FDA Device recall Z-1035-2026
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY by Medline Industries, citing 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 shortne….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1035-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-21 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | UDI: 1041CE 00888277446727 (ea) 40888277446725 (case); HUD1035 10197344011575 (ea) 20197344011572 (case); HUD1042 1…UDI: 1041CE 00888277446727 (ea) 40888277446725 (case); HUD1035 10197344011575 (ea) 20197344011572 (case); HUD1042 10197344011544 (ea) 20197344011541 (case); HUD1930 10197344009626 (ea) 20197344009623 (case); HUDRHO41U 10197344010646 (ea) 20197344010643 (case) Lots: 24DOA701 25EOA321 25EOA589 25EOA724 25EOA730 25EOA781 25EOA857 25FOA151 25FOA152 25FOA153 25FOA206 25FOA218 25FOA219 25FOA220 25FOA221 25FOA275 25FOA287 25FOA288 25FOA418 25FOA419 25FOA420 25FOA421 25FOA422 25FOA514 25FOA515 25FOA524 25FOA525 25FOA551 25FOA552 25FOA553 25FOA556 25FOA557 25FOA642 25FOA643 25FOA647 25FOA648 25FOA649 25FOA650 25FOA722 25FOA740 25FOA864 25FOA865 25FOA866 25GOA055 25GOA065 25GOA066 25GOA077 25GOA078 25GOA096 25GOA098 25GOA190 25GOA210 25GOA211 25GOA328 25GOA363 25GOA364 25GOA365 25GOA366 25GOA367 25GOA437 25GOA445 25GOA446 25GOA561 25GOA562 25GOA563 25GOA564 25GOA565 25GOA640 25GOA641 25GOA648 25GOA655 25GOA735 25GOA736 25GOA756 25GOA757 25GOA758 25GOA759 25GOA760 25GOA761 25GOA766 25GOA8 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1035-2026%22
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