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.

Informational only. Not legal, financial, or medical advice.