FDA Omnipod correction: Replace an affected pod right away

If your current Omnipod pod is on the FDA correction list posted on May 26, 2026, the practical answer is yes: replace it right away. FDA says not to keep using pods from affected lots, and if you are wearing one now, to switch to a replacement pod so insulin delivery can continue.

This does not apply to every Omnipod product. The affected correction covers certain lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System pods, also called Omnipod Eros. The first step is to check the lot number before you use the pod.

What the problem is

FDA and Insulet say some pods from certain lots may have a small tear in the cannula tubing just above the skin. If that happens, insulin can leak outside the body instead of reaching it, which can lead to insulin under-delivery. FDA has also said this issue is being reviewed and may be updated if more information becomes available.

What to do right now

Check the lot number on the pod you are wearing and on any backup boxes you have. If the lot is affected, do not use those pods. If the pod you are wearing now is from an affected lot, FDA says to stop using it and immediately change to a pod from an unaffected lot.

If you do not have enough unaffected pods, contact your diabetes care team promptly about temporary insulin-delivery options. Insulet has said replacement pods are available for affected customers at no cost.

Why this matters

This is not just a device glitch. When insulin is under-delivered, blood sugar can rise quickly. In severe cases, prolonged insulin under-delivery can lead to diabetic ketoacidosis, or DKA, which is a medical emergency. CDC says DKA happens when the body does not have enough insulin, and pump problems or missed insulin can trigger it.

FDA also says you may notice wetness on the skin or adhesive, or smell insulin, but the leak can be hard to detect. A pod alert is not always a reliable warning that everything is working normally.

Signs of possible DKA

Watch for symptoms that can go with dangerous high blood sugar or DKA:

Very strong thirst or urinating much more than usual.
Nausea, vomiting, stomach pain, or feeling very tired.
Fast or deep breathing, dry mouth, or fruity-smelling breath.
Blood sugar that stays high, especially if it remains high after changing the pod, or ketones when you test.

CDC says people with diabetes who are sick, or whose blood sugar is 250 mg/dL or higher, should check for ketones every 4 to 6 hours. High ketones are an early warning sign of DKA.

When to get urgent or emergency care

Get urgent medical help the same day if your glucose stays high after you change the pod, you cannot keep fluids down, or you think you may not be getting enough insulin. Call 911 or go to the emergency room right away if you have trouble breathing, repeated vomiting, confusion, drowsiness, or several signs of DKA at once.

Short safety checklist

Check the lot number on the pod you are wearing and on any backup boxes.
If the current pod is affected, change it immediately to one from an unaffected lot.
Keep backup diabetes supplies nearby, including a way to check glucose and ketones if your care team has advised it.
If you run short on usable pods, contact your diabetes clinician promptly about temporary insulin-delivery options.
Do not rely only on pod alerts if your numbers are rising or you feel unwell.

What is known, and what is still unclear

What is known is straightforward: FDA says certain lots across three Omnipod pod lines should not be used, and an affected pod already in use should be replaced immediately. FDA also said Insulet had reported 24 serious injuries and no deaths as of May 20, 2026.

What is not yet clear is how many people may experience a leak before they notice it. FDA is still reviewing the issue. That is why the safest next step is not to wait for symptoms if your lot is affected: check the number, replace the pod, and contact your care team if you do not have a backup plan.

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.