Insulet Corporation 2022-11-23 Health critical FDA
Health · FDA · Recall #FDA-Z-0154-2023
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final… Recall
Issued November 23, 2022 · Insulet Corporation
In November 2022, Insulet Corporation recalled the 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.
What you should do
- 1 Stop using 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Insulet Corporation 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
- Insulet Corporation
- Category
- Health
- Recall date
- November 23, 2022
- Units affected
- Not reported
- Sold at
- Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
- Recall number
- FDA-Z-0154-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Insulet Corporation has 3 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.