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FDAClass I · Medical device · Recalled July 8, 2026
Omnipod (Eros) Pod recall — Insulet Corporation
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.
Class I: most serious — reasonable probability of serious health consequences or death.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2605-2026
- Brand
- Insulet
- Classification
- Class I
- Units affected
- 289,046 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
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).
Affected products
Companies & origin
- Recalling firm location
- Acton, MA, United States
- Firm address
- 50 & 100 Nagog Park, N/A, 01720-3440
Identifying details (verbatim from the notice)
- Product codes / lots
- 1. Model/REF Number: POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). Pack UDI-DI: 20385081120033. Single Pod UDI-DI: 10385081120036. Lot Numbers: L72514. 2. Model/REF Number: ZXR425 (10-Pack), ZXR420 (Single Pod). Pack UDI-DI: N/A. Single Pod UDI-DI: N/A. Lot Numbers: L72516, L72521. 3. Model/REF Number: ZXP425 (10 Pack), ZXP420 (Single Pod). Pack UDI-DI: 20385081120033. Single Pod UDI-DI: 10385081120036. Lot Numbers: L72515, L72509, L72513, L72511, L72510, L71480, L72514.
- Distribution
- 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.
- Firm notified the public via
- Press Release
- FDA event ID
- 99034
- Recall initiated
- May 20, 2026
- FDA classified
- June 30, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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