Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack

FDA device recall Z-2603-2026 · posted 2026-06-30 · Open, Classified

Recall details

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.

Action taken

Insulet initially issued a press release on 05/26/2026 along with an "Urgent: Medical Device Correction" on the same day. Consignees were notified of the issue and hazard and instructed to not used Pods from affected lots and to check the lot number on the Pod tray lid, box or Pod itself to determine if affected Pods are on hand. If impacted Pods are on hand, consignees were instructed to discontinue use of any impacted Pod immediately, immediately change the Pod if currently using an affected lot, and acknowledge the email confirming receipt. Confirming receipt of the email is needed even if no affected Pods are on hand. Customers will receive a return kit with clear instructions on how to send back any unused affected Pods.

Root cause

Process design

Status

Open, Classified

Product code

QFG

Quantity affected

4,936,056 units

Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Nethe

Date initiated

2026-05-20

Date posted

2026-06-30

Location

Acton, MA

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