CLASS I Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
CPAP Mask Cushion recalled by Compass Health Brands
Compass Health Brands (Corporate Office) is recalling CPAP Mask Cushion, distributed nationwide in the US. The recall was initiated on 18 Jun 2018 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2741-2018
- FDA event ID
- 80545
- Recalling firm
- Compass Health Brands (Corporate Office), Middleburg Heights, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Jun 2018
- FDA classified
- 20 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- CPAP & Ventilators
Timeline
| 18 Jun 2018 | Recall initiated by company | |
| 20 Aug 2018 | Classified by FDA | +63 days |
| 29 Aug 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.
Nationwide AlabamaConnecticutFloridaGeorgiaKentuckyMississippiNorth CarolinaNew YorkTennesseeTexas
Questions about this recall
Is CPAP Mask Cushion recalled?
Yes. Compass Health Brands (Corporate Office) recalled CPAP Mask Cushion on 18 Jun 2018. The recall is Class I and its status is Terminated. Recall number Z-2741-2018.
Why was it 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.
Which lots are affected?
All units manufactured after May 1, 2015
Where was it sold?
US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Compass Health Brands (Corporate Office)
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REX (Recovery Exercise X-Trainer) Pressure Therapy System recalled | Compass Health Brands (Corporate Office) | Other | Nationwide |
| Device | CLASS II | Voyager Rollator-intended as a mechanical walker recalled | Compass Health Brands (Corporate Office) | Device Malfunction | Nationwide |
| Device | CLASS II | MediPress pneumatic compression system Full Arm recalled | Compass Health Brands (Corporate Office) | Other | Nationwide |
| Device | CLASS II | MediPress pneumatic compression system Full Arm recalled | Compass Health Brands (Corporate Office) | Other | Nationwide |
| Device | CLASS II | MediPress pneumatic compression system Full Leg recalled | Compass Health Brands (Corporate Office) | Other | Nationwide |
Other CPAP & Ventilators recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |