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

FDA device recall Z-1035-2026 · posted 2026-01-08 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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.

Action taken

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

Status

Open, Classified

Product code

BYG

Quantity affected

1,611,081 eaches

Distribution

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

Date initiated

2025-11-21

Date posted

2026-01-08

Location

Northfield, IL