Stop using nowMedical device recall · FDA · Published October 17, 2022
Insulet Omnipod Dash PDM Insulin Pump Recall: Battery Fire Hazard
Insulet recalls Omnipod Dash PDM insulin delivery systems with battery swelling, leaks, and overheating risks. Owners should stop using affected units immediately to prevent fire hazards.
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.
Take action
Contact the company
📍Recalling firmInsulet Corporation100 Nagog Park · Acton, MA 01720-3440
“Insulet Omnipod Dash PDM Insulin Pump Recall: Battery Fire Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59878-insulet-omnipod-dash-pdm-insulin-pump-recall-battery-fire-hazard. Based on FDA recall #Z-0154-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0154-2023%22&limit=1).
The FDA announced on Oct. 17, 2022, that Insulet Corporation is recalling ASM Omnipod Dash PDM insulin delivery systems due to battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard. The agency classified the recall as Class I.
How to tell if you have it
Brand: Insulet
Product: ASM Omnipod Dash PDM, insulin delivery system
Distribution: US nationwide, Canada, Europe, Australia, and the Middle East
The hazard
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.
Context
GovInfoNow's records show Insulet Corporation has 11 other recalls on record since Dec. 18, 2018. Other recent recalls of similar products include Medtronic MiniMed 780G Insulin Pump Recall (July 13, 2026), Medtronic MiniMed 640G Insulin Pump Recall (July 13, 2026), and Medtronic MiniMed 670G Insulin Pump Recall (July 13, 2026).
How to tell if you have this one
Check for the model numbers PT-000010, PT-000011, or PT-000030 on the device or packaging. The recall covers units sold in Canada and the U.S. with specific serial numbers.
Brand
Insulet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the affected Omnipod Dash PDM insulin delivery system to prevent fire hazards.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0154-2023 (October 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0154-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.