Omnipod 5 Pods, Omnipod DASH Pod, and Omnipod (Eros) Pod
Omnipod insulin pods may leak insulin due to cannula damage, causing under-delivery and high blood glucose.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Insulet Corporation of Acton, Massachusetts announced a voluntary Medical Device Correction for specific lots of Omnipod 5, Omnipod DASH, and Omnipod (Eros) Pods due to external soft cannula damage during manufacturing.
This damage results in insulin leaking around the Pod instead of being delivered to the user, regardless of basal or bolus delivery, with the primary failure mode being pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin.
The correction was announced on May 26, 2026, and the company began the recall on May 20, 2026. Distribution was worldwide, including the US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Netherlands, Norway, Saudi Arabia, Sweden and Turkey.
Summary by Recall Canary from the FDA notice.
What to do
If it matches, or you can't tell:
- Visit Check Pod Lot to confirm whether your Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost.
- If a Pod from an affected lot is currently in use, customers should discontinue use and replace it with a Pod from an unaffected lot.
- Customers in the U.S. who have questions or need assistance may contact Insulet Product Support at 1-800-641-2049 (available 24/7) or use the live agent chat at www.omnipod.com/current-podders.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
Incomplete list: 89 of 213 lot codes shown.
Omnipod (Eros) Pod. Includes
- UDI-DI
- 20385081120033
- 10385081120036
- Lot
- L72514
- L72516
- L72521
- L72515
- L72509
- L72513
- L72511
- L72510
- L71480
Omnipod 5 Pods. Includes
- UDI-DI
- 20385083000579
- 10385083000527
- 20385083000425
- Lot
- PH1U01032521
- PH1U01102521
- PH1U12102421
- PH1U12172421
- PH1U11212421
- PH1U11252421
- PH1U11222421
- PH1U12092421
- PH1U09112421
- PH1U11262421
- PH1U04032521
- PH1U12022421
- PH1U12182421
- PH1U04302524
- PH1U05022521
- PH1U01222521
- PR1U11202533
- PH1U09122421
- PH1U10102421
- PH1U12122421
- PH1U01302522
- PH1U02222521
- PH1U05052521
- PH1U10042421
- PH1U12102412
- PH1U01312521
- PH1U03312521
- PH1U05012521
- PH1U09122422
- PH1U09162421
- PH1U09192421
- PH1U09212421
- PH1U09262411
- PH1U09262421
- PH1U10112422
- PH1U10122421
- PH1U10172421
- PH1U12132422
- PH1U01132521
- PH1U01172521
Omnipod DASH Pod. Includes
- UDI-DI
- 20385082000051
- 10385082000023
- 20385082000020
- 20385082000112
- 10385082000115
- Lot
- PD1U11052421
- PD1U11012421
- PD1U11022421
- PD1U02152521
- PD1U02192521
- PD1U04242522
- PD1U10282522
- PD1U10292521
- PD1U10302521
- PD1U10312521
- PD1U11032521
- PD1U11042521
- PD1U01082621
- PD1U11192421
- PD1U09102421
- PD1U09092421
- PD1U09062421
- PD1U10242421
- PD1U10252421
- PD1U10282421
- PD1U10292421
- PD1U10312421
- PD1U11042421
- PD1U11152421
- PD1U11182421
- PD1U11202421
- PD1U09042421
- PD1U11132421
- PD1U11122421
- PD1U11142421
- PD1U11152411
- PD1U11162421
- PD1U04292521
- PD1U09032421
- PD1U11112421
- PD1U04262521
- PD1U03042521
- PD1U09052421
- PD1U11072421
- PD1U11082421
Details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Netherlands, Norway, Saudi Arabia, Sweden and Turkey.
- Event ID
- 99034
- Recall numbers
- Z-2603-2026 to Z-2605-2026
- Company
- Insulet CorporationActon, Massachusetts
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Press Release
Company began the recall
Announced by the company
Listed on Recall Canary
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Summary updated
