Insulet Corporation: 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-I

Company / brand

Insulet Corporation

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 / 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.

Classification

Class I

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-05-20

Code info

1. Model/REF Number: POD-OMNI-I1-6720. Pack UDI-DI: 20385083000579. Single Pod UDI-DI: 10385083000527. Lot Numbers: PH1U01032521, PH1U01102521, PH1U12102421, PH1U12172421, PH1U11212421, PH1U11252421, PH1U11222421, PH1U12092421, PH1U09112421, PH1U11262421, PH1U04032521, PH1U12022421, PH1U12182421, PH1U04302524, PH1U05022521, PH1U01222521, PR1U11202533, PH1U09122421, PH1U10102421, PH1U12122421, PH1U01302522, PH1U02222521, PH1U05052521, PH1U10042421, PH1U12102412, PH1U01312521, PH1U03312521, PH1U05012521, PH1U09122422, PH1U09162421, PH1U09192421, PH1U09212421, PH1U09262411, PH1U09262421, PH1U10112422, PH1U10122421, PH1U10172421, PH1U12132422, PH1U01132521, PH1U01172521, PH1U02132511, PH1U03202521, PH1U03262521, PH1U04042521, PR1U11192531, PH1U11192511, PR1U01162621, PH1U09172421, PH1U09182421, PH1U09202421, PH1U10142421, PH1U10152421, PH1U10162421, PH1U01232522, PH1U01312511, PH1U02032521, PH1U02042521, PH1U02212521, PH1U03282521, PH1U04092521, PH1U04102521, PH1U04112521, PH1U10172522, PH1U10182521, PH1U10202521, PH1U10212521, PH1U10222521, PH1U10232521, PH1U10242521, PH1U10252521, PH1U11152521, PH1U11172511, PH1U11172521, PH1U11182521, PR1U11182531, PR1U11182541, PR1U11192541, PH1U11192521, PR1U11192532, PR1U11192542, PR1U11202521, PR1U11202532, PR1U11202541, PR1U11202542, PR1U11212521, PR1U11222531, PR1U11222541, PR1U11222521, PR1U11232541, PR1U11242521, PR1U11242531, PR1U11252541, PR1U11252512, PR1U11252521, PR1U11262521, PR1U12012521, PR1U12022521, PR1U12032521, PR1U12102522, PR1U12112521, PR1U12122521, PR1U12132511, PR1U12132521, PR1U12152521, PR1U12162521, PR1U12172521, PR1U01132621, PR1U01152621, PR1U01172621, PR1U01202621, PR1U01212621, PR1U01222621, PR1U01232621, PR1U01272621, PR1U01302641, PR1U01312631, PR1U02022641, PR1U02032631, PR1U02032641, PR1U02042641, PR1U02052631, PR1U02052641, PR1U02062631, PR1U02112641, PR1U02132611, PR1U02132641, PR1U11252531, PR1U11262541, PH1U06282422. 2. Model/REF Number: POD-OMNI-I1-6220. Pack UDI-DI: 20385083000425. Single Pod UDI-DI: 10385083000411. Lot Numbers: PH1U10182422, PH1U02202521, PH1U04222521, PH1U04232511, PH1U04232521, PH1U11142521, PH1U12042521, PH1U12052521, PH1U01092621. 3. Model/REF Number: OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). Pack UDI-DI: N/A. Single Pod UDI-DI: N/A. Lot Numbers: PH1U01222522. 4. Model/REF Number: OMNI-I1-6220. Pack UDI-DI: 2038508300043. Single Pod UDI-DI: 10385083000411. Lot Numbers: PH1U04182521, PH1U04212521, PH1U12192411. 5. Model/REF Number: OMNI-I1-6720. Pack UDI-DI: 20385083000548. Single Pod UDI-DI: 10385083000527. Lot Numbers: PH1U01022521, PH1U12202421, PH1U12192421, PH1U10212421, PH1U10232421. 6. Model/REF Number: BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod). Pack UDI-DI: 20385083000135. Single Pod UDI-DI: 10385083000114. Lot Numbers: PH1U01072521, PH1U01242521, PH1U03082521, PH1U04172521, PH1U01272513.

Product quantity

4,936,056 units

Voluntary mandated

Voluntary: Firm initiated

City

Acton

State

MA

Country

United States

Event id

99034

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