The Recall Desk

Manufacturer

DeVilbiss Healthcare LLC

6 recalls in our database name DeVilbiss Healthcare LLC as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2023-05-10

Of the 6 recalls from DeVilbiss Healthcare LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • ModerateFDA (Devices)·Z-1558-2023·2023-05-10

    DeVilbiss Healthcare 1025 Series Oxygen Concentrator Instruction Manual Update

    DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.

    Product
    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2023·2022-12-28

    DeVilbiss 525 Oxygen Concentrator Recalled Due to Excessive Heat

    DeVilbiss is recalling the 525 oxygen concentrator because the device can become excessively hot, with external parts potentially exceeding 105.8 degrees Fahrenheit. The firm has updated the user manual to include additional safety warnings.

    Product
    DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2023·2022-11-23

    125 Series iGO2 Portable Oxygen Concentrator Recalled for Unapproved Adhesive

    DeVilbiss is recalling 125 series iGO2 oxygen concentrators due to an unapproved adhesive in the accumulator tank, which is part of the oxygen delivery system. Affected units were distributed in eight U.S. states and Canada.

    Product
    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-1949-2014·2014-07-09

    DeVilbiss DV5x Series CPAP Units Recalled for Missing Serial Numbers

    DeVilbiss Healthcare LLC is recalling 1,809 DV5x Series CPAP units because they were shipped without programmed serial numbers, displaying 'RUN-TEST' on the screen.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2013·2013-10-09

    DeVilbiss Disposable Suction Container Filter Recall Due to Fluid Exposure

    DeVilbiss Healthcare LLC is recalling specific Disposable Suction Container/Filter units because fluid exposure can occlude the bacterial filter, rendering it unusable.

    Product
    DeVilbiss 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 Contain
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

DeVilbiss Healthcare (United States)

company in Somerset, United States

Country
United States
Founded
1888

Official website

Source: Wikidata (Q106411882), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.