DeVilbiss Healthcare LLC recalls DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

Recall date

March 9, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1558-2023

FDA classification

Class II

Brand / firm

DeVilbiss Healthcare LLC

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR