Insulet recalls Omnipod pods after insulin delivery fault linked to DKA risk

Image courtesy of Insulet

Insulet has recalled millions of Omnipod pods after identifying a manufacturing fault that could cause insulin under-delivery and increase the risk of dangerous high glucose levels and diabetic ketoacidosis (DKA).

The safety action affects specific lots of Omnipod 5, Omnipod DASH and Omnipod Eros pods. Insulet says a defect in tubing connected to the cannula may allow insulin to leak before it reaches the body, meaning some users may receive less insulin than intended.

For pump users, unexpected insulin under-delivery can become serious quickly. High glucose levels may initially appear as a stubborn correction-resistant high before progressing to ketones or DKA if the problem is not recognised.

The company says it has received reports of serious adverse events linked to the issue, including hospitalisations and DKA. No deaths have been reported.

What is the fault?

According to Insulet, some affected Omnipod pods may develop a small tear in the tubing that carries insulin through the cannula. If that happens, insulin can leak before it reaches the body.

The result is that glucose levels may continue rising despite insulin apparently being delivered through the pod.

Insulet has warned that the issue may not trigger an alarm or alert, meaning users could be unaware that insulin delivery has been reduced.

That detail has caused particular concern because many people rely on pump alerts to identify delivery problems before glucose levels become dangerous.

What Omnipod users should do now

Insulet is advising users to check pod lot numbers immediately using the company's official lot checker and stop using affected pods.

Anyone currently wearing an affected pod should replace it with a pod from a non-affected lot as soon as possible.

Users should watch for:

• persistent unexplained high glucose levels
• repeated correction doses with little effect
• ketones
• nausea or vomiting
• unusual tiredness
• wetness around the pod or adhesive
• the smell of insulin

Anyone experiencing symptoms of DKA or persistent high glucose levels should seek urgent medical advice.

Online reaction: frustration and concern

News of the Omnipod recall quickly spread across diabetes forums, Reddit communities and social media groups used by people with diabetes.

Many users expressed frustration about another Omnipod safety action arriving only months after an earlier recall involving a separate insulin delivery issue.

One Reddit user described the latest announcement as "super annoying", while others reported unexplained highs and pod failures that had already left them questioning whether something was wrong.

Several users discussed discovering the recall only after struggling with persistent high glucose levels.

Others said they were checking every box of pods at home to see whether their supplies were affected.

A recurring concern online has been confidence. For many users, the biggest worry is not simply that a pod can fail, but that insulin under-delivery may not always be obvious until glucose levels have already climbed significantly.

Some users also raised concerns about replacement supplies, customer support wait times and the possibility of entire home stocks containing affected pods.

One parent posting online said the recall email arrived after their child had already experienced prolonged high glucose levels that were difficult to explain.

Another user reported experiencing repeated unexplained highs across multiple pods and questioned whether pods outside the listed lots could also be affected.

While these experiences do not prove additional faults, they highlight the anxiety recalls can create among people who depend on insulin pumps every day.

Why DKA is such a concern

DKA develops when the body does not have enough insulin and starts breaking down fat for energy, producing ketones.

If ketone levels continue rising, DKA can become a medical emergency requiring urgent treatment.

For pump users, insulin delivery failures can sometimes lead to DKA more quickly than with insulin injections because there is no long-acting background insulin present.

That is one reason diabetes teams often advise checking ketones whenever unexplained high glucose levels persist.

Second major Omnipod safety action in 2026

The latest Omnipod recall follows another significant Omnipod safety action announced earlier this year involving a separate tubing-related defect that could also lead to insulin under-delivery.

The earlier action was later classified by the US Food and Drug Administration as a Class I recall, the agency's most serious recall category.

Reuters has reported that Insulet expects the latest correction could cost up to $50 million (over £37 million).

For investors, that figure reflects the scale of the issue.

For users, however, the more important question is whether the pods currently sitting at home are safe to use.

What this means for hybrid-closed loop users

Omnipod 5 has become one of the most widely used hybrid-closed loop systems available in the UK.

The system works with compatible CGMs including FreeStyle Libre 2 Plus, Dexcom G6 and Dexcom G7 to help automate insulin delivery decisions.

Diabetes UK has consistently supported wider access to hybrid-closed loop technology because of its potential to improve glucose management and reduce day-to-day diabetes burden.

Breakthrough T1D UK has also campaigned for broader access to diabetes technology alongside better training and support for people using advanced systems.

Neither organisation appeared to have published a recall-specific statement at the time of writing.

The recall does, however, highlight an important reality of hybrid-closed loop systems. Even the most advanced algorithm still depends on insulin being delivered correctly.

If insulin delivery is interrupted, glucose levels can rise despite the CGM, smartphone app and automated system appearing to function normally.

Overnight concerns and confidence

One theme repeatedly appearing in online discussions is concern about unexplained overnight highs.

For many PWD, overnight periods are when insulin delivery issues can be hardest to spot quickly.

Several users said the recall was worrying because unexpected overnight highs are often one of the first signs that insulin delivery may not be working properly.

That concern helps explain why recalls involving insulin delivery tend to attract such strong reactions across the diabetes community.

The bigger issue: trust in diabetes technology

Insulet has stressed that most Omnipod pods are not affected by the recall and that pods outside the listed lots remain safe to use.

Nevertheless, the reaction online shows how quickly confidence can be shaken when a fault affects a device responsible for delivering insulin around the clock.

For many PWD, insulin pumps are used while sleeping, exercising, travelling, working and driving. Reliability is not simply a convenience issue. It is a safety issue.

The recall also arrives at a time when more people than ever are using hybrid-closed loop systems and relying on connected diabetes technology every day.

As a result, recalls increasingly become conversations not just about manufacturing defects, but about trust, communication and confidence.

What happens next?

Most Omnipod users will never experience this issue.

However, anyone using Omnipod pods should check whether their lot numbers are affected and follow Insulet's guidance.

The immediate priority for users is identifying whether affected pods are in their supplies and obtaining replacements where needed.

Longer term, attention is likely to focus on how quickly replacements are delivered, whether additional affected lots emerge and what steps Insulet takes to restore confidence among users.

The recall is also likely to increase scrutiny of insulin pump reliability more broadly, particularly as hybrid-closed loop systems become more widely used across the UK.

UK users who experience suspected faults or safety issues with insulin pumps, CGMs or other diabetes devices can report them directly to the MHRA through the Yellow Card Scheme. Reports from patients and healthcare professionals help regulators identify potential safety concerns and monitor whether wider action may be needed.

For now, the message is straightforward: check your pod lots, monitor glucose levels closely and seek advice if unexplained highs or ketones develop.

The recall serves as a reminder that while diabetes technology continues to advance rapidly, safe insulin delivery remains the foundation on which every insulin pump and hybrid-closed loop system depends.