FDA Medical Device Recalls (openFDA)
Respironics, Inc.: ComfortGel Nasal Mask size medium
- Recall number
- Z-0179-04
- Recalling firm
- Respironics, Inc.
- Product
- ComfortGel Nasal Mask size medium
- Status
- Terminated
- Initiated
- 2003-09-29
- Posted
- 2003-12-10
- Terminated
- 2004-03-01
- Reason
- product does not contain built in exhalation port
- Root cause
- Other
- Action
- The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.
- Quantity
- 5293 units
- Distribution
- The products were shipped to sleep centers nationwide and in Canada.
- Lot, serial or model codes
- Part number 1009042; Lot numbers 030604, 030603, 030528, 030520, 030501, 030422, 030421, 030408, 030325, 030319, 030314, 030312, 030311, 030227, 030226, 020826, and 020823.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28