RecalledThisWeek Search
High risk Medical DevicesClass I

Insulet Omnipod 5 Pod Recall: PT-001662

Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

Updated March 12, 2026

Insulet Corporation is recalling certain Omnipod 5 Pods (model PT-001662) from 49 manufacturing lots because a defect in the soft cannula can cause insulin to leak inside the pod instead of being delivered to the user. Under-delivery or complete stoppage of insulin puts users at serious risk of hyperglycemia, diabetic ketoacidosis (DKA), and in the most severe cases, death.

Is the Insulet Corporation recalled? Yes. This product was recalled by FDA on March 12, 2026. Details below.

What is recalled

Omnipod 5 Pods, Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7, manufactured by Insulet Corporation. Products from 49 specific manufacturing lots are affected (lot numbers not listed in the source record).

Am I affected

You are affected if you use Omnipod 5 Pods with model/catalog number PT-001662 (ASM 5PK Pod STRL OPS G6G7) and your pods come from one of the 49 recalled lots. Check the lot number printed on your pod packaging against the list provided by Insulet Corporation. Important: not all affected pods will trigger an alarm, do not assume you are safe simply because no alert has sounded.

What to do right now

Stop using any pods from the affected lots immediately. Because not all defective pods will sound an alarm, monitor your blood glucose closely for signs of unexplained high readings or symptoms of hyperglycemia (increased thirst, blurry vision, nausea, vomiting, or confusion). If you experience these symptoms, seek medical attention right away. Contact Insulet Corporation to confirm whether your lot numbers are affected and to arrange a replacement. The FDA recall notice is posted at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

The hazard

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.

Brands affected

Insulet Corporation
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1797-2026
Classification
Class I
Recalled
March 12, 2026
Read the official notice

Get free recall alerts

New Medical Devices recalls, the moment they post.

Free forever. Unsubscribe anytime. We never sell your data.

More Medical Devices recalls