The Recall Desk
HighFDA (Devices)·Z-2741-2018·Announced 2018-08-29

Compass Health Brands Recalls CPAP Mask Cushions Due to Design Incompatibility

Compass Health Brands is recalling CPAP mask cushions because a design change makes them incompatible with previous elbow parts, potentially causing unacceptable CO2 porting.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where the hazard (unacceptable CO2 porting) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Compass Health Brands is recalling 742 units of CPAP Mask Cushions, including Model Nos. PB781S, PB781M, PB781L, 781S, 781M, and 781L. These cushions are non-durable components used to provide a seal between the user's face and the CPAP mask for the treatment of sleep apnea. The affected units were distributed nationwide to Alabama, Connecticut, Florida, Georgia, Kentucky, Mississippi, North Carolina, New York, Tennessee, and Texas.

The recall is due to a design change implemented in May 2015 for the cushion seal and accompanying elbow replacement part. This change resulted in incompatibility between the new cushion seal and the previous design of the elbow. Using the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. Because the model number did not change with this design update, customers may not be aware of the incompatibility.

All affected units were manufactured after May 1, 2015. Consumers should stop using the affected cushions and contact the recalling firm for further instructions.

The recalled product

Product
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
Manufacturer
Compass Health Brands (Corporate Office)
Category
Medical Device — CPAP Components
Hazard
Affected units
742

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All units manufactured after May 1
  • 2015

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Related recalls

Same manufacturer · Compass Health Brands (Corporate Office)

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