FDA Class I recall: Omnipod (Eros) Pod cannula damage causes insulin to leak and under-deliver (Insulet)
The U.S. FDA classified Insulet's tubeless insulin pump, the Omnipod (Eros) Pod, as a Class I recall, its most serious category, after external soft cannula damage during manufacturing was found to let insulin leak around the Pod instead of reaching the user. The recall covers 289,046 units distributed in the United States and 20 other countries.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmInsulet Corporation
- ReasonExternal 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.
- DistributionWorldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Nethe...
- Recall initiated2026-05-20
Key points
- The FDA classified it Class I, its most serious category (Z-2605-2026, reported July 8, 2026, status ongoing).
- The recall covers 289,046 Omnipod (Eros) Pods, including model/REF numbers POD-ZXP425/420, ZXR425/420 and ZXP425/420.
- The cause is external soft cannula damage during manufacturing, letting insulin leak around the Pod for both basal and bolus delivery.
- FDA records cite high blood glucose and, if prolonged, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or death.
- Distribution spans the United States plus 20 countries including Austria, Canada, Germany, the United Kingdom and Italy.
1How a tubeless insulin pump works
The Omnipod is a tubeless insulin pump worn directly on the body. Insulin is held inside a small unit called a Pod and delivered through a thin, soft tube (a cannula) inserted under the skin, providing both background insulin through the day (basal) and additional doses around meals (bolus).
The cannula is the only path insulin takes into the body, so if it is damaged, insulin leaks out rather than entering the body even while the pump itself operates normally.
2A failure that looks like normal operation
What defines this defect is the pattern FDA records describe: the user may believe the pump is working while insulin is in fact not being delivered. Because the leak occurs the same way for basal and bolus delivery, attempting to correct by increasing the dose is unlikely to help.
The consequence is high blood glucose, and as the outcome of that state persisting, the FDA cites diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), and, in the most severe cases, death. DKA is a serious condition in which a lack of insulin drives the body to break down fat, turning the blood acidic.
3Scale: 289,046 units across 21 countries
The scale is also distinctive. The recall covers 289,046 units, distributed across the United States and in Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, the United Kingdom, Greece, Israel, Italy, Kuwait, Liechtenstein, the Netherlands, Norway, Saudi Arabia, Sweden, and Turkey.
Insulin pumps are continuously used devices woven into daily life, and identifying affected lots requires action on the user side — which is reflected in the record showing that the firm's initial notification method was a press release.
Why it matters
For devices woven into daily life such as insulin pumps, a failure that looks like normal operation is harder to detect — and therefore deeper in impact — than one that stops the device outright. This case saw a manufacturing-origin defect spread across roughly 290,000 units and more than 20 countries. Being able to identify affected stock instantly by UDI and lot, having notification paths that reach users directly (here, a press release), and keeping an alternative delivery method available are the practical safeguards for both manufacturers and clinical teams.
FAQ
What is a cannula?
Why is this the most serious classification?
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Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2605-2026