DeVilbiss Healthcare LLC 2022-11-23 Health serious FDA
Health · FDA · Recall #FDA-Z-0229-2023
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of… Recall
Issued November 23, 2022 · DeVilbiss Healthcare LLC
In November 2022, DeVilbiss Healthcare LLC recalled the 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
What you should do
- 1 Stop using 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact DeVilbiss Healthcare LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- DeVilbiss Healthcare LLC
- Category
- Health
- Recall date
- November 23, 2022
- Units affected
- Not reported
- Sold at
- US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
- Recall number
- FDA-Z-0229-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- DeVilbiss Healthcare LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.