Omnipod 5 Pods Recall: Internal Tubing Tear, Insulin Leakage, and What to Do

Published by Justpoint Inc.

If you wear an Omnipod 5 insulin pump, a manufacturing defect in certain Pods may result in insulin leaking inside the device instead of being delivered into your body — and the Pod can do this without sounding an alarm. That means your pump may appear to be working normally while you are actually receiving less insulin than your settings call for, putting you at risk of markedly elevated blood sugar, ketones, and diabetic ketoacidosis (DKA).

On March 12, 2026, Insulet Corporation, the manufacturer of the Omnipod 5, initiated a voluntary Medical Device Correction for specific lots of Omnipod 5 Pods sold in the United States. The U.S. Food and Drug Administration (FDA) escalated the action to a Class I recall — the agency’s most serious classification — on April 29, 2026. At the time of the initial March 12 announcement, Insulet reported 18 serious injuries linked to the defect. By April 17, 2026, that count had grown to 476 serious injuries. No deaths have been reported.

This article explains what the Omnipod 5 is, what the tubing tear does, how to check whether your specific Pods are affected, what symptoms should prompt immediate action, and where to verify everything for yourself.

What the Omnipod 5 is

The Omnipod 5 is a tubeless, wearable insulin pump made by Insulet Corporation (Acton, Massachusetts). It is one of the most widely used “patch pump” systems in the United States for people with type 1 diabetes and, more recently, insulin-requiring type 2 diabetes. A single Pod holds 85–200 units of U-100 rapid-acting insulin, is worn directly on the skin for up to three days, and delivers insulin through a small cannula automatically inserted into the subcutaneous tissue. The Pod communicates wirelessly with a controller (a dedicated handheld device or a compatible smartphone) and, in automated mode, with a continuous glucose monitor.

The current-generation Omnipod 5 ACE Pump received FDA 510(k) clearance on January 27, 2022, under premarket notification number K203768. The FDA classifies it as a Class II device — “alternate controller enabled infusion pump” — under regulation 21 CFR 880.5730. The predicate device for the clearance was the earlier Omnipod DASH System Pod (K191679).

The defect, in plain language

The defect is a small tear in the internal tubing inside the Pod — the tubing that carries insulin from the Pod’s reservoir to the cannula in your skin. When the tubing is torn, insulin may leak out inside the sealed plastic housing of the Pod instead of being delivered into your body.

Three features of this defect are important to understand:

1. It can be silent. A leak inside the Pod typically does not trigger an alarm or an alert on your controller. The Pod’s drive mechanism continues to advance as scheduled. From the outside, the pump appears to be working normally.
2. You may not see anything. Because the leak is internal, you usually cannot tell by looking at the Pod that insulin is escaping. The cannula site may look fine. The Pod’s housing may look fine.
3. The under-delivery can be partial or near-total. Depending on the size and location of the tear, you may receive a fraction of your intended insulin, or almost none of it.

The clinical consequence is insulin under-delivery, which is associated with rising blood glucose. Sustained high blood glucose may progress to diabetic ketoacidosis (DKA), a medical emergency that can require hospitalization and, if untreated, can be fatal.

What the recall covers

The defect was traced to a specific manufacturing problem. According to Insulet, the affected Pods represent roughly 1.5 percent of the annual global Omnipod 5 Pod production volume — a meaningful share given how many users rely on the system.

• March 12, 2026 — Insulet sent letters to affected customers, identified the initial list of affected lots, and asked users to stop using Pods from those lots. The company opened a recall lookup page at https://omnipod.com/check-pods and a dedicated information page at https://omnipod.com/mdc-3-26 (“Urgent Medical Device Correction”).
• April 10, 2026 — Insulet expanded the affected-lot list to include additional Pods, including some that had already passed their expiration date, and provided additional language clarifying that the defect may not be detectable by the user.
• April 29, 2026 — The FDA designated the action a Class I recall, reflecting that use of the affected Pods could cause serious injury or death.

The full, current list of affected lot numbers is maintained by Insulet on its check-pods page and on the FDA recall page. The Class I designation appears in the FDA database under the recall record for “Omnipod 5 ACE Pump.”

Reported harm

Insulet’s adverse-event reports tied to the tubing defect have grown as the recall has progressed:

• 18 serious injuries — reported as of March 12, 2026 (the initial recall date).
• 29 serious adverse events — confirmed in Insulet’s April 10, 2026 communication.
• 476 serious injuries — reported as of April 17, 2026.
• 0 deaths — reported across all updates.

Reported injuries have included hospitalizations for hyperglycemia and diabetic ketoacidosis. Children and adolescents — who make up a substantial share of the Omnipod 5 user base — have been among the affected patients in publicly reported cases.

Adverse-event counts from FDA recall records and Insulet reporting reflect reported associations and are subject to reporting bias; they do not establish device-level causation for individual events.

A note on the supplier — Unomedical

Insulin pump components, including tubing and infusion-set parts, are typically supplied by specialized subcomponent manufacturers. Unomedical (a ConvaTec Group company) is one of the largest suppliers of insulin infusion-set components for the diabetes-pump industry. In January 2026, the FDA issued a Warning Letter to Unomedical Device S.A. de C.V. (a ConvaTec company) regarding its Reynosa, Mexico, manufacturing facility, citing leaking infusion sets, mishandled complaint investigations (including more than 41,000 complaints closed without investigation between June 2023 and June 2025), and delayed corrective actions. The Warning Letter named infusion sets used with pumps from Medtronic, Tandem, and Beta Bionics; Insulet’s Omnipod 5 was not named in that 2025 Warning Letter, and Insulet has stated that the March 2026 Pod tubing recall was identified through its own internal monitoring. Whether and to what extent any Unomedical-supplied component is implicated in the Omnipod 5 defect has not been publicly confirmed by either company as of this writing.

How to check whether your Pods are affected

Four pathways can help you determine whether the Pods you are using or have on hand are subject to the recall.

1. Find the lot number on your Pod packaging or on the Pod itself. The lot number appears in three places:

   • On the side of the 5-Pack Pod box (all five Pods in a single box share the same lot number).
   • On the lid of each individual Pod tray.
   • On the flat bottom of the Pod itself.

2. Enter that lot number at omnipod.com/check-pods. The site will tell you whether the lot is included in the recall and, if it is, will let you request free replacement Pods.

3. Call the Insulet Product Support recall line at 1-800-641-2049. The line is staffed 24 hours a day, 7 days a week, specifically for this recall. A representative can check your lot numbers against the affected list and arrange replacements.

4. Contact your healthcare provider. Your endocrinologist, diabetes-care team, or other healthcare provider can help you determine whether your Pods may be affected and advise you on appropriate next steps.

If a Pod from an affected lot is currently on your body, Insulet’s published recall guidance is to discontinue use and replace it with a Pod from an unaffected lot. Insulet’s notice indicates this should not wait until the Pod completes its three-day cycle. Follow this guidance in conjunction with your healthcare provider’s instructions.

Warning signs that should prompt immediate action

Because the leak inside the Pod is silent, you cannot rely on alarms to alert you that your pump has stopped delivering insulin. Watch for the clinical signs of insulin under-delivery:

• Unexpectedly high blood glucose readings despite recent boluses — especially repeated readings that do not respond to correction doses.
• Ketones on a urine or blood ketone test (ask your care team for your provider-recommended ketone threshold (commonly cited values are around 0.6 mmol/L blood beta-hydroxybutyrate, but yours may differ)).
• Frequent urination and excessive thirst.
• Unexplained or rapid weight loss.
• Nausea, vomiting, or abdominal pain.
• Fruity- or acetone-smelling breath.
• Rapid or deep breathing, fatigue, confusion, or sleepiness — these are signs of progressing DKA and warrant urgent medical care.
• An apparently “normal” Pod that does not seem to be doing anything. If your blood sugar will not come down despite what looks like normal pump function, change the Pod and contact your diabetes-care team.

These are the standard warning signs of DKA, and they should be acted on the way you would act on any DKA risk: confirm with a meter and ketone test, take corrective steps, and contact your provider.

What to do if you suspect a faulty Pod

1. Replace the Pod per Insulet’s recall guidance. Insulet recommends replacing the current Pod with one from a lot that is not on the recall list; confirm the steps with your diabetes-care team if you are unsure.
2. Follow your prescriber-set backup insulin plan. Have a pen or syringe with rapid-acting insulin available so you can follow the backup plan your prescriber set (typically a correction dose by pen or syringe at your individual correction factor) while your blood sugar is high and you sort out the pump situation. If you do not currently have a backup, ask your diabetes-care team to prescribe one — every Omnipod user should have one.
3. Increase blood-glucose monitoring. Do not rely solely on your continuous glucose monitor; use manual finger sticks to confirm your exact blood sugar level if your readings are fluctuating.
4. Check for ketones if your blood glucose is persistently elevated — commonly at or above 200 mg/dL in general adult guidance — or if you feel physically unwell.
5. Call Insulet at 1-800-641-2049 to report the suspected failure and arrange replacement Pods.
6. Contact your diabetes-care provider. They can help you adjust insulin doses, evaluate symptoms, and decide whether you need to be seen.
7. Go to the emergency department if you have signs of DKA — vomiting, deep rapid breathing, abdominal pain requiring urgent evaluation, confusion, or significantly elevated ketones.

Reporting a problem to the FDA

You — or a family member or caregiver — can report any device-related harm directly to the FDA’s MedWatch program. Patient and caregiver reports are an important part of the data the FDA uses to monitor device safety and to identify problems that may require further action.

• Online: www.fda.gov/medwatch
• Phone: 1-800-FDA-1088 (1-800-332-1088)

Filing a MedWatch report does not initiate a legal claim and is not a substitute for medical care, but it does help the FDA detect patterns of harm. Your treating clinician can also file on your behalf.

Regulatory and legal context

Insulet has had prior recalls in the Omnipod product line, illustrating that the company’s recall and correction processes have been exercised before:

• In November 2024, the FDA designated as Class I a recall of certain Omnipod DASH Personal Diabetes Manager (PDM) controllers for battery swelling, leakage, and overheating — including reports of fires — affecting 248,288 devices distributed between July 2018 and August 2022.
• The Omnipod 5 controller has been the subject of a separate correction for charging-port and cable overheating that resulted in melted or deformed components.
• The Omnipod 5 Android app was the subject of a software-error recall related to bolus entries below 1 unit.

The current March 2026 Pod tubing recall is the first Class I action specifically against the Omnipod 5 Pod hardware. It is a regulatory action indicating that the manufacturer has identified a defect posing a meaningful risk to health. The recall reflects an aggregated regulatory determination based on reported associations rather than an adjudicated causal finding for any individual case. It is evidence of a recognized safety concern, not by itself a determination of legal liability.

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Related articles

If you are researching this device, these related Justpoint patient guides may also be relevant:

• iLet® ACE Pump (Beta Bionics): Safety Alerts, FDA Warning Letter, and What Patients Should Watch For — iLet ACE Pump — another automated insulin-delivery system with safety alerts
• True Metrix Blood Glucose Monitoring Systems: The E-5 Error Code, the 2026 Class I Recall, and What Patients Need to Know — True Metrix blood-glucose meters — used by many insulin-pump users for backup monitoring

Sources and how to verify

• FDA — “Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods” (FDA medical device recalls and early alerts page) — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219130. Confirms Class I designation (April 29, 2026), 476 serious injuries as of April 17, 2026, no deaths, and the tubing-tear defect description.
• FDA — “Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.” (FDA Recalls, Market Withdrawals & Safety Alerts page, March 12, 2026) — https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-5-pods-us. Confirms initial recall date, defect description, 18 serious injuries at initial announcement, no deaths, and the lookup at omnipod.com/check-pods.
• Insulet — “Urgent Medical Device Correction” at https://omnipod.com/mdc-3-26 and recall lookup at https://omnipod.com/check-pods. Includes affected lot numbers, expiration dates, and replacement-request workflow.
• FDA 510(k) record K203768 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K203768. Confirms Omnipod 5 ACE Pump clearance on January 27, 2022; classification Class II; regulation 21 CFR 880.5730; predicate K191679.
• FDA Class I Device Recall — “Omnipod 5 ACE Pump” (FDA AccessData CDRH recall database, record id 219130) — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219130. The Class I recall record corresponding to the March 2026 tubing tear correction.
• Insulet Product Support — recall hotline: 1-800-641-2049 (24/7, dedicated to this Medical Device Correction).
• Insulet general customer care: 1-800-591-3455.
• FDA Warning Letter to Unomedical Device S.A. de C.V. (issued January 2026; reported by MedTech Dive) — https://www.medtechdive.com/news/fda-warns-insulin-infusion-set-maker-unomedical-over-leaks-mishandled-comp/813503/. Context only — the Omnipod 5 Pod recall is a separate action; the Warning Letter did not name Insulet.
• FDA MedWatch (adverse-event reporting): https://www.fda.gov/medwatch or 1-800-FDA-1088.

This article was published by Justpoint Inc. The information provided is for educational purposes, does not constitute medical or legal advice and is based on publicly available research and regulatory communications. Findings may vary depending on individual circumstances, device type, and clinical context. If you have a medical device that may be affected, please consult your physician. If you believe you may have a legal claim, please consult a qualified attorney.

Justpoint Inc. supports Justpoint Law (Justpoint PLLC) by providing operational and administrative services. All legal services are provided by Justpoint Law, and any client-related communications are made on its behalf.