Insulet recalls 49 lots of Omnipod 5 Pods over a tear in the internal tubing

On March 12, 2026, Insulet sent affected customers a letter telling them not to use Omnipod 5 Pods from certain lots.[1] Some of those Pods may have a small tear in the internal tubing, so insulin can leak inside the Pod instead of reaching the body.[1] The FDA later classified the removal as a Class I recall, its most serious type.[1]

What went wrong inside the Pod

The tear is in the part of the soft cannula, the thin tube that carries insulin, that sits hidden inside the Pod.[2] The FDA recall record says the damage happened during manufacturing.[2] The main result is under-delivery of both basal and bolus insulin.[2] In some cases leaked insulin can short the Pod's circuitry, which stops delivery altogether.[2]

Here's what stood out to us: the Pod may give no warning. A leak can set off a hazard alarm, but the FDA said that in some cases there is no alarm or alert and the problem goes unnoticed.[1] Glucose that keeps rising could bring up an Automated Delivery Restriction alert, and the FDA said users should not rely only on alarms.[1] The risk rises if someone uses more than one affected Pod in a row.[1]

Under-delivery can lead to high blood glucose and, in the most severe cases, diabetic ketoacidosis (DKA).[1] As of April 17, 2026, Insulet had reported 29 serious injuries and no deaths linked to the issue.[1] The FDA said the problem does not affect CGM systems or CGM readings.[1]

How the recall changed

The FDA posted an Early Alert on March 18, 2026.[1] On April 10, 2026, Insulet sent an updated letter that expanded the lot list to include expired Pods and said users may not be able to detect the defect.[1] On April 29 the FDA added the expired lots and confirmed the Class I classification.[1] A correction on April 30 fixed the serious-injury count.[1]

The FDA's recall record lists 1,240,115 units from 49 lots, distributed nationwide.[2] Insulet said the issue is limited to lots distributed in the United States, that it has updated its manufacturing processes and quality controls, and that it has enough supply to replace affected Pods.[4]

This is a different recall from the one Insulet started on May 26, 2026, which covered a tear in the cannula just above the skin, outside the Pod.[5]

What this means for you

Insulet and the FDA said not to use Pods from the affected lots. If the Pod you are wearing is from one, they said to change it right away for a Pod from an unaffected lot.[1] Insulet asked users to acknowledge the notice at omnipod.com/check-pods.[1] Replacements and returns go through the Podder Support live chat at omnipod.com/current-podders or Product Support at 1-800-641-2049, open 24/7.[1] Insulet also said not to use expired Pods.[4]

If you are short on Pods or have questions about insulin delivery, talk to your care team or pharmacist.

How to check your lot number

Insulet said the lot number is printed on the Pod tray lid, on the side of the 5-pack box and on the flat side of the Pod, with pictures in Appendix A of its notice.[4] Every Pod in one box comes from the same lot, so if the box's lot is affected, none of those Pods should be used.[4]

Compare your number with the Full List of Affected Product linked from the FDA recall notice.[1] That spreadsheet lists 49 lot numbers, each starting with "PH1U".[3] Insulet's Appendix B lists the lots with their expiration dates.[4] The checker at omnipod.com/check-pods also looks up a lot for you.[1]

We will add a dated update if Insulet or the FDA changes or closes the recall.