Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK — Class II medical device recall Z-1035-2026
Ongoing recall by Medline Industries, LP, reported 2026-01-14, distributed nationwide. Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use,
| Recall number | Z-1035-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-11-21 |
| Classified | 2026-01-08 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BS, CA, CN, DO, KR, MX, PA, SG |
| Quantity | 1,611,081 eaches |
| UPC / GTIN / UDI-DI | 00888277446727, 10197344009626, 10197344010646, 10197344011544, 10197344011575, 20197344009623, 20197344010643, 20197344011541, 20197344011572, 40888277446725 |
| Lot numbers | 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 and 184 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1035-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.