Omnipod DASH Pod Recall Issued by Insulet Corporation
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Insulet Corporation is recalling 1,790,784 Omnipod DASH Pods due to potential insulin leakage from manufacturing damage to the soft cannula.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Insulet Corporation is conducting a voluntary recall of Omnipod DASH Pods after external soft cannula damage during manufacturing was identified. This can cause insulin to leak around the Pod instead of being delivered, resulting in under-delivery regardless of basal or bolus settings.
Which Products Are Affected
The recall covers Omnipod DASH Pod units with the following Model/REF Numbers and lot details:
- POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod); Pack UDI-DI: 20385082000051; Single Pod UDI-DI: 10385082000023; specific lots listed in recall Z-2604-2026.
- POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod); Pack UDI-DI: 20385082000020; Single Pod UDI-DI: 10385082000023; specific lots listed.
- BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod); Pack UDI-DI: 20385082000020; Single Pod UDI-DI: 10385082000023; specific lots listed.
- BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod); Pack UDI-DI: 20385082000112; Single Pod UDI-DI: 10385082000115; specific lots listed. A total of 1,790,784 units are affected. Distribution includes the United States 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 You Should Do
Users should monitor blood glucose levels closely. Contact Insulet Corporation regarding affected units.
Why This Matters
Class I recall due to risk of high blood glucose levels that, in severe cases, may lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or death.
Source
FDA recall number Z-2604-2026; https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,693 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.