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SEC EDGAR · Company announcement

PODD: Company disclosure

Filed 8-K for an event or period dated 2026-05-26. Company disclosure.

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Became public
May 26, 2026, 4:06 PM EDT
Event / period date
May 26, 2026
Collected
Nov 10, 2026, 9:36 AM EST

Why this is connected

This filing identifies INSULET CORP as the issuer of the security. The company's SEC identifier connects it to PODD.

Source evidence

Read the source excerpt or record
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 

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