FDA Class I Recall Update for Omnipod Pods: What to Do Now

ByBrian “Weence” Bateman

The FDA updated its safety communication on July 2, 2026, confirming a Class I recall for certain Insulet Omnipod pods. If you use Omnipod, check the pod lot, stop using pods from affected lots, change your pod immediately if yours may be affected, monitor glucose closely, and follow your ketone plan—especially if high blood sugar doesn’t improve.

The FDA has issued a Class I recall update for certain Insulet Omnipod pods—the most serious type of recall. A Class I recall means the FDA believes the product could cause serious harm or death if it’s used. The FDA previously issued an Early Alert on June 4, 2026 and then updated the public communication on July 2, 2026 to confirm the Class I classification.

What to know right away: If your Omnipod pods are from an affected lot, the FDA recommends you stop using those pods. If you’re currently using a pod from an affected lot, you should change your pod immediately to resume insulin delivery.

What the FDA says is happening

Insulet identified that some pods from specific lots may have a small tear in the tubing (cannula) just above the skin—between the pod and the point where the cannula enters the body. If this occurs, insulin may leak outside the pod instead of being delivered into the body, which can lead to insulin under-delivery.

  • If you use an affected pod, blood glucose may rise and may not respond as expected to insulin delivery.
  • In severe cases, prolonged high blood glucose can lead to diabetic ketoacidosis (DKA), which is a medical emergency.
  • The FDA states this issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.
  • As of May 20, 2026, Insulet reported 24 serious injuries and no deaths associated with this issue.

The FDA also warns the problem may be difficult to detect. Some people may notice wetness on the skin or pod adhesive or detect an insulin smell, but in some cases it may go unnoticed. The FDA specifically cautions you not to rely only on pod alerts to decide whether insulin delivery is working.

Who needs to check

The FDA’s update applies to these Omnipod systems:

  • Omnipod 5 Automated Insulin Delivery System
  • Omnipod DASH Insulin Management System
  • Omnipod Insulin Management System (Omnipod Eros)

How to check whether your pods are affected

The FDA says to check the lot number on the pod tray lid, pod box, or the pod itself, then compare it to the affected-lot information on the FDA page.

FDA also notes that all pods within a single box will be from a single lot. If that lot is affected, do not use any of the pods in that box.

What to do right now (if you’re currently using a pod)

Follow the FDA “What to Do” steps:

  1. Do not use pods from affected lots. Check the lot number first.
  2. If you’re currently using a pod from an affected lot: immediately change your pod to resume insulin delivery. When you change, confirm the new pod is not from an affected lot.
  3. If your pod supply is depleted: talk to your healthcare provider about other methods of insulin delivery while replacements are provided.
  4. Request your replacement through Insulet’s process. The FDA says affected users should follow Insulet’s customer instructions (including steps to acknowledge the pod is impacted) and request a replacement.
  5. Call Insulet Product Support if you have questions or quality concerns. The FDA lists a 24/7 product support phone line.
  6. Always check the expiration date before using a pod (expired pods may not work as intended).

Why glucose monitoring matters (even if you don’t see big alerts)

If insulin delivery is under-delivering, glucose can stay high until the insulin delivery problem is corrected. Pod systems can also sometimes miss issues—so the FDA emphasizes not relying only on device alerts.

To put that into context, an open-access clinical trial analysis of insulin pump infusion set failures (not Omnipod pods) found that, when prolonged hyperglycemia occurred and sets were removed, the mean duration of continuous time >250 mg/dL before removal was about 5.1 hours (±3.7). That supports the practical idea behind the FDA guidance: if glucose is unexpectedly high, treat it seriously and follow your clinician’s monitoring plan while you troubleshoot.

Have a backup insulin plan

MedlinePlus advises that people using insulin pumps should plan for what to do if the pump malfunctions. It specifically notes that your healthcare provider should prescribe extra insulin in a vial and syringe form in case manual injections are needed.

CDC’s emergency guidance for people using insulin also emphasizes that, in emergencies when your usual insulin delivery method isn’t available, you may need to switch insulin methods and should monitor blood sugar closely and seek medical attention as soon as possible.

Reasonable next step for families/caregivers: contact your diabetes care team and ask them to confirm how you should monitor glucose and check ketones during this recall/troubleshooting period.

When to get urgent or emergency care

If you’re dealing with possible under-delivery of insulin, watch for ketones and signs of DKA risk.

The American Diabetes Association advises calling your doctor if ketones are elevated and going to the ER or calling 911 right away if you have severe symptoms (such as vomiting, trouble drinking, confusion, or heavy breathing) or if ketones stay high or get worse or you can’t reach your doctor.

Reporting problems to the FDA (MedWatch)

The FDA says consumers and health care professionals may report adverse reactions or quality problems experienced with these devices to MedWatch (the FDA Safety Information and Adverse Event Reporting program).

If you suspect an affected pod contributed to insulin under-delivery, consider reporting details that help identify the device and describe what happened (for example, the pod system type and relevant lot information, timing of symptoms, and what your glucose/ketone readings showed).

Bottom line

  • Check your pod lot for the affected lots listed by the FDA.
  • Do not use pods from affected lots.
  • If you’re currently using an affected pod, change your pod immediately to resume insulin delivery and confirm the replacement lot is not affected.
  • Monitor glucose closely and follow your clinician’s plan for ketones and when to escalate to urgent care.

Sources

Editorial note: Weence articles are researched from cited public-health, medical, regulatory, journal, and reputable news sources and may be drafted with AI assistance. They are checked for source support, clarity, and safety guardrails before publication.

This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.

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Brian “Weence” Bateman is a health and medical writer who covers public health updates, healthcare policy, and medical developments affecting communities across the United States. He works closely with dentists and healthcare providers and focuses on making complex medical information clear, accurate, and useful for everyday readers.