The Recall Desk
SevereFDA (Devices)·Z-2603-2026·Announced 2026-07-08

Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage

Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified FDA Class I, which per the rubric mandates a minimum score of 4. The defect creates a direct risk of serious patient harm through insulin under-delivery, with potential for life-threatening complications including diabetic ketoacidosis and death explicitly cited in the source.

Plain-English summary

Insulet Corporation is recalling Omnipod 5 Pods due to external soft cannula damage that can occur during manufacturing. When the cannula is damaged, insulin may leak around the Pod instead of being delivered to the user. This defect affects both basal and bolus insulin delivery modes.

The primary risk is insulin under-delivery due to external leakage. When insulin is not delivered properly, users may experience high blood glucose levels. In the most severe cases, prolonged and persistent high blood glucose can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or death.

The recall affects multiple models and lot numbers of Omnipod 5 Pods, with worldwide distribution including the US and 19 other countries. Affected users should contact their healthcare provider immediately to discuss the recalled pods and obtain replacement units or alternative diabetes management options.

Users who have used affected pods and experienced unexplained high blood glucose levels should seek medical attention promptly, particularly if they develop symptoms of DKA or HHS such as persistent nausea, vomiting, shortness of breath, or confusion.

The recalled product

Product
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
Manufacturer
Insulet Corporation
Category
Medical Device — Insulin Infusion Pod
Hazard
  • insulin-leakage
  • under-delivery
  • high-blood-glucose
  • ketoacidosis

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • PH1U01102521
  • PH1U12102421
  • PH1U12172421
  • PH1U11212421
  • PH1U11252421
  • PH1U11222421
  • PH1U12092421
  • PH1U09112421
  • PH1U11262421
  • PH1U04032521
  • PH1U12022421
  • PH1U12182421
  • PH1U04302524
  • PH1U05022521
  • PH1U01222521
  • PR1U11202533
  • PH1U09122421
  • PH1U10102421
  • PH1U12122421
  • PH1U01302522

Distribution

Distributed nationwide across the United States.

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