Insulet Recalls Omnipod 5 Insulin Pods Over Defect That Can Cut Off Insulin — 18 Hospitalizations Already Reported

If You Use the Omnipod 5, Stop and Check Your Pod Lot Number Right Now

For people with diabetes who depend on an insulin pump every hour of every day, a device failure is not an inconvenience — it is a medical emergency. That is exactly the situation Insulet Corporation created when it issued an urgent recall for certain lots of its Omnipod 5 Automated Insulin Delivery pods in March 2026.

Insulet identified a manufacturing issue with certain Omnipod 5 lots through its ongoing product monitoring. Certain pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the pod rather than infuse into the body as intended.

When the pod fails to deliver insulin properly, users may experience high blood glucose levels due to under-delivery. In severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA). Insulet received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. The company reports no deaths related to the issue.

This recall applies only to specific lot numbers distributed in the United States. Not every Omnipod 5 pod is affected — but if yours is, you need to act today. The information below tells you exactly how to check and what to do.

The Key Facts at a Glance

Detail	Information
Company	Insulet Corporation
Device	Omnipod 5 Automated Insulin Delivery System Pods
Unique Device Identifier	10385083000527
Type of Action	Voluntary Medical Device Correction (Recall)
Recall Announced	March 12, 2026
FDA Announcement	March 13, 2026
Hazard	Internal tubing tear → insulin leaks inside pod → under-delivery → high blood sugar → risk of DKA
Reported Serious Injuries	18 (including hospitalizations and DKA)
Deaths Reported	None
Geographic Scope	United States only
Who Is NOT Affected	All other Omnipod 5 pods and all other Omnipod products remain safe to use
Remedy	Free replacement pods
Check Your Lot Number	omnipod.com/check-pods
Insulet Product Support	1-800-641-2049 (24/7)
Live Chat	omnipod.com/current-podders
Official FDA Page	FDA Recall Announcement

What Is Wrong With These Pods — And Why It Is Dangerous

The Omnipod 5 is a small, tubeless, wearable insulin pump that sticks to your skin and delivers insulin automatically for up to 72 hours at a time. It works together with a continuous glucose monitor (CGM) to adjust insulin dosing without injections or fingersticks. For many people with Type 1 or Type 2 diabetes who require insulin, it is not just a convenience — it is how they stay alive.

Because the Omnipod 5 system is designed to deliver insulin continuously, patients may depend on the device to prevent precisely the type of complication that occurs when insulin delivery stops. When the system fails due to a manufacturing defect, the risk of serious harm increases significantly.

Here is what happened with the affected pods:

Devices from specific lots may have a small tear in the internal tubing, which can cause insulin to leak inside the pod instead of being delivered into the body. The patient receives less insulin than programmed — and may have no idea it is happening.

Even short interruptions in insulin delivery can cause blood glucose levels to rise rapidly, particularly for individuals with insulin-dependent diabetes. If not detected in time, this can lead to serious complications, including diabetic ketoacidosis, hospitalization, or other life-threatening events.

The situation is made worse by one specific warning Insulet issued: the risk of under-delivery increases if you use more than one affected pod in a row. There may be multiple pods from impacted lots within the same box. That means simply grabbing a new pod from the same box to replace a failed one could continue the problem.

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What Symptoms Should Alarm You

If you have been using an Omnipod 5 pod from an affected lot and notice any of the following, seek medical attention immediately. Do not wait. These are warning signs of rising blood sugar or diabetic ketoacidosis (DKA):

• Nausea or vomiting
• Abdominal pain
• Extreme thirst or frequent urination
• Confusion or difficulty thinking clearly
• Fatigue or weakness
• A fruity or sweet odor on your breath (a classic DKA warning sign)
• Blood sugar readings that are higher than expected despite your pod showing normal operation

DKA is a life-threatening emergency. If you experience a combination of these symptoms, go to an emergency room. Do not try to manage it at home.

Will the Pod’s Alarm Always Warn You?

Not reliably. If there is a fluid leak inside the pod, you may receive a hazard alarm to notify you to remove your pod. However, Insulet explicitly warns that patients should NOT rely solely on this alarm to detect the problem. The alarm will not activate in every case, which is exactly why checking your lot number is so important — even if your pod appears to be working normally.

How the Problem Was Found — and How Long It Took

Insulet identified the manufacturing issue with certain Omnipod 5 lots through its ongoing product monitoring. Following its investigation, Insulet implemented updates to its manufacturing processes and quality controls, aimed at strengthening detection and prevention to further support the integrity of its products.

The pods involved in this correction represent approximately 1.5% of annual Omnipod 5 pod production globally. That may sound like a small number, but given how many people depend on this device every single day, 1.5% represents a meaningful patient population — and 18 serious adverse events associated with high blood glucose levels, including hospitalization and DKA, have already been reported.

Panasonic Automotive Systems is the supplier of the rearview camera assemblies — (Note: the Omnipod pods’ supplier for the internal tubing component was not publicly named by Insulet in official announcements.)

Insulet expects to incur up to $40 million in costs in 2026 associated with the recall.

Exactly What To Do Right Now

Do not wait for a letter or a phone call. If you use Omnipod 5 pods, follow these steps today.

Step 1 — Check every pod box and tray you currently have.

The lot number can be located on the pod tray lid, the flat side of the pod itself, and on the 5-pack pod box. Every pod in the same box will share the same lot number.

Step 2 — Go to omnipod.com/check-pods.

Customers can visit omnipod.com/check-pods to check lot numbers and request replacement pods at no cost. The lot number lookup on this page will tell you definitively whether your pods are included in the recall.

Step 3 — If your pods are affected, stop using them immediately.

Do not use pods from affected lots. Discontinue use of any impacted pods immediately. If you do not have enough pods due to this issue, talk to your health care provider about other methods of insulin delivery while waiting for pods to be replaced.

Step 4 — Do NOT replace a failed pod with another pod from the same box.

Do not attempt to use another pod from the same box, as multiple defective units may be in a single package. Always confirm the new pod comes from an unaffected lot before applying it.

Step 5 — Contact Insulet for free replacement pods.

Contact Insulet to request replacement pods and return unused pods from affected lots by utilizing the live agent chat at omnipod.com/current-podders, or by calling Insulet Product Support at 1-800-641-2049, available 24/7.

Step 6 — Contact your healthcare provider.

Tell your doctor or endocrinologist what happened, especially if you experienced unexplained high blood sugar readings recently. If you have already been hospitalized or treated for DKA, your medical records from that event are important — keep copies.

Step 7 — Report any adverse reactions to the FDA.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch, or by calling 1-800-FDA-0178.

Who Regulates This Recall and What the FDA Is Doing

This recall is regulated by the U.S. Food and Drug Administration (FDA), which oversees medical devices. The FDA is aware that Insulet issued a letter to affected customers recommending certain Omnipod 5 pods be removed from where they are used or sold. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

The official FDA page for this recall — which includes Insulet’s full announcement as a public service — is available at the FDA’s recalls and safety alerts database. The recall reference is REF: 9056196-03/12/2026-001-C.

The Omnipod 5 Automated Insulin Delivery System, cleared by the FDA for treating patients with both Type 1 and Type 2 diabetes, includes a pod and CGM sensor that are in constant communication, built to provide automated insulin delivery for up to three days without requiring daily injections.

This recall does not affect CGM systems that pair with Omnipod 5. This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.

Legal Investigations Are Underway — You May Have a Claim

No class action lawsuit had been formally filed and certified as of the date of publication, but multiple product liability law firms across the United States have launched active investigations and are already accepting individual cases on behalf of patients harmed by the recalled pods.

Omnipod 5 lawsuits allege that internal tubing damage with certain Omnipod 5 insulin pods may cause the device to fail to deliver insulin properly, resulting in serious diabetic emergencies.

Product liability lawsuits are being investigated over design defects with the insulin pump pods. Omnipod 5 insulin pump lawsuits involve allegations that Insulet Corporation sold a defective device and failed to adequately warn patients about risks linked to diabetic ketoacidosis, hyperosmolar hyperglycemic state, coma and death.

Attorneys investigating these claims are also evaluating whether Insulet failed to provide adequate warnings about the risk of insulin leakage or acted too slowly after receiving reports of serious injuries, including diabetic ketoacidosis, hyperosmolar hyperglycemic state, coma and death.

If you were hospitalized or treated for DKA after using a recalled Omnipod 5 pod, you may have grounds to pursue a product liability lawsuit seeking compensation for medical bills, lost income, and pain and suffering. These cases are typically handled on a contingency basis, meaning you pay no attorney fees unless compensation is recovered.

This situation is part of a broader pattern of legal scrutiny over diabetes device manufacturers. The Dexcom G7 lawsuit and FDA recall — which alleged defective glucose monitors and dangerous alert failures — shows how courts and regulators have treated similar failures in the diabetes technology space. The legal standards around manufacturer accountability for life-sustaining medical devices are well established. To understand how product liability cases against manufacturers are structured more broadly, the Toyota airbag class action settlement — a $78.5 million resolution — is one of the clearer examples of how defect cases reach resolution even without initial class certification.

Your Questions Answered

How do I know if my specific pods are part of this recall?

Check your pod lot number on the pod tray lid, the flat side of the pod itself, or on the side of the 5-pack pod box. Then go to omnipod.com/check-pods and enter that lot number. The page will confirm whether your pods are affected and allow you to request free replacements.

My pod seems to be working fine. Do I still need to check?

Yes. The defect does not always trigger a visible alarm or obvious symptom. Because the Omnipod 5 system is designed to deliver insulin automatically over up to 72 hours, users may not immediately recognize that dosing has been disrupted. Your pod can appear to be functioning while silently under-delivering insulin.

I already used pods from a box — and now I’m seeing it might be recalled. What should I do?

Check your blood sugar carefully, watch for DKA symptoms (nausea, vomiting, abdominal pain, extreme thirst, confusion, fruity breath), and contact your healthcare provider. If you have had unexplained high blood sugar readings recently, tell your doctor and mention the recalled pods. If symptoms are severe, go to an emergency room immediately.

Does this affect my CGM or the Omnipod app?

No. This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings. The CGM, the app, and all other Omnipod products are unaffected.

Does this affect users outside the United States?

No, this issue is limited to Omnipod 5 pods distributed in the United States only.

Will Insulet send me replacement pods, and how long will it take?

Insulet does not anticipate an interruption to customer shipments or the ability to start new customers on Omnipod 5. Contact Insulet at 1-800-641-2049 (24/7) or through the live chat at omnipod.com/current-podders to arrange your free replacement.

What if I don’t have enough pods while I wait for replacements?

If you do not have enough pods due to this issue, talk to your health care provider about other methods of insulin delivery while waiting for pods to be replaced. Do not skip insulin doses — contact your doctor right away to discuss alternatives.

I was hospitalized after using an Omnipod 5. Can I sue?

If your pods came from an affected lot and you were hospitalized for DKA, severe hyperglycemia, or a related complication, you may have a product liability claim against Insulet. Most attorneys handling these cases work on contingency — no upfront cost to you. Consult a product liability attorney as soon as possible, since statutes of limitations on medical device claims vary by state and begin running from the date of injury.

Where is the official FDA information for this recall?

The FDA’s official recall announcement is available at fda.gov/safety/recalls-market-withdrawals-safety-alerts. You can also report adverse events to FDA MedWatch at 1-800-332-1088 or fda.gov/medwatch.

Last Updated: April 6, 2026. This article is for informational purposes only and does not constitute medical or legal advice. If you are experiencing a medical emergency, call 911 or go to your nearest emergency room immediately. Always follow official guidance from Insulet, the FDA, and your healthcare provider. Consult a licensed attorney in your state if you believe you have a legal claim related to this recall.