The company identified a manufacturing issue through ongoing product monitoring that could result in insulin under-delivery with the affected current-generation Omnipod 5, previous-generation Omnipod Dash or the prior Omnipod Insulin Management System (Eros).
Insulet said the scope of this action reaches approximately 7 million pods. The company instructs users to identify affected devices and discontinue use.
This issue is separate from the March recall that affected certain Omnipod 5 lots. The FDA identified that recall as its most serious type last month, with 476 medical device reports, 29 serious injuries and no deaths associated with the previous issue. Insulet said it includes certain lots of devices distributed in the U.S. and affected international markets. Pods not included in the affected lots remain safe to use.
According to the Acton, Massachusetts-based company, some of its affected pods may have a small tear in the tubing (cannula) just above the skin. This tear lands between the pod and the point where the cannula enters the body. If this occurs, insulin may leak outside of the device instead of being fully delivered into the body as intended. This may lead to under-delivery of the therapeutic.
Individuals using an affected pod may notice wetness on the skin or pod adhesive or detect the smell of insulin. However, some cases may prove difficult to detect and go unnoticed.
Improper delivery of insulin may lead to high blood glucose levels. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a potentially life-threatening condition.
The scope of the latest Insulet recall
Of the approximately 7 million pods included in the action, approximately 60% have been consumed or are expired. The pods affected by the correction represent approximately 8.5% of the 2025 global Omnipod pod production.
Insulet reports 24 global incidents of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. It reports zero deaths associated with the issue. The issue does not affect integrated continuous glucose monitors (CGMs) or their readings.
According to Insulet, it identified the cause of the manufacturing issue and implemented corrective actions to prevent recurrence. It also said it strengthened its in-process monitoring and quality controls to detect cannula tears of this nature. The company says it is communicating proactively with affected customers and providing clear instructions to help identify affected lots, discontinue use of impacted devices and obtain replacements at no cost.
Insulet says it has sufficient supply to replace affected pods. It expects no disruption to product availability. The company said it has notified the FDA and all other relevant regulatory authorities of its action.
The full list of affected pod lots can be found here.
The analysts’ take
BTIG analysts Marie Thibault, Alexandra Pang and Sam Eiber maintain a “Buy” rating for Insulet despite the latest setback.
The analysts say they held a brief call with management after the announcement. They learned that the company is “focused on making the replacement process as quick and easy as possible for prescribers and patients with added customer support and proactive, reassuring messaging.”
Management also said they expect no impact to Insulet’s 2026 guidance or long-range plan, the analysts say. They also noted an increase in new patient starts following the March correction. Management is prepared for but not expecting a plant inspection in the near-term, the analysts said.
The analysts trimmed their valuation multiple from ~4.5x to ~4x, despite making no changes to their forecast.
“This reduced multiple reflects continued negative investor sentiment and what we perceive to be some risk of reputation damage or increased regulatory scrutiny from this second voluntary MDC,” the analysts said.
