Omnipod 5 Pods Recall Due to Insulin Leak Risk
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Insulet Corporation is recalling 4,936,056 Omnipod 5 Pods worldwide after manufacturing damage caused external insulin leaks.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references United States. 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, devices.
What Happened
Insulet Corporation initiated a voluntary Class I recall of Omnipod 5 Pods due to external soft cannula damage during manufacturing. This defect causes 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 4,936,056 units of Omnipod 5 Pods distributed nationwide in the US and to Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Liechtenstein, Netherlands, Norway, Saudi Arabia, Sweden, and Turkey. Affected models include:
- POD-OMNI-I1-6720 (Pack UDI-DI: 20385083000579; Single: 10385083000527)
- POD-OMNI-I1-6220 (Pack UDI-DI: 20385083000425; Single: 10385083000411)
- OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod)
- OMNI-I1-6220 (Pack UDI-DI: 2038508300043; Single: 10385083000411)
- OMNI-I1-6720 (Pack UDI-DI: 20385083000548; Single: 10385083000527)
- BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod) (Pack UDI-DI: 20385083000135; Single: 10385083000114) Specific lot numbers for each model are listed in FDA recall Z-2603-2026.
What You Should Do
The recall was initiated via press release on May 20, 2026. Consumers should contact Insulet Corporation for return or refund instructions.
Why This Matters
Failure to deliver insulin properly can cause high blood glucose levels, and in severe cases, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or death.
Source
FDA Enforcement Report, recall number Z-2603-2026, event ID 99034. 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 (1,602 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.