Medical device correction: Omnipod 5 (Insulet – March 2026)

The pods are being corrected because some pods may have a small tear in the inner tubing that delivers insulin. This tear could cause insulin to leak inside the pod instead of being fully infused into the body as intended. If insulin is not delivered properly, the person wearing the pod may experience high blood glucose levels. This can lead to a serious medical condition called diabetic ketoacidosis (DKA), which requires immediate medical treatment.

Insulet advises that customers should visit omnipod.com/check-pods to learn if their pods are affected by this correction and request replacement pods at no cost.

If a customer is currently wearing a pod from an affected lot, Insulet advises that they should stop wearing it and replace it with a pod from an unaffected lot.

As of March 12, Insulet had received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. No deaths had been reported. This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.

To learn more about this recall, you can take one or more of the steps below.

• Talk to your doctor or pharmacist.
• Call Insulet Product Support at 1-800-641-2049 (available 24/7). TTY users should call 711.
• Use the live agent chat at omnipod.com/current-podders.
• Visit the FDA website.