- Recalling firm
- Insulet Corporation
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 289,046 units
- Distribution pattern
- 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 location
- Acton, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Press Release
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2605-2026
- Recall initiated
- May 20, 2026
- FDA classification date
- June 30, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99034
- Last updated on HTM Vibe
- July 23, 2026