DeVilbiss Healthcare recalls 525DS and 525DS-Q oxygen concentrators due to hot parts that may exceed 41°C (105.8°F) during use. Affected units include specific model numbers and lots.
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.
DeVilbiss is recalling two models of 5-liter oxygen concentrators because parts in contact with patients can become too hot. This risk could cause burns or discomfort if the device gets excessively hot during use.
The oxygen concentrator parts can become hot enough to exceed 41°C (105.8°F) in some situations. This temperature is higher than what is safe for skin contact, potentially causing burns or discomfort to patients.
Patients using the DeVilbiss 525DS or 525DS-Q oxygen concentrators are most at risk. These devices are typically used by individuals with breathing difficulties who rely on supplemental oxygen.
Check for model numbers 525DS or 525DS-Q on the device. Affected units include specific lot numbers: 00885304000846 for 525DS and 00885304009689 for 525DS-Q.
Feel the parts in contact with the patient to see if they are excessively hot. If so, stop using the device immediately.
Identify the model number on the device to confirm if it is affected (525DS or 525DS-Q).
The device may become hot due to normal operation, but the recall addresses cases where parts exceed 41°C (105.8°F) in some situations.
The recall does not specify a return or replacement process; users should check the device temperature and model numbers.
Check for model numbers 525DS or 525DS-Q and specific lot numbers: 00885304000846 for 525DS and 00885304009689 for 525DS-Q.
We’ve drafted a message you can send DeVilbiss to request your refund or repair — edit it as you like.
Subject: Recall Z-0724-2023 — DeVilbiss DeVilbiss Hello, I own a DeVilbiss that is covered by recall Z-0724-2023 from DeVilbiss. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.