Food, drugs, devices › DeVilbiss Healthcare LLC
Device recall: DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
FDA enforcement event 91804 is a device recall by DeVilbiss Healthcare LLC of Somerset, PA, initiated 9 Mar 2023 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. 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
"The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard."
Distribution
"Worldwide - US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1558-2023 | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR | 143,397 units | Class II | Ongoing | 10 May 2023 |
Context
Other enforcement events for DeVilbiss Healthcare LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 13 May 2014 | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of pos | Device | Class III | 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: "The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.