FDA Medical Device Recalls (openFDA)
DeVilbiss Healthcare LLC: DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
- Recall number
- Z-0724-2023
- Recalling firm
- DeVilbiss Healthcare LLC
- Product
- DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
- Status
- Open, Classified
- Initiated
- 2022-11-18
- Posted
- 2022-12-19
- Terminated
- not on file
- Reason
- 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
- 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
- 1004315 (US); 414559 (OUS)
- Distribution
- US Nationwide. Foreign distribution pending.
- Lot, serial or model codes
- Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
- 510(k) numbers
- ["K071397"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 2515872
- Firm city
- Somerset
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28