DeVilbiss Healthcare LLC: Medical Device Recall in 2023 - (Recall #: Z-1558-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 9, 2023

Date Posted: May 10, 2023

Recall Number: Z-1558-2023

Event ID: 91804

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.

Status: Ongoing

Product Quantity: 143,397 units

Code Information:

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

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated