Alternate Controller Enabled Insulin Infusion Pump
Omnipod 5 Insulin Pump Recall Summary Certain Omnipod 5 Pods from 49 specific lots have an internal manufacturing defect where the soft cannula (delivery tube) tears, causing insulin to leak inside the pod instead of being delivered to the user. This can result in under-delivery of insulin or complete pump shutdown, which may cause dangerously high blood sugar levels and serious complications including diabetic ketoacidosis. The affected pods are distributed nationwide, and not all defective pods will alert users to the problem.
- Product
- Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
- Reason
- Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity...
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1dfa8713-8007-4961-9a17-5329f7b87fa4