DeVilbiss Healthcare recalls
3 official recalls and safety alerts involving DeVilbiss Healthcare since 2022-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with DeVilbiss Healthcare or the relevant agency.
- 2023-05-10
USDeVilbiss Healthcare LLC recalls DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
- 2022-12-28
- US
DeVilbiss Healthcare LLC recalls DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
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…
- 2022-11-23
- US
DeVilbiss Healthcare LLC recalls 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
FDA · DeviceDeVilbiss Healthcare LLCUS Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and…Official notice →