Insulet Corporation recalls Omnipod DASH Pod. Includes the below

Recalling company

Insulet Corporation

Product

Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod).

Reason

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.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

May 20, 2026

Reported

Jul 8, 2026

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.

Status

Ongoing

Quantity

1,790,784 units

Lot / codes

1. Model/REF Number: POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000051. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11052421, PD1U11012421, PD1U11022421, PD1U02152521, PD1U02192521, PD1U04242522, PD1U10282522, PD1U10292521, PD1U10302521, PD1U10312521, PD1U11032521, PD1U11042521, PD1U01082621. 2. Model/REF Number: POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000020. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11192421, PD1U09102421, PD1U09092421, PD1U09062421, PD1U10242421, PD1U10252421, PD1U10282421, PD1U10292421, PD1U10312421, PD1U11042421. 3. Model/REF Number: BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000020. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11152421, PD1U11182421, PD1U11202421, PD1U09042421, PD1U11132421, PD1U11122421, PD1U11142421, PD1U11152411, PD1U11162421, PD1U04292521, PD1U09032421, PD1U11112421, PD1U04262521. 4. Model/REF Number: BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod). Pack UDI-DI: 20385082000112. Single Pod UDI-DI: 10385082000115. Lot Numbers: PD1U03042521, PD1U09052421, PD1U11072421, PD1U11082421, PD1U03062521, PD1U03032521, PD1U03072521, PD1U02282525, PD1U02282526, PD1U04252521, PD1U11062521, PD1U11072521, PD1U11102521, PD1U11112511, PD1U11112522, PD1U11122521.

Company location

Acton, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2604-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2604-2026 in the FDA Enforcement Report. Also see FDA recall press releases.