DeVilbiss Healthcare LLC DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Brand
DeVilbiss Healthcare LLC
Lot Codes / Batch Numbers
Model 1025DS - UDI-DI: 00885304000846, Serial Numbers A175230001DS to A232160185DS, Model 1025UK - UDI-DI: 00885304022480, Serial Numbers A179210001US to A232060432US, Model 1025KS - UDI-DI: 00853040224734, Serial Numbers A176060001KS to A232220085KS, Model 1025KS-AR - UDI-DI: 00853040224734, Serial Numbers A216240003KS to A229210010KR
Products Sold
Model 1025DS - UDI-DI: 00885304000846; Serial Numbers A175230001DS to A232160185DS; Model 1025UK - UDI-DI: 00885304022480; Serial Numbers A179210001US to A232060432US; Model 1025KS - UDI-DI: 00853040224734; Serial Numbers A176060001KS to A232220085KS; Model 1025KS-AR - UDI-DI: 00853040224734; Serial Numbers A216240003KS to A229210010KR
DeVilbiss Healthcare LLC is recalling DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025 due to The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
Recommended Action
Per FDA guidance
An URGENT NOTICE MEDICAL DEVICE CORRECTION notification dated 3/9/23 was sent to customers. Actions to be Taken by Our Customers Please immediately click on the hyperlinked Verification Code at the top of this Notice to go to our dedicated instruction manual update website, www.recallrtr.com/1025series (or access the website manually), and follow the simple process set up to: Download electronic copies, or order hard copies, of the updated instruction manual. Download a spreadsheet containing the serial numbers of all affected units sold to your company. Replace the instruction manual for any units in your possession, and distribute the updated instruction manual to your customers, and Submit an Acknowledgement Form confirming the number of instruction manuals you replaced and distributed to customers to replace. Should you need further assistance, we have also set up a dedicated call center, which can be reached at 1 (833) 820-0836, from 8:00 am to 7:00 pm EST Monday through Friday.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026