiss Model 7305P-D Powered Suction Unit | Device | Class II | 1 |
| 7 Mar 2013 | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML D | Device | Class II | 1 |
All 6 events for DeVilbiss Healthcare LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Dec 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.