PlainRecordsFDA · Medical device recall
Omnipod 5 Pods… and 2 more products
- 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…
- Status
- 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.
- Enforcement report date
- July 8, 2026
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Insulet Corporation
- 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.
- Distribution pattern
- 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.
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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.”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)., FDA enforcement report, 2026-07-08. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Alternate Controller Enabled Insulin Infusion Pump
3 products in this recall
Omnipod 5 Pods…
- 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).
- Quantity
- 4,936,056 units
- Codes and lots
- 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.
- Recall started
- May 20, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Alternate Controller Enabled Insulin Infusion Pump
- Root cause (FDA)
- Process design
- What the company told customers
- 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.
- Recall number
- Z-2603-2026
Omnipod DASH Pod…
- 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).
- Quantity
- 1,790,784 units
- Codes and lots
- 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.
- Recall started
- May 20, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Pump, Infusion, Insulin
- Root cause (FDA)
- Process design
- What the company told customers
- 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.
- Recall number
- Z-2604-2026
Omnipod (Eros) Pod…
- Product
- Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
- Quantity
- 289,046 units
- Codes and lots
- 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.
- Recall started
- May 20, 2026
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Pump, Infusion, Insulin
- Root cause (FDA)
- Process design
- What the company told customers
- 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.
- Recall number
- Z-2605-2026
This recall among the others
- FDA's enforcement report came 49 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
- Insulet: 5 other recalls or notices on this site in the three years before this one (from July 9, 2023).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-2603-2026, Z-2604-2026, Z-2605-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-2603-2026, July 8, 2026. "Omnipod 5 Pods… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-2603-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections