fda_recall · device_recall · critical
Insulet Corporation — Class I recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
- Event date
- 2026-04-22 00:00:00Z
- Observed
- 2026-07-09 22:53:03Z
- Source ID
- Z-1797-2026
- Payload hash
- de8c943912cb7987d96266f1…
Summary
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 cannul… Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.

