FDA Medical Device Recalls (openFDA)
Medical Industries America Inc: RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.
- Recall number
- Z-0326-05
- Recalling firm
- Medical Industries America Inc
- Product
- RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.
- Status
- Terminated
- Initiated
- 2004-09-03
- Posted
- 2004-12-17
- Terminated
- 2005-08-18
- Reason
- Units could show an error code and stop functioning.
- Root cause
- Other
- Action
- The recall was initiated via telephone on 9/3/04 to their customers explaining the reason for recall and instructing them to hold the units for further instruction. A telephone call to the customers on 9/10/04 instructed them to return the units for correction and replacement and to notify the end users.
- Quantity
- 74 units
- Distribution
- Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign distribution was made to Hong Kong, Chile, and Canada.
- Lot, serial or model codes
- All serial numbers beginning with C0424
- 510(k) numbers
- ["K002763"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 1931654
- Firm city
- Adel
- Firm state
- IA
- 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