On May 20, 2026, Insulet started a recall of certain Omnipod 5, Omnipod DASH and Omnipod (Eros) Pods, according to the FDA's recall database.[4] The problem is a small tear in the cannula, the soft tube that carries insulin into the body, just above the skin. Insulin can leak out there instead of being delivered.[1] Insulet sent affected customers a letter on May 26.[1] The FDA issued an Early Alert on June 4 and classified the recall as Class I, its most serious type, on July 2, 2026.[1]
What went wrong
The FDA said some Pods from specific lots may have the tear between the Pod and the point where the cannula enters the body. That can lead to under-delivery of insulin.[1] Users may notice wetness on the skin or the Pod adhesive, or smell insulin. Not always, though: the FDA said the leak can be hard to detect and can go unnoticed.[1]
Here's what surprised us: the leak may not set off any alarm. On Omnipod 5 in Automated Mode, it could trigger an Automated Delivery Restriction alert. The FDA said it can also happen with no alert at all, and told users not to rely only on Pod alerts.[1] In the most severe cases, prolonged high blood glucose can lead to diabetic ketoacidosis (DKA), which the FDA called potentially life-threatening.[1] The FDA noted that the issue does not affect CGM systems or CGM readings.[1]
As of May 20, Insulet had reported 24 serious injuries and no deaths linked to the problem.[1]
What the recall covers
The FDA database lists three recall numbers under one event: Z-2603-2026 for Omnipod 5 Pods, Z-2604-2026 for Omnipod DASH Pods and Z-2605-2026 for Omnipod (Eros) Pods.[3] The records give quantities of 4,936,056 Omnipod 5 units, 1,790,784 Omnipod DASH units and 289,046 Omnipod (Eros) units. Distribution covered the whole United States and 20 other countries.[3] FDA records describe the cause as cannula damage during manufacturing and list the root cause as "process design."[3] The FDA posted the records on June 30, 2026.[4]
This is a separate recall from the one Insulet started in March 2026, which involved a tear in the internal tubing of certain Omnipod 5 Pods.[5]
How to check your lot number
The FDA said to look for the lot number on the Pod tray lid, the Pod box or the Pod itself. Every Pod in a single box comes from the same lot, so if the box's lot is affected, none of its Pods should be used.[1]
Compare your number with the "Full List of Affected Product" that the FDA links from its recall notice.[1] The spreadsheet has a "US Pods" tab and a separate tab for Pods sold outside the US. The US tab lists 138 Omnipod 5 lots, 23 Omnipod DASH lots and one Omnipod (Eros) lot, each with its model and UDI numbers.[2] Insulet also published instructions and pictures to help find the lot number.[1]
What this means for you
The FDA and Insulet said not to use Pods from the affected lots. Anyone wearing an affected Pod should change it right away to resume insulin delivery and confirm that the new Pod is not from an affected lot.[1] Insulet's customer email explains how to report an affected Pod and request a replacement, and users will get a return kit for unused affected Pods.[1] Insulet's Product Support line is 1-800-641-2049, open 24/7, and its page for current users is omnipod.com/current-podders.[1]
If you are running short of Pods, or have questions about insulin delivery or glucose monitoring, talk to your care team or pharmacist.
References
- U.S. Food and Drug Administration. Insulin Pump Recall: Insulet Removes Omnipod PodsSource
- U.S. Food and Drug Administration. Full List of Affected Product: Insulet Omnipod PodsSource
- U.S. Food and Drug Administration. openFDA device recall records for recall event 99034 (Z-2603-2026, Z-2604-2026, Z-2605-2026)Source
- U.S. Food and Drug Administration. Class 1 Device Recall Omnipod 5 Pods (Z-2603-2026)Source
- U.S. Food and Drug Administration. Insulin Pump Recall: Insulet Removes Certain Omnipod 5 PodsSource