The Recall Desk
CriticalFDA (Devices)·Z-2604-2026·Announced 2026-07-08

Omnipod DASH Pod insulin pump affected by external cannula damage

Insulet Corporation is recalling Omnipod DASH Pods worldwide due to external soft cannula damage during manufacturing that can cause insulin to leak around the pod instead of being delivered. This may lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis or death.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that the defect can lead to death; the FDA's own classification is Class I. Per the rubric, if reported deaths exist anywhere in the source text, the score is 5 regardless of other factors. Additionally, FDA Class I recalls never score below 4.

Plain-English summary

Insulet Corporation is recalling approximately 1.79 million Omnipod DASH Pods distributed worldwide due to a manufacturing defect affecting the external soft cannula. The cannula damage can cause insulin to leak outside the pod rather than being delivered to the user, regardless of whether basal or bolus delivery is active.

When insulin is not delivered properly, users may experience dangerously 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.

Affected model and reference numbers include POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod), POD-BLE-I1-529 (10-Pack), BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod), BLE-C1-529 (10-Pack), and BLE-C1-520 (Single Pod), with specific lot numbers listed in the recall notice. Distribution spans the United States and Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Liechtenstein, Netherlands, Norway, Saudi Arabia, Sweden, and Turkey.

Users should contact Insulet Corporation immediately for instructions on obtaining replacement pods or discontinuing use if affected by this recall.

The recalled product

Product
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single
Manufacturer
Insulet Corporation
Category
Medical Device — Insulin delivery pump
Hazard
  • insulin-under-delivery
  • high-blood-glucose
  • diabetic-ketoacidosis
  • death

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)

  • 1. Model/REF Number: POD-BLE-I1-525 (5-Pack)
  • PD1U11012421
  • PD1U11022421
  • PD1U02152521
  • PD1U02192521
  • PD1U04242522
  • PD1U10282522
  • PD1U10292521
  • PD1U10302521
  • PD1U10312521
  • PD1U11032521
  • PD1U11042521
  • PD1U01082621. 2. Model/REF Number: POD-BLE-I1-529 (10-Pack)
  • PD1U09102421
  • PD1U09092421
  • PD1U09062421
  • PD1U10242421
  • PD1U10252421
  • PD1U10282421
  • PD1U10292421

Distribution

Distributed nationwide across the United States.

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