Insulet Initiates Voluntary Medical Device Correction For Certain Omnipod® Pods In The U.s. And Affected International Markets

Summary Insulet Corporation is voluntarily correcting certain lots of Omnipod 5, Omnipod DASH, and Omnipod Eros insulin pump pods in the U.S. and some international markets due to a manufacturing issue. The correction affects specific production batches of these insulin delivery devices. Users of these pod models from the affected lots are impacted by this correction.

Reason

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation, Inc. (NASDAQ: PODD) (“Insulet” or the “Company”) today announced a voluntary Medical Device Correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue, identif

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-05-26

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/df0d831e-696c-4f5c-86b4-3892977acc12