Somerset, PA, United States
DeVilbiss Healthcare LLC recalls
3 recalls recorded since 2018, most recently on 9 March 2023. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 March 2023
- 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.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1558-2023
- DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Ongoing Class II Medical devices
- Recall started
- 18 November 2022
- Reason
- 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 (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
- Distribution
- US Nationwide. Foreign distribution pending.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0724-2023
- DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Ongoing Class II Medical devices
- Recall started
- 19 September 2022
- Reason
- An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
- Distribution
- US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0229-2023
- 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.