Open, Classified

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

FDA Recall Z-1035-2026 · Posted 2026-01-08

Recall StatusOpen, Classified

Product CodeBYG

Date Initiated2025-11-21

Product Quantity1,611,081 eaches

Reason for Recall

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.

Firm Action

On November 21, 2025, the firm notified customers via Urgent Medical Device Recall letter. Customers were instructed to destroy affected product on hand. No product is being returned to Medline. For kits, Medline instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.