Omnipod 5 Pods
Insulet is recalling Omnipod 5 Pods due to a cannula defect that can cause insulin under-delivery and severe health risks.
Check your Pod lot number against the list provided by Insulet. If you have an affected Pod, stop using it immediately and contact Insulet for a replacement. Monitor your blood glucose levels closely and be prepared to use an alternative method of insulin delivery if you suspect your device is not functioning correctly.
Recall at a glance
- Quantity recalled
- 1,240,115 units
Why it was recalled
Insulet is recalling specific lots of Omnipod 5 Pods distributed nationwide due to a manufacturing defect that can cause an internal soft cannula tear. This tear may lead to insulin leaking into the device, resulting in insulin under-delivery or complete cessation of delivery, which poses a risk of severe hyperglycemia or diabetic ketoacidosis. The affected devices may not always trigger an alarm or alert the user to the failure.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
- UDI-DI
- 10385083000527
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Insulet Corporation
Editorial summary by Recall Canary · summary updated 2026-06-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification