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Omnipod 5 Pods
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MEDICAL DEVICE RECALLCRITICAL

Omnipod 5 Pods

Insulet recalls Omnipod 5 Pods over cannula damage causing insulin leaks and under-delivery, risking DKA.

What to do

Stop using the affected Omnipod 5 Pods immediately. Contact Insulet Corporation for replacement pods and further instructions. Monitor your blood glucose closely and seek medical attention if you experience symptoms of high blood glucose or DKA.

Recalled
Listed
Updated
Recall No.
Z-2603-2026
Agency
FDA
Firm
Insulet Corporation
Recall ID
99034
Status
ONGOING

Why it was recalled

Insulet Corporation is recalling Omnipod 5 Pods due to external soft cannula damage during manufacturing that can cause insulin to leak around the Pod, leading to under-delivery. This may result in high blood glucose levels, and in severe cases, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or death.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
Omnipod 5 Pods. IncludesPH1U01032521, 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 (+112 more, see the official notice)Z-2603-202620385083000579, 10385083000527, 20385083000425
Omnipod DASH Pod. IncludesPD1U11052421, 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 (+12 more, see the official notice)Z-2604-202620385082000051, 10385082000023, 20385082000020, 10385082000023, 20385082000020, 10385082000023, 20385082000112, 10385082000115
Omnipod (Eros) Pod. IncludesL72514, L72516, L72521, L72515, L72509, L72513, L72511, L72510, L71480Z-2605-202620385081120033, 10385081120036, 20385081120033, 10385081120036

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification