Omnipod 5 insulin pods from 49 lots have torn internal cannulas
Omnipod 5 Pods from 49 lots have an internal soft cannula tear that lets insulin leak inside the Pod instead of being delivered. 1,240,115 units are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; the source names death only as a potential consequence of the mechanism rather than a reported death, so it does not escalate to Critical.
Plain-English summary
Omnipod 5 Pods, model/catalog number PT-001662 ASM 5PK Pod STRL OPS G6G7, UDI-DI 10385083000527, are being recalled. The action covers 1,240,115 units across 49 lot codes listed in the recall notice.
Due to a manufacturing defect, affected Pods 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. The defect results from damage to the unexposed portion of the soft cannula during manufacturing, producing 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 circuitry and causes an electrical short. The FDA classified the action as Class I, its most serious classification.
According to the manufacturer, under-delivery or cessation of insulin puts users at risk of hyperglycemia and its complications, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome or death, and users may require hospitalisation or medical intervention. Not all devices with the defect will issue an alarm. Where there is enough leakage to short the circuitry, the Pod issues a Hazard Alarm that stops all insulin delivery and prompts the user to replace it. Distribution was nationwide.
Users should check their Pod lot codes against the recall notice and follow the instructions issued by the manufacturer. Anyone whose glucose is trending high without explanation should follow their care plan and contact their healthcare provider; do not stop insulin therapy without medical advice.
The recalled product
- Product
- Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
- Manufacturer
- Insulet Corporation
- Category
- Medical Device — Insulin pump
- Hazard
- under-delivery
- cannula-tear
- class-i
- hyperglycemia-risk
- insulin-delivery
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- PH1U03282511
- PH1U03282522
- PH1U03312511
- PH1U03312521
- PH1U04012511
- PH1U04012521
- PH1U05052511
- PH1U08162531
- PH1U08182531
- PH1U08182541
- PH1U09242511
- PH1U09242521
- PH1U09242531
- PH1U09252521
- PH1U09252531
- PH1U10152541
- PH1U10162531
- PH1U10162541
- PH1U10172531
- PH1U10172541
Distribution
Distributed nationwide across the United States.
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