FDA Medical Device Recalls (openFDA)
Sunrise Medical: DeVilbiss iFill Personal Oxygen Station model number 535D.
- Recall number
- Z-0038-2007
- Recalling firm
- Sunrise Medical
- Product
- DeVilbiss iFill Personal Oxygen Station model number 535D.
- Status
- Terminated
- Initiated
- 2006-08-24
- Posted
- 2006-10-17
- Terminated
- 2009-08-27
- Reason
- Potential for oxygen cylinders to not fill completely
- Root cause
- Other
- Action
- The recalling firm began to notify customers via telephone beginning on 8/24/06. An 'Urgent Medical Device Recall' letter was sent on 8/28/06. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. A customer service help line has been established (1-800-333-4000) to provide additional information for returning units.
- Quantity
- 252 units
- Distribution
- The product was distriubted to 252 end users nationwide through 36 dealers.
- Lot, serial or model codes
- serial numbers AD01145 through AD01462
- 510(k) numbers
- ["K053240"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 2515872
- Firm city
- Somerset
- 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