# FDA recall Z-1035-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-11-21.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Bahamas, Canada, China, Dominican Republic, Guam, South Korea, Mexico, Panama, and Singapore.

## Key facts

- **Recall number:** Z-1035-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-21
- **Report date:** 2026-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1035-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1035-2026. Source: US FDA. Licensed CC0.

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