Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
CPAP Mask Cushion Recalled by Compass Health Brands (Corporate Office) Due to A May 2015 design change in the cushion...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Compass Health Brands (Corporate Office) directly.
Affected Products
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.
Quantity: 742
Why Was This Recalled?
A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. As there was no model number change for this design change, customers may not be aware of the incompatibility.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Compass Health Brands (Corporate Office)
Compass Health Brands (Corporate Office) has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report