DeVilbiss Healthcare LLC: Medical Device Recall in 2022 - (Recall #: Z-0724-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

Product Classification:

Class II

Date Initiated: November 18, 2022

Date Posted: December 28, 2022

Recall Number: Z-0724-2023

Event ID: 91112

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 1004315 (US); 414559 (OUS)

Code Information:

Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots

Distribution Pattern:

US Nationwide. Foreign distribution pending.

Voluntary or Mandated:

Voluntary: Firm initiated