FDA-Device2026-01-14Class IIPROCESSING DEFECT

Medline Hudson RCI Medium Concentration Oxygen Masks recalled for tubing disconnection hazard

OTHERNationwide distribution

Stop using Medline Hudson RCI oxygen masks

Medline Industries is recalling multiple models of Hudson RCI oxygen masks because the tubing can disconnect during use. If this happens, oxygen delivery stops, which can delay patient care and cause breathing problems that may require medical intervention.

  • Check if you have any of the affected oxygen mask models listed in the recall (1041CE, HUD1035, HUD1042, HUD1930, or HUDRHO41U)
  • Verify the lot number on the packaging matches the affected lots (beginning with 24DOA, 25EOA, 25FOA, 25GOA, 25HOA, 25IOA, 25JOA, or 25KOA)
  • Stop using the mask immediately if you have an affected lot
  • Contact Medline Industries or your healthcare provider for a replacement or instructions
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.
Affected count
1,611,081 eaches
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1035-2026

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