CPAP Mask Cushion — Class I medical device recall Z-2741-2018
Terminated recall by Compass Health Brands (Corporate Office), reported 2018-08-29, distributed nationwide. A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted
| Recall number | Z-2741-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Compass Health Brands (Corporate Office), Middleburg Heights, OH, United States |
| Recall initiated | 2018-06-18 |
| Classified | 2018-08-20 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2020-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 742 |
| Reason classes | packaging |
| Model numbers | 781L, 781M, 781S, PB781L, PB781M, PB781S |
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 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2741-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.