The Omnipod is a tubeless, wearable insulin pump. Each “Pod” is a single-use, disposable unit that adheres directly to the skin, holds a reservoir of rapid-acting insulin, and delivers it through a small cannula inserted automatically on activation. Pods are worn continuously for up to 72 hours, then discarded and replaced. Insulet Corporation has sold three generations of the system: the original Omnipod Eros, the Omnipod DASH, and the current Omnipod 5, which pairs with a continuous glucose monitor and automatically modulates insulin delivery.
The recalls
In 2026, Insulet initiated two separate voluntary Medical Device Corrections after discovering that Pods were leaving its manufacturing line with damaged insulin-delivery tubing. Both actions were ultimately classified by the FDA as Class I recalls, the agency’s most serious designation, reserved for situations where use of the product may cause serious injury or death. In the aggregate, the two actions cover more than 8.2 million Pods.
The danger: diabetic ketoacidosis
When an insulin pump silently fails to deliver insulin, blood sugar can climb into diabetic ketoacidosis (DKA), a life-threatening emergency requiring hospital treatment. The litigation involves users of Omnipod 5, Omnipod DASH, or Omnipod Eros Pods who were diagnosed with DKA requiring an emergency department visit or hospital admission, with events on or after July 1, 2024, the period matching the earliest recalled-lot manufacturing dates. Because affected pods remain in circulation, there is no hard end date on qualifying events. In the most tragic cases, families have lost loved ones with DKA identified as the cause or a contributing cause of death.
What about identifying the lot number?
Lot numbers can often be recovered from a retained box or tray lid, pharmacy or DME records, an Insulet replacement request, or Omnipod Cloud data. Not having the lot number in hand is not a reason to assume you don’t qualify, identifying it is part of what gets worked through during a case review.
Talk to us, at no cost
If you or a loved one was hospitalized with DKA while using an Omnipod, Pisanchyn Law Firm offers a free, confidential case review, and we do not charge a fee unless we win. Call 1-800-444-5309. This page is part of our mass tort litigation practice.
Frequently Asked Questions
Which Omnipod products are involved? Omnipod 5, Omnipod DASH, and Omnipod Eros Pods, with the recalls covering more than 8.2 million Pods with potentially damaged insulin-delivery tubing.
What qualifies as a serious enough event? A diabetic ketoacidosis diagnosis with an emergency department presentation or hospital admission. Self-managed high blood sugar handled at home generally does not qualify.
I don’t have the lot number. Does that disqualify me? No. Lot numbers can frequently be recovered through pharmacy records, replacement requests, packaging, or Omnipod Cloud data.
This page is for general informational purposes and does not constitute legal or medical advice. Reading it does not create an attorney-client relationship.
