FDA Medical Device Recalls (openFDA)
DeVilbiss Healthcare LLC: DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
- Recall number
- Z-1558-2023
- Recalling firm
- DeVilbiss Healthcare LLC
- Product
- DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
- Status
- Open, Classified
- Initiated
- 2023-03-09
- Posted
- 2023-05-04
- Terminated
- not on file
- Reason
- The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
- Root cause
- Labeling design
- Action
- 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.
- Quantity
- 143,397 units
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- 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
- 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