The Recall Desk
SevereFDA (Devices)·Z-2605-2026·Announced 2026-07-08

Omnipod Eros Pod Insulin Delivery Failure Risk

Insulet Corporation is recalling Omnipod (Eros) Pod units due to external soft cannula damage during manufacturing that can cause insulin leakage instead of delivery to the user. High blood glucose levels and serious complications including diabetic ketoacidosis (DKA) or death may result from under-delivery of insulin.

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 is an FDA Class I medical device recall. Although no illnesses or deaths are reported in the source text, the potential for serious harm including diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, and death—as explicitly stated in the source—combined with the FDA Class I designation meets the criteria for Severe (score 4).

Plain-English summary

Insulet Corporation is recalling 289,046 units of Omnipod (Eros) Pod across multiple model and reference numbers (POD-ZXP425, POD-ZXP420, ZXR425, ZXR420, ZXP425, and ZXP420) due to external soft cannula damage that occurred during manufacturing.

The defect allows insulin to leak around the Pod instead of being delivered to the user. This can occur during both basal and bolus delivery. The primary failure mode is pump under-delivery due to insulin loss through an external leak. If insulin is not delivered properly, users may experience high blood glucose levels.

In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. The recalled pods have been distributed worldwide, including the US and countries including Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Liechtenstein, Netherlands, Norway, Saudi Arabia, Sweden, and Turkey.

Users of affected Omnipod (Eros) Pod units should contact Insulet Corporation immediately for instructions on replacement or discontinuation of use.

The recalled product

Product
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
Manufacturer
Insulet Corporation
Category
Medical Device — Insulin Delivery System
Hazard
  • insulin-under-delivery
  • equipment-failure

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 (8)

  • 1. Model/REF Number: POD-ZXP425 (10 Pack)
  • L72521. 3. Model/REF Number: ZXP425 (10 Pack)
  • L72509
  • L72513
  • L72511
  • L72510
  • L71480
  • L72514.

Distribution

Distributed nationwide across the United States.

Related recalls

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