Omnipod FDA alert: What to do if your blood sugar is rising

If you use Omnipod, the key step right now is to check whether any of your Pods are from the lots named in Insulet’s May 26 correction. On June 4, 2026, the FDA posted an Early Alert about the issue and told users not to use Pods from affected lots.

The concern is insulin under-delivery. According to the FDA and Insulet, some Pods from specific lots may have a small tear in the tubing, or cannula, just above the skin. If that happens, insulin can leak outside the body instead of being delivered as intended. Blood sugar can rise, and in severe cases prolonged under-delivery can lead to diabetic ketoacidosis, or DKA.

What the FDA alert says and which Omnipod Pods are involved

The FDA says the affected products include certain lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System Pods, also called Omnipod Eros. The agency also says this June 4 Early Alert is separate from an earlier Omnipod 5 action first communicated on March 12, 2026.

An FDA Early Alert is an early public warning about a potentially high-risk device problem. The agency says it is still reviewing this issue and may update the notice as more information becomes available.

As of May 20, Insulet had reported 24 serious injuries and no deaths associated with this issue, according to the FDA. The public notices describe the action as applying to specific affected lots, not every Omnipod Pod.

How to check whether your Pod may be affected

Look for the lot number on the Pod tray lid, the Pod box, or the Pod itself. The FDA says all Pods in a single box come from one lot, so if that lot appears on the affected list, do not use any of the Pods in that box.

If you are not sure whether your lot is included, compare it with the lot list in Insulet’s correction materials or the FDA notice. If you already received an email or letter from Insulet, use that information first. If you still cannot confirm your lot, contact Insulet product support before using the Pod.

Signs insulin may be leaking or under-delivering

The warning signs may be obvious, but not always. The FDA says people using an affected Pod may notice wetness on the skin, dampness on the Pod adhesive, or the smell of insulin. In other cases, the leak may be hard to detect and can go unnoticed.

You may also notice blood sugar rising higher than expected or not responding the way it usually does after insulin delivery. If you use Omnipod 5 in Automated Mode, the FDA says you might get an Automated Delivery Restriction alert. But the agency also warns that this problem can happen without any alert, so it is important not to rely only on the device alarm if your glucose is climbing.

When rising blood sugar becomes urgent

MedlinePlus says common symptoms of hyperglycemia, or high blood sugar, include feeling thirsty, feeling tired or weak, headaches, peeing often, and blurred vision. Very high blood sugar can progress to DKA, which is a medical emergency.

The American Diabetes Association says DKA symptoms may include nausea and vomiting, abdominal pain, rapid or heavy breathing, confusion or trouble concentrating, extreme fatigue, fruity-smelling breath, thirst or very dry mouth, and blood sugar higher than 200 mg/dL or another level set by your clinician.

If you have very high blood sugar and symptoms like vomiting, trouble breathing, confusion, or belly pain, get medical help right away. MedlinePlus also says that if you have a ketone test and your ketones are moderate or high, or you do not have a ketone test and have these symptoms, you should contact your healthcare provider right away or get emergency medical help.

What to do right now if you use Omnipod

Check the lot number on your current Pod supply.
Do not use Pods from affected lots.
If the Pod you are currently wearing is from an affected lot, follow the FDA and Insulet instructions to change it right away so insulin delivery can resume with a Pod that is not on the affected list.
Watch your glucose closely and do not rely only on Pod alerts if your readings are rising.
If ketone testing is part of your diabetes plan, check ketones when your glucose is very high or you feel unwell.
If this issue leaves you short on Pods, contact your diabetes care team promptly about other insulin-delivery options while you wait for replacements.
Contact Insulet for replacement instructions and support.

Do not wait for a routine appointment if your blood sugar keeps rising, you cannot keep fluids down, you have symptoms of DKA, or you are not sure you are getting insulin.

What is still unknown and why the alert matters

What is known: the FDA says some Pods from specific lots may under-deliver insulin because of a manufacturing problem, and the agency considers it a potentially high-risk issue. What is not yet clear from the public notices is how often the defect occurs within the affected lots or whether additional lots could be added later.

The alert matters because people who use insulin pumps depend on steady insulin delivery throughout the day. If delivery is interrupted, blood sugar can rise quickly. The FDA also notes that this issue does not affect continuous glucose monitor systems or CGM readings themselves.

If you use Omnipod for yourself, a child, an older adult, or another family member, this is a good time to make sure everyone involved in daily diabetes care knows where to find lot numbers, how to spot a possible leak, and when to call the care team or seek urgent help.

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.