Insulet recalled certain Omnipod® 5 Pod Insulin Pumps after 18 serious injuries occurred when insulin leaked inside the pod instead of being delivered to the patient.
Need a Texas Omnipod 5 Insulin Pump Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were hospitalized, diagnosed with Diabetic Ketoacidosis (DKA), or experienced dangerous blood sugar complications due to a defective Omnipod 5 Pod Insulin Pump, contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit
Insulet Recalls Omnipod 5 Pods for Insulin Leak Risk
In March 2026, Insulet Corporation announced a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods distributed in the United States.
The recall applies to specific lot numbers only; other Omnipod® 5 Pods and all other Omnipod® products were not affected. Insulet is providing replacement Pods at no cost to affected customers.
What is the Problem?
The problem is that the tubing inside the pod can tear or develop leaks, which may result in the device leaking insulin inside the pod rather than delivering insulin to the patient. This may result in under-delivery of insulin to the patient, which may pose life-threatening health risks to patients, including Diabetic Ketoacidosis (DKA).
According to the recall warning posted by the FDA:
“If insulin is not delivered properly, you may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated.”
What is the Omnipod 5 Pod Defect?
The defect involves the internal tubing inside the Omnipod® 5 Pod. This component is responsible for delivering insulin from the Pod’s reservoir into the patient’s body through the cannula. Insulet identified that certain Pods from specific manufacturing lots may have a small tear in this internal tubing.
If the tubing is torn, insulin can leaks inside the Pod rather than being delivered into the patient’s body. The result is under-delivery of insulin. In other words, the patient receives less insulin than they need. They may not be aware of the problem until a dangerous complication occurs, like DKA.
Can I Rely On The Alarm?
Users may receive a hazard alarm on the Omnipod 5 app prompting them to remove the Pod, but Insulet warns that patients should NOT rely solely on this alarm to detect the problem. The danger is compounded when a patient replaces a failed Pod with another Pod from the same box, because multiple Pods within a single package may come from the same affected lot.
How Many People Were Injured?
Insulet confirmed it has received 18 reports of serious adverse events connected to this defect, including:
- High blood glucose levels (hyperglycemia)
- Hospitalization
- Diabetic ketoacidosis (DKA)
No deaths were reported. The affected Pods represent approximately 1.5% of Insulet’s annual global Omnipod® 5 Pod production. Texas has a large population of insulin-dependent diabetes patients, and many Omnipod 5 users across Houston, Dallas, San Antonio, Austin, and throughout rural Texas may have received Pods from affected lots.
Which Omnipod 5 Pods Are Affected?
The correction applies to specific lot numbers of Omnipod® 5 Pods distributed in the United States. To check whether your Pods are from an affected lot:
- Visit omnipod.com/check-pods to look up your Pod lot number
- The lot number is printed on the Pod tray lid, on the flat side of the Pod itself, and on the side of the 5-pack Pod box
- All Pods within the same box share the same lot number — if any Pod in a box is from an affected lot, do not use any Pod from that box
If your Pods are from an affected lot, stop using them immediately and contact Insulet Product Support at 1-800-641-2049 (available 24/7) to request free replacement Pods.
Legal Help for Omnipod 5 Users in Texas
Texans living with Type 1 and Type 2 diabetes rely on insulin pump technology to manage their blood sugar around the clock. These patients rely on devices like the Omnipod 5 Pod to function and stay alive.
The Omnipod® 5 is a wearable insulin pump Pod that attaches to the skin. It is supposed to delivers a continuous, automated supply of insulin. It integrates with continuous glucose monitors (CGMs) and can be controlled by a smartphone app. When it works as designed, it gives patients with diabetes a reliable, hands-free way to manage their insulin levels without injections.
But when it fails, the consequences can rapidly become life-threatening. If insulin leaks inside the Pod instead of entering the patient’s body, the under-delivery of insulin can leads to rising blood glucose levels. If not caught and corrected quickly, this can escalate into Diabetic Ketoacidosis (DKA), a life-threatening condition that requires emergency medical treatment and hospitalization.
Need a Texas Omnipod 5 Insulin Pump Lawyer?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.
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