Omnipod 5 Pods — Class I medical device recall Z-2603-2026

Ongoing recall by Insulet Corporation, reported 2026-07-08, distributed nationwide. External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of be

Recall number	`Z-2603-2026`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Insulet Corporation, Acton, MA, United States
Recall initiated	2026-05-20
Classified	2026-06-30
Reported by FDA	2026-07-08
Distributed	Nationwide (US)
Countries outside the US	AT, AU, BE, CA, CH, DE, DK, FI, FR, GB, GR, IL, IT, KW, NL, NO, SA, SE, TR
Quantity	4,936,056 units
Reason classes	packaging
UPC / GTIN / UDI-DI	`10385083000114`, `10385083000411`, `10385083000527`, `20385083000135`, `20385083000425`, `20385083000548`, `20385083000579`
Lot numbers	`PH1U01022521`, `PH1U01032521`, `PH1U01072521`, `PH1U01092621`, `PH1U01102521`, `PH1U01132521`, `PH1U01172521`, `PH1U01222521`, `PH1U01222522`, `PH1U01232522`, `PH1U01242521`, `PH1U01272513`, `PH1U01302522`, `PH1U01312511`, `PH1U01312521`, `PH1U02032521`, `PH1U02042521`, `PH1U02132511`, `PH1U02202521`, `PH1U02212521`, `PH1U02222521`, `PH1U03082521`, `PH1U03202521`, `PH1U03262521`, `PH1U03282521`, `PH1U03312521`, `PH1U04032521`, `PH1U04042521`, `PH1U04092521`, `PH1U04102521`, `PH1U04112521`, `PH1U04172521`, `PH1U04182521`, `PH1U04212521`, `PH1U04222521`, `PH1U04232511`, `PH1U04232521`, `PH1U04302524`, `PH1U05012521`, `PH1U05022521` and 112 more
Model numbers	`BLE-H1-529`, `OMNI-I1-6220`, `OMNI-I1-6720`, `OMNI-I1-6729`, `POD-OMNI-I1-6220`, `POD-OMNI-I1-6720`

Product

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), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2603-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.