Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1035-2026 — 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

U.S. FDA — Device Enforcement · United States · 2025-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1035-2026
Date of alert
2025-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medline Industries, LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00888277446727
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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