FDA Identifies Insulet's Omnipod Pod Cannula-Tear Action as Most Serious Recall Type

The US Food and Drug Administration has identified Insulet's action on certain Omnipod insulin Pods as the most serious type of recall, according to the agency's recall notice, which is marked current as of July 2. The FDA said the device "may cause serious injury or death if you continue to use it."

The notice covers Pods from specific lots used with the Omnipod 5 Automated Insulin Delivery System, the Omnipod DASH Insulin Management System and the original Omnipod Insulin Management System, known as Omnipod Eros. FDA describes the action as removing devices from where they are used or sold, and says the affected products and recommendations have not changed. Insulet's own customer notice dated May 26 calls it a voluntary medical device correction and says it is separate from a correction issued on March 12, 2026, that affected certain Omnipod 5 Pods in the US.

The reported issue

According to the FDA notice, Insulet identified that some Pods from specific lots may have a small tear in the tubing, or cannula, just above the skin, between the Pod and the point where the cannula enters the body. If that happens, insulin may leak outside the Pod instead of being fully delivered, potentially leading to under-delivery of insulin.

The notice says users may notice wetness on the skin or Pod adhesive or the smell of insulin, but that the leak may be hard to detect. For Omnipod 5 in Automated Mode, it could trigger an Automated Delivery Restriction alert, but the issue may also occur without any alert. In the most severe cases, prolonged high blood glucose can lead to diabetic ketoacidosis, the FDA said. The agency noted that the issue does not affect continuous glucose monitoring systems or their readings.

"As of May 20, Insulet has reported 24 serious injuries and no deaths associated with this issue," the FDA notice states.

What Insulet told customers

In its May 26 letter, Insulet told customers not to use Pods from the affected lots, to check lot numbers on the Pod tray lid, box or Pod itself, and to change immediately any affected Pod in use. Customers can request replacements and will receive return kits for unused affected Pods, according to the FDA notice.

Insulet said in its notice that it has identified the cause of the manufacturing issue, implemented corrective actions designed to prevent recurrence and strengthened in-process monitoring and quality controls designed to detect cannula tears. "We have sufficient supply available to replace affected Pods and do not anticipate any disruption to product availability," the company said. Pods not included in the affected lots remain safe to use, according to Insulet.