Reported Dec 28, 2022 · Ongoing
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
DeVilbiss Healthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeVilbiss Healthcare LLC · 100 Devilbiss Dr · Somerset, PA · 15501-2125
Is this the product you have?
DeVilbiss525 5-liter Oxygen Concentrator Models 525DS525DS-Q
- Lot codes and dates
- Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
- Amount recalled
- 1004315 (US); 414559 (OUS)
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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