DeVilbiss iFill Personal Oxygen Station model number 535D recallZ-0038-2007 · Sunrise Medical · initiated Aug 24, 2006
Terminated All recalls posted in October 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sunrise Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for oxygen cylinders to not fill completely
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0038-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 24, 2006
- Posted by the FDA
- Oct 17, 2006
- Recalling firm
- Sunrise Medical
- Quantity
- 252 units
- Product code
- CAW
- FDA submissions
- K053240
- Distribution
- The product was distriubted to 252 end users nationwide through 36 dealers.
Product description
DeVilbiss iFill Personal Oxygen Station model number 535D.
Code information (models, lots, serial numbers)
serial numbers AD01145 through AD01462
Other devices under the same FDA submission
2 devices cleared under K053240 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DeVilbiss iFill 535IDevilbiss Healthcare LLC · Generator, Oxygen, Portable1 report
- DeVilbiss 535C-D-870Devilbiss Healthcare LLC · Generator, Oxygen, Portable1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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