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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

SleepNet Corporation: CPAP and Nasal Masks Recalled for Updated Magnetic Interference Warnings

Agency Publication Date: April 1, 2024
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Summary

SleepNet Corporation is recalling 45,972 CPAP and nasal masks, including the Mojo, Mojo 2, iQ 2, and Phantom 2 models, to update safety warnings and contraindications. These masks contain magnets that can interfere with certain implanted medical devices, such as pacemakers or brain shunts. This voluntary recall was initiated to ensure users are aware of the risks when using these masks near metallic implants or devices sensitive to magnetic fields.

Risk

The magnets used in these masks can potentially cause implanted medical devices to malfunction or shift if they are within close proximity. This magnetic interference could lead to serious health complications or the failure of life-saving equipment like implanted defibrillators or neurostimulators.

What You Should Do

  1. Identify if you have one of the affected masks: Mojo Full Face (Vented/Non-Vented), Mojo 2 Full Face (Vented/Non-Vented/AAV), iQ 2 Nasal Vented, or Phantom 2 Nasal Vented mask.
  2. Check your mask for the presence of magnetic clips used to secure the headgear to the mask frame.
  3. Consult with your healthcare provider if you or anyone in close physical contact with you (such as a bed partner) has an implanted medical device like a pacemaker, defibrillator, or metallic stent.
  4. Review the updated contraindications and warning language provided by SleepNet regarding the safe distance to maintain between the mask magnets and implanted devices.
  5. Contact your healthcare provider or SleepNet Corporation for further instructions and to discuss any concerns regarding the continued use of these masks.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Safety labeling update

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Mojo Full Face with Headgear, All Sizes
Model / REF:
Z-1351-2024
Lot Numbers:
All Lot Numbers
Product: Mojo Non Vented Full Face Mask with Headgear, All Sizes
Model / REF:
Z-1352-2024
Lot Numbers:
All Lot Numbers
Product: Mojo 2 Full Face Vented Mask, All Sizes
Model / REF:
Z-1353-2024
Lot Numbers:
All Lot Numbers
Product: Mojo 2 Full Face Non Vented Mask, All Sizes
Model / REF:
Z-1354-2024
Lot Numbers:
All Lot Numbers
Product: Mojo 2 Full Face AAV Non Vented Mask, All Sizes
Model / REF:
Z-1355-2024
Lot Numbers:
All Lot Numbers
Product: iQ 2 Nasal Vented Mask
Model / REF:
Z-1356-2024
Lot Numbers:
All Lot Numbers
Product: Phantom 2 Nasal Vented Mask
Model / REF:
Z-1357-2024
Lot Numbers:
All Lot Numbers

Product Images

Image of Phantom 2 Nasal Mask

Image of Phantom 2 Nasal Mask

Image of iQ 2 Nasal Mask

Image of iQ 2 Nasal Mask

Image of Mojo Full Face Vented Mask and Mojo Full Face Non Vented Mask

Image of Mojo Full Face Vented Mask and Mojo Full Face Non Vented Mask

Image of Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non Vented Mask, and Mojo 2 Full Face AAV Non Vented Mask

Image of Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non Vented Mask, and Mojo 2 Full Face AAV Non Vented Mask

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94169
Status: Active
Manufacturer: SleepNet Corporation
Sold By: Authorized medical equipment distributors
Manufactured In: United States
Units Affected: 7 products (23,042 units; 11,874 units; 2,787 units; 2,107 units; 1,268 units; 2477 units; 2417 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.