Lower riskMedical device recall · FDA · Published June 18, 2018
Compass Health CPAP Mask Cushion Recall: Incompatibility Risk
Compass Health recalls CPAP mask cushions from model PB781S, PB781M, PB781L, 781S, 781M and 781L due to incompatibility between new cushion seals and old elbow designs, risking CO2 porting. Affected users should check their model numbers.
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.
Take action
Contact the company
📍Recalling firmCompass Health Brands (Corporate Office)6753 Engle Rd · Middleburg Heights, OH 44130-7934
✎ GovInfoNow plain-language explainer
Compass Health is recalling CPAP mask cushions with model numbers PB781S, PB781M, PB781L, 781S, 781M and 781L because a 2015 design change caused incompatibility between the cushion seal and elbow. This incompatibility could lead to CO2 porting, which may affect sleep apnea treatment. Read more at govinfonow.com/recall/70834-compass-health-cpap-mask-cushion-recall-incompatibility-risk.
“Compass Health CPAP Mask Cushion Recall: Incompatibility Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70834-compass-health-cpap-mask-cushion-recall-incompatibility-risk. Based on FDA recall #Z-2741-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2741-2018%22&limit=1).
The FDA announced on June 18, 2018, that Compass Health Brands is recalling CPAP Mask Cushions due to a design change causing incompatibility with previous elbow designs. The agency stated the recall was voluntary and initiated by the firm.
How to tell if you have it
Brand: Compass Health
Product: CPAP Mask Cushion
Model Nos.: PB781S, PB781M, PB781L, 781S, 781M and 781L
Manufactured after May 1, 2015
The hazard
A May 2015 design change in the cushion seal replacement part resulted in incompatibility with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting.
Context
GovInfoNow's records show Compass Health Brands has 3 other recalls on record since 2019-04-08. Other recent recalls of similar products include Bard PowerPICC Catheters (2026-05-21), Medline Oxygen Masks (2025-11-21) and Inspire Respiratory Sensing Lead Model 4340 (2026-05-11).
How to tell if you have this one
Check your CPAP mask cushion model number on the product. Affected models include PB781S, PB781M, PB781L, 781S, 781M and 781L. All units manufactured after May 1, 2015 are included in this recall.
Brand
Compass Health
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for the model number on your CPAP mask cushion to confirm if it is one of the affected models: PB781S, PB781M, PB781L, 781S, 781M or 781L.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Connecticut, Florida, Georgia, Kentucky, Mississippi, New York, North Carolina, Tennessee, Texas.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
CO2 porting refers to the CPAP machine not functioning properly, which could disrupt sleep apnea treatment by allowing carbon dioxide to build up in the user's system.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2741-2018 (June 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2741-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.