Omnipod 5Recalls & reported problems across all models

We found 8 models of Omnipod 5 by Insulet Corporation in the FDA's device registry (GUDID). Together they are named in 136,063 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2022 and Sep 30, 2026 — classified as 100 deaths, 14,724 injuries, 121,236 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (64,011 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Omnipod 5 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 20, 2026Open, Classified

   External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.

   Z-2603-2026 · Root cause: Process design · names 3 of these models · Recall details · FDA record ↗

2. Mar 12, 2026Open, Classified

   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.

   Z-1797-2026 · Root cause: Process design · Recall details · FDA record ↗

3. Sep 11, 2025Open, Classified

   The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.

   Z-0132-2026 · Root cause: Software design · Recall details · FDA record ↗

4. May 23, 2025Open, Classified

   Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

   Z-2016-2025 · Root cause: Software design · Recall details · FDA record ↗

5. Feb 28, 2023Open, Classified

   An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the volume of inquiries Insulet was receiving from customers, an email was sent to all phone control users and the cause of the error message was resolved by reverting to prior certificates on the Insulet cloud to secure communications between the Omnipod 5 App sotware and the Insulet Cloud. This issue was limited to only certain compatible Android smartphones and did not affect the Omnipod 5 Pods or the dedicated locked-down Controller provided by Insulet. All other Omnipod 5 users were still able to manage their insulin with the device without use of the smartphone app and affected users were able to switch to the locked-down control provided to all users when they initiated the device during the time the App was unavailable to them. Further, the Omnipod itself continued to deliver insulin as per its pre-programmed settings so although affected users who did not have the locked-down controller readily available may not have been able to command insulin boluses during this time, they continued to receive basal insulin without interruption. Lastly, users of the Omnipod 5 were advised during training to always have backup supplies ready in the event of a device malfunction which would include alternative means to deliver insulin subcutaneously until the issue is resolved to minimize disruption to their insulin regimen. There were 2,168 complaints received out of 7,838 users with the Android compatible smartphones affected and 9 MDRs were submitted, however, there were no serious injuries reported or reports of erroneous results as the primary issue was a delay in therapy. This defect cannot cause false results that could negatively impact patients.

   Z-2618-2023 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported Omnipod 5 problems

Omnipod 5 models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Omnipod 5 Pod POD-BLE-H1-520

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall75 deaths71,459 reports
• Omnipod 5 Pod POD-OMNI-I1-6720

  Alternate Controller Enabled Insulin Infusion Pump
  2 recalls11 deaths61,198 reports
• Omnipod 5 Controller PDM-H001-G-XX

  Alternate Controller Enabled Insulin Infusion Pump
  14 deaths2,116 reports
• Omnipod 5 Pod POD-OMNI-I1-6220

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall1,191 reports
• Omnipod 5 Controller APP 1.0

  Alternate Controller Enabled Insulin Infusion Pump
  1 recall48 reports
• Omnipod 5 Controller APP M009-2S-AP

  Continuous Glucose Monitor Informed Insulin Dose Calculator
  1 recall20 reports
• Omnipod 5 Controller APP M009-S-AP

  Continuous Glucose Monitor Informed Insulin Dose Calculator
  1 recall15 reports
• Omnipod 5 Controller APP M009-3P-AP

  Alternate Controller Enabled Insulin Infusion Pump
  16 reports

Recent Omnipod 5 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: Hyperglycemia

  MAUDE report 50955185 ↗
• InjurySep 30, 2026Loss of or Failure to Bond; Insufficient Device Problem Information

  Patient problems: Eczema

  MAUDE report 50955170 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Skin Infection

  MAUDE report 50955161 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Skin Infection

  MAUDE report 50955159 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Extreme Exhaustion; Headache; Hyperglycemia; Malaise

  MAUDE report 50955140 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Polydipsia; Urinary Frequency / Polyuria; Vomiting

  MAUDE report 50955137 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: Hyperglycemia

  MAUDE report 50955123 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Erythema; Pain; Skin Infection; Swelling/ Edema

  MAUDE report 50955100 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Fluid/Blood Leak; Material Twisted/Bent

  Patient problems: Hyperglycemia

  MAUDE report 50954897 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak; Material Twisted/Bent

  Patient problems: Hyperglycemia

  MAUDE report 50954863 ↗
• MalfunctionSep 30, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954827 ↗
• MalfunctionSep 30, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954819 ↗
• MalfunctionSep 30, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954795 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement

  Patient problems: Hyperglycemia

  MAUDE report 50954736 ↗
• MalfunctionSep 30, 2026Material Twisted/Bent

  Patient problems: Hyperglycemia

  MAUDE report 50954726 ↗

Other Insulet Corporation products

• Omnipod 5 Pod3 models · 133,848 reports · 2 recalls
• Omnipod4 models · 58,769 reports · 1 recall
• Omnipod DASH2 models · 57,338 reports · 2 recalls
• Omnipod 5 Controller APP4 models · 99 reports · 3 recalls