Class I recallOngoing

Omnipod 5 Automated Insulin Delivery System and Omnipod DASH Insulin Management System recall — FDA event 99034

FDA · FDA event 99034 · Posted Jun 30, 2026

Published Jun 30, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references Omnipod 5 Automated Insulin Delivery System and Omnipod DASH Insulin Management System by Insulet Corporation.

Products affected by FDA event 99034
Model	Description	Lot / serial range	Manufactured	Status
Z-2603-2026	Z-2603-2026	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.	Not provided in the normalized record	Ongoing
Z-2605-2026	Z-2605-2026	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.	Not provided in the normalized record	Ongoing
Z-2604-2026	Z-2604-2026	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.	Not provided in the normalized record	Ongoing

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.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

May 20, 2026
Recall initiated
Date recorded by the FDA.
Jun 30, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99034
Published: Jun 30, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Omnipod 5 Automated Insulin Delivery System and Omnipod DASH Insulin Management System recall — FDA event 99034

FDA · FDA event 99034 · Posted Jun 30, 2026

Published Jun 30, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 99034
Model	Description	Lot / serial range	Manufactured	Status
Z-2603-2026	Z-2603-2026	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.	Not provided in the normalized record	Ongoing
Z-2605-2026	Z-2605-2026	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.	Not provided in the normalized record	Ongoing
Z-2604-2026	Z-2604-2026	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.	Not provided in the normalized record	Ongoing

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.

Units affected

See official FDA record

Omnipod 5 Automated Insulin Delivery System and Omnipod DASH Insulin Management System recall — FDA event 99034

Follow Omnipod 5 Automated Insulin Delivery System and Omnipod DASH Insulin Management System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Omnipod 5 Automated Insulin Delivery System and Omnipod DASH Insulin Management System recall — FDA event 99034

Follow Omnipod 5 Automated Insulin Delivery System and Omnipod DASH Insulin Management System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline