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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 8, 2026

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 (...

Full official product description

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). | 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). | 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).

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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).; 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).; plus 1 additional official variants listed below.

Identifiers to compare

  • UDI 20385083000579
  • UDI 10385083000527
  • UDI 20385083000425
  • UDI 10385083000411
  • UDI 2038508300043
  • UDI 20385083000548
  • UDI 20385083000135
  • UDI 10385083000114
  • UDI 20385082000051
  • UDI 10385082000023
  • UDI 20385082000020
  • UDI 20385082000112
  • UDI 10385082000115
  • UDI 20385081120033
  • UDI 10385081120036
  • Lot Numbers
  • Lot PH1U01102521
  • Lot PH1U12102421
  • Lot PH1U12172421
  • Lot PH1U11212421
  • Lot PH1U11252421
  • Lot PH1U11222421
  • Lot PH1U12092421
  • Lot PH1U0
  • Lot PH1U02202521
  • Lot PH1U04222521
  • Lot PH1U04232511
  • Lot PH1U04232521
  • Lot PH1U11142521
  • Lot PH1U12042521
  • Lot PH1U12052521
  • Lot PH1U04212521
  • Lot PH1U12192411
  • Lot PH1U12202421
  • Lot PH1U12192421
  • Lot PH1U10212421
  • Lot PH1U10232421
  • Lot PH1U01242521
  • Lot PH1U03082521
  • Lot PH1U04172521
  • Lot PH1U01272513
  • Lot PD1U11012421
  • Lot PD1U11022421
  • Lot PD1U02152521
  • Lot PD1U02192521
  • Lot PD1U04242522
  • Lot PD1U10282522
  • Lot PD1U10292521
  • Lot PD1U1
  • Lot PD1U09102421
  • Lot PD1U09092421
  • Lot PD1U09062421
  • Lot PD1U10242421
  • Lot PD1U10252421
  • Lot PD1U10282421
  • Lot PD1U10292421
  • Lot PD1U11182421
  • Lot PD1U11202421
  • Lot PD1U09042421
  • Lot PD1U11132421
  • Lot PD1U11122421
  • Lot PD1U11142421
  • Lot PD1U11152411
  • Lot PD1U09052421
  • Lot PD1U11072421
  • Lot PD1U11082421
  • Lot PD1U03062521
  • Lot PD1U03032521
  • Lot PD1U03072521
  • Lot PD1U02282525
  • Lot PD1U0
  • Lot L72521
  • Lot L72509
  • Lot L72513
  • Lot L72511
  • Lot L72510
  • Lot L71480
  • Lot L72514
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
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...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, PH1U01272513.4,936,056 unitsZ-2603-2026
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...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, PD1U11122521.1,790,784 unitsZ-2604-2026
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. ZXP...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, L72514.289,046 unitsZ-2605-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class I

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.