Early Alert: Insulin Pump Issue from Insulet

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Insulet has issued a letter to affected customers recommending certain Omnipod 5 Pods be removed from where they are used or sold.

Affected devices:
Device Name: Omnipod 5 Pods
Unique Device Identifier: 10385083000527

Full List of Affected Product [XLSX 17 KB]

What to Do

Do not use affected Pods. If you do not have enough Pods due to this issue, talk to your health care provider about other methods of insulin delivery.

On March 12, Insulet sent all affected customers a letter recommending the following actions:

Check the lot number on the Pod packaging or device to determine if it is from an affected lot.
Do not use pods from affected lots. Discontinue use of any impacted Pods immediately.
If you do not have enough Pods due to this issue, talk with your health care provider to find other methods of insulin delivery while waiting for Pods to be replaced. Always follow your health care provider's guidance on appropriate glucose monitoring.
Always confirm Pod expiration dates prior to use and do not use Pods that are past expiration.
Visit omnipod.com/check-pods to acknowledge receipt and check to see if your lot is affected.
Contact Insulet to request replacement Pods and return unused Pods from affected lots or to receive additional support by:
- Utilizing Insulet’s live agent chat by clicking the Podder Support button in the lower right of this page: https://www.omnipod.com/current-podders
- Calling Insulet’s Product Support phone line at 1-800-641-2049, available 24/7

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Insulet stated that Pods from certain lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the Pod instead of being fully infused in the body as intended. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated.

If there is a fluid leak inside the Pod, the device may trigger a hazard alarm. If a hazard alarm occurs, users should remove their Pod and replace it immediately to restore insulin delivery. The risk of under-delivery increases if a user applies more than one Pod from an affected lot consecutively.

This issue does not affect continuous glucose monitoring systems (CGM) or CGM readings.

As of March 12, Insulet has reported 18 serious injuries and no deaths associated with this issue.

Device Use

Omnipod is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Insulet at 1-800-641-2049 or visit https://www.omnipod.com/current-podders to reach a live chat agent.

Additional FDA Resources

Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S. [03/13/2026]

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.

Urgent Medical Device Correction | Omnipod [03/12/2026]

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.