Insulet recalls Omnipod 5 Pods with a manufacturing defect causing insulin leaks that may lead to under-delivery or pump shutdown. Affected units include specific model numbers and lots from 2023-2024.
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 in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
Insulet is recalling certain Omnipod 5 Pods due to a manufacturing defect that causes internal insulin leaks. This defect can lead to under-delivery of insulin or pump shutdown, putting users at risk of hyperglycemia, dehydration, and serious complications including diabetic ketoacidosis or death.
The defect causes a tear in the soft cannula during manufacturing, leading to insulin leaking into the Pod instead of being delivered to the user. This can cause pump under-delivery or pump shutdown due to an electrical short from leaked insulin. The leak may result in hyperglycemia, dehydration, or life-threatening conditions like diabetic ketoacidosis.
People using Omnipod 5 Pods with the specific model numbers and lot codes listed in the recall are affected. Those with diabetes who rely on insulin delivery from these devices are most at risk.
Check if your Omnipod 5 Pod has the model number PT-001662 ASM 5PK Pod STRL OPS G6G7 and one of the listed lot codes from the recall. The recall covers specific production lots from 2023-2024.
Immediately stop using the affected Omnipod 5 Pod to prevent insulin under-delivery or pump shutdown.
The recall states that users with the defect may require hospitalization or medical intervention, but the official notice does not specify whether all affected Pods must be replaced.
If there is sufficient leakage to cause a short, the Pod will issue a Hazard Alarm. However, not all devices with the defect will trigger an alarm.
The defect can cause under-delivery of insulin or pump shutdown, leading to hyperglycemia, dehydration, blurred vision, nausea, vomiting, altered mental status, diabetic ketoacidosis, or even death.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-1797-2026 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-1797-2026 from Insulet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
