Z-0724-2023Class II

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

Name: Z-0724-2023 DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Creator: DeVilbiss Healthcare LLC
Published: 2022-11-18
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2022-11-18 / Open, Classified / root cause: labeling and UDI

FDA source

DeVilbiss Healthcare LLC began a recall of DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q on 2022-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0724-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-18
Posted: 2022-12-19
Recalling firm: Sunrise Medical, Inc.
Product: DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Product code: CAW Generator, Oxygen, Portable
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On November 18, 2022, the firm notified customers through Urgent Notice Medical Device Correction letters/emails. The firm is updating its instruction manual to include the following: " warnings related to applied parts that may come into contact with a patient that, when under single fault failure conditions while operating at maximum environmental temperatures, could cause the surface temperature of the part to exceed 41C; " clarifications regarding the expected service life for the unit; and " additional instructions regarding wear components that may require maintenance during the expected service life of the product. Customers may navigate to www.recallrtr.com/525series to obtain copies of the updated instruction manual. The firm may be reached at 1 (833) 408-0512, from 8:00 am to 7:00 pm EST Monday through Friday.
Quantity in commerce: 1004315 (US); 414559 (OUS)
Distribution: US Nationwide. Foreign distribution pending.
Product codes and lots: Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0724-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0724-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-19

Product code CAW

K071397Class IIDevilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesSunrise Medical / cleared 2007-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)