FDA-Device2026-07-08Class IPROCESSING DEFECT

Insulet Omnipod Eros insulin pump pods recalled for potential under-delivery due to cannula damage

OTHERNationwide distributionMedical devices

What this means

Some Omnipod Eros pods may have damage to the soft cannula (the tiny tube that delivers insulin) caused during manufacturing. This damage can cause insulin to leak outside the pod instead of being delivered into your body. If insulin isn't delivered properly, blood glucose levels can rise to dangerous levels.

  • Check your pod lot number against the recalled lots listed in the FDA notice
  • Contact Insulet immediately if you have an affected pod
  • Do not use a recalled pod; use a backup insulin delivery method
  • Monitor your blood glucose levels closely and watch for signs of high blood sugar (thirst, fatigue, frequent urination)
The agency's original wording
Hazard

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is 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. 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.

Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
289,046 units
Manufactured in
50 & 100 Nagog Park, N/A, Acton, MA, United States
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2605-2026

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