Recall Z-1035-2026 ยท BYG Mask, Oxygen
Medline Industries, LP
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
| Date | Jan 8, 2026 (initiated Nov 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.