PODD 8-K filed 2026 · insiderdelta

Item 7.01

Regulation FD Disclosure

On May 26, 2026, Insulet Corporation (the “Company”) issued a press release announcing a voluntary Medical Device Correction for specific lots of Omnipod® products due to a manufacturing issue identified through ongoing product monitoring. A copy of the press release is furnished herewith.

This action is separate from the Company’s March 12, 2026 voluntary Medical Device Correction.

The two actions involved different manufacturing processes, both of which were related to cannula tears associated with cannula handling at the Company’s Acton, Massachusetts facility. In both cases, the Company identified the cause and implemented corrective actions designed to prevent recurrence. All product in scope of this correction was manufactured before the enhanced quality controls implemented in connection with the prior action were put in place.

Approximately 7 million Pods are included in scope, of which approximately 60% have been consumed or expired. Based on its current assessment, the Company does not anticipate disruption to customer shipments, product availability or new customer starts.

While it is too early to ascertain the exact cost of this voluntary medical device correction, the Company expects to incur up to $50 million of costs associated with this correction in 2026, which will be excluded from adjusted results. Accordingly, the Company does not expect an impact to its long-term growth profile and is not changing its previously issued 2026 guidance as a result of this voluntary action.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability of that section. The information in this Current Report shall not be incorporated by reference into any filing or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing or document.

Forward-Looking Statements

This current report on Form 8-K includes certain forward-looking statements within the meaning of the Private Litigation Securities Reform Act of 1995, as amended. Forward-looking statements relate to future events, including statements concerning the Company’s plans or expectations regarding any voluntary medical device correction, effects of any voluntary medical device correction on the Company’s business, operations, and financial performance or guidance, and expected costs of any voluntary medical device correction, and involve known and unknown risks, uncertainties and other factors, many of which are beyond the Company’s control, that may cause the actual results, performance or achievements of the Company to be materially different from its current expectations, assumptions, plans, guidance, estimates and projections, including (but not limited to) the financial, operational, and reputational impact and costs of any voluntary medical device correction, future actions by the FDA and other regulatory bodies, the possibility that any voluntary medical device correction could subject the Company to disputes, claims or proceedings that may adversely affect its business and financial operation and other factors detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended December 31, 2025. The Company encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this report. The forward-looking statements made in this report are made only as of the date of this report, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances except as required by applicable law.
PODD Insulet Corp - 8-K

Item 7.01 - Regulation FD Disclosure

Item 9.01 - Financial Statements and Exhibits
