Recall Register

Food, drugs, devices › Firms

DeVilbiss Healthcare LLC

FDA recalling firm · 6 enforcement events · 6 product records · 2013–2023 · PA

DeVilbiss Healthcare LLC has 6 FDA enforcement events on this register (6 product records) between 2013 and 2023: 6 device; the busiest year was 2022 with 2.

0% of its events are Class I; the most common class is Class II (5). 3 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
9 Mar 2023DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-ARDeviceClass II1Ongoing
18 Nov 2022DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-QDeviceClass II1Ongoing
19 Sep 2022125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XBDeviceClass II1Ongoing
23 May 2016DeVilbiss Model 7305P-D Powered Suction UnitDeviceClass II1Terminated
13 May 2014DeVilbiss 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.DeviceClass III1Terminated
7 Mar 2013DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from…DeviceClass II1Terminated

By type and class

Device6
Class II5
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for DeVilbiss Healthcare LLC by year initiated.

Questions and answers

How many FDA recalls has DeVilbiss Healthcare LLC had?

6 enforcement events (6 product records) on this register, 2013–2023: 6 device.

Are any DeVilbiss Healthcare LLC recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are DeVilbiss Healthcare LLC recalls?

5 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.