Z-1558-2023Class II

DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

Name: Z-1558-2023 DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Creator: DeVilbiss Healthcare LLC
Published: 2023-03-09
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2023-03-09 / Open, Classified / root cause: labeling and UDI

FDA source

DeVilbiss Healthcare LLC began a recall of DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR on 2023-03-09. FDA classified it as Class II and gives the reason as "The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard". 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-1558-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-09
Posted: 2023-05-04
Recalling firm: Sunrise Medical, Inc.
Product: DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Product code: CAW Generator, Oxygen, Portable
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 143,397 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1558-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1558-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-05-04

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)