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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Oxygen Masks
- Model numbers
- 1041CE, HUD1035, HUD1042, HUD1930, HUDRHO41U
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 21, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the model number on your oxygen mask packaging or device.
- Verify if the model is listed in the recall announcement.
- 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.
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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
- Class II recall
- Stop using the device immediately
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Safety Guide
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