HIGH

Medline Recalls Oxygen Masks Due to Tubing Disconnect Risk

Medline Industries recalled over 1.6 million oxygen masks on November 21, 2025. The recall affects multiple models after reports of tubing disconnecting during use. This defect can delay patient care and lead to shortness of breath, requiring medical intervention.

Quick Facts at a Glance

Recall Date
November 21, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

Medline Hudson RCI Medium Concentration Oxygen Masks are used to supply oxygen to patients requiring respiratory support. They are essential in medical settings, especially for patients with breathing difficulties.

Why This Is Dangerous

The hazard arises when the tubing disconnects from the mask, leading to a potential lack of oxygen supply. This can result in a patient's shortness of breath and hypoxia, which can be life-threatening without immediate intervention.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The immediate impact of this recall means that healthcare facilities and patients using these masks face potential delays in respiratory care, which can be critical in emergency situations.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on your oxygen mask packaging or device.
  2. Verify if the model is listed in the recall announcement.
  3. Look for any additional identifiers that may link the product to the recall.

Where to find product info

Model numbers can typically be found on the packaging or printed on the device itself.

What timeline to expect

Refund processing may take 4-6 weeks after the returned product is received by Medline.

If the manufacturer is unresponsive

  • Contact Medline Industries again through their customer support.
  • Document your attempts to reach out for further action if needed.
  • Consider reaching out to regulatory bodies if issues persist.

How to prevent similar issues

  • Always check for recalls on medical devices before purchase.
  • Look for products with safety certifications from recognized authorities.
  • Consult healthcare professionals for device recommendations.

Documentation advice

Keep a record of your purchase, any correspondence with the manufacturer, and photographs of the product.

Product Details

The recall affects 1,611,081 units of Medline Hudson RCI Medium Concentration Oxygen Masks. Models include 1041CE, HUD1035, HUD1042, HUD1930, and HUDRHO41U. These products were distributed worldwide, including the U.S., Australia, Canada, and several other countries.

Key Facts

  • Recall date: November 21, 2025
  • Distribution: Worldwide
  • Class II recall
  • Stop using the device immediately
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeOxygen Masks
Sold At
Multiple Retailers

Product Details

Model Numbers
1041CE
HUD1035
HUD1042
HUD1930
HUDRHO41U
Affected States
ALL
Report Date
January 14, 2026
Recall Status
ACTIVE

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