Medline Industries, LP recalls Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED…

Recall date

November 21, 2025

Source

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

Recall number

Z-1035-2026

FDA classification

Class II

Brand / firm

Medline Industries, LP

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.

Why it was recalled

Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.

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

What was recalled

Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC