DeVilbiss recall
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Why was DeVilbiss recalled?
The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
- Product
- DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
- Recalling firm
- DeVilbiss Healthcare LLC
- Quantity
- 1004315 (US); 414559 (OUS)
- Distribution
- US Nationwide. Foreign distribution pending.
- Recall date
- December 28, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)