Stop using now Medical device recall · FDA · Published March 12, 2026

Insulet Omnipod 5 Pods Recall: Internal Leak Risk from Manufacturing Defect

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1797-2026Medical device Insulet ›

Stop using this now

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.

Take action

Contact the company

Recalling firmInsulet Corporation50 & 100 Nagog Park · Acton, MA 01720-3440

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/49740-insulet-omnipod-5-pods-recall-internal-leak-risk-from-manufacturing.

Source Summary by GovInfoNow · govinfonow.com/recall/49740-insulet-omnipod-5-pods-recall-internal-leak-risk-from-manufacturing · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1797-2026

Cite this page

“Insulet Omnipod 5 Pods Recall: Internal Leak Risk from Manufacturing Defect.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49740-insulet-omnipod-5-pods-recall-internal-leak-risk-from-manufacturing. Based on FDA recall #Z-1797-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1797-2026%22&limit=1).

The FDA announced on March 12, 2026, that Insulet Corporation is recalling Omnipod 5 Pods due to a manufacturing defect causing insulin leakage. Owners should contact the company for a replacement, according to the FDA.

How to tell if you have it

Brand: Insulet
Product: Omnipod 5 Pods
Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
UDI-DI: 10385083000527
Lot Codes: PH1U02252541, PH1U03282511, PH1U03282522, PH1U03312511, PH1U03312521, PH1U04012511, PH1U04012521, PH1U05052511, PH1U08162531, PH1U08182531, PH1U08182541, PH1U09242511, PH1U09242521, PH1U09242531, PH1U09252521, PH1U09252531, PH1U10152541, PH1U10162531, PH1U10162541, PH1U10172531, PH1U10172541, PH1U10182531, PH1U10182541, PH1U10202511, PH1U10202521, PH1U10202531, PH1U10202541, PH1U10212531, PH1U10212541, PH1U10222531, PH1U10222541, PH1U10232531, PH1U10232541, PH1U10242521, PH1U10242531, PH1U10242541
Units affected: 1,240,115

The hazard

The defect involves an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user. This can cause pump under-delivery or cessation of insulin delivery, putting users at risk of hyperglycemia, diabetic ketoacidosis (DKA), or death. Not all devices with the defect will issue an alarm.

Context

GovInfoNow's records show Insulet Corporation has 11 other recalls on record since 2018-12-18. Other recent recalls of similar products include Insulet Omnipod Eros Pod Recall (2026-05-20), Insulet Omnipod 5 App Recall (2025-09-11), and Insulet Omnipod 5 iOS App Recall (2025-05-23). FDA's MAUDE device-report database contains 106,945 reports naming Omnipod 5 received since March 2025, including 11,434 marked serious and 114 listing a death. Other recent recalls of similar products include Medtronic MiniMed 780G Insulin Pump Recall (2026-07-13), Medtronic MiniMed 640G Insulin Pump Recall (2026-07-13), and Medtronic MiniMed 720G Insulin Pump Recall (2026-02-13).

How to tell if you have this one

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.

Brand
Insulet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using the Pod
Immediately stop using the affected Omnipod 5 Pod to prevent insulin under-delivery or pump shutdown.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 41 days after the firm started it.

Mar 12, 2026Firm started the recall
Apr 10, 2026FDA classified it Class I
Apr 22, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49740-insulet-omnipod-5-pods-recall-internal-leak-risk-from-manufacturing">Insulet Omnipod 5 Pods Recall: Internal Leak Risk from Manufacturing Defect (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1797-2026 (March 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1797-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.