FDA Medical Device Recall Alert – Certain Omnipod Pods
| Date: | June 10, 2026 |
| From: | Health Plan of San Joaquin/Mountain Valley Health Plan (“Health Plan”) |
| To: | Health Plan Practitioners, Facilities, and Hospitals |
| Type: | Informational/Educational |
| Subject: | FDA Medical Device Recall Alert – Certain Omnipod Pods |
| Business: | Medi-Cal Managed Care/Medicare Dual Special Needs Program (D-SNP) |
On May 26, 2026, the Food and Drug Administration (FDA) released a recall
announcement on Certain Omnipod Pods.
This is for informational purposes only. You may or may not have administered the medication. Please disregard if you have not been affected by this recall.
For the complete details regarding this recall announcement, please visit the following web link: https://www.fda.gov/safety/recalls-market-withdrawalssafety-alerts/insulet initiates voluntary-medical-device-correction-certainomnipodr-pods-us-and-affected utm_medium=email&utm_source=govdelivery
Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets
Company Announcement
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, identified through ongoing product monitoring, that could result in insulin under delivery.
This action is separate from the voluntary Medical Device Correction issued on March 12, 2026 affecting certain Omnipod 5 Pods in the U.S. and includes certain Pod lots distributed in the U.S. and affected international markets.
Affected Product
Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods
What to Do
Customers should visit https://www.omnipod.com/mdc/check-pod-lot to confirm whether their Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost. A full list of affected lots is available on this site. If a Pod from an affected lot is currently in use, customers should discontinue use and replace it with a Pod from an unaffected lot.
Contact Information
Customers in the U.S. who have questions or need assistance may contact Insulet Product Support at 1-800-641-2049 (available 24/7) or use the live agent chat at www.omnipod.com/current-poddersExternal Link Disclaimer. Customers outside the U.S. should visit www.omnipod.comExternal Link Disclaimer and click the banner at the top of the page for more information.
If you have any further questions, please contact your Provider Services Representative, or call our Customer Service Department at 1-888-936-PLAN (7526). You may also visit https://www.hpsj.com/alerts/ for online access to the documents shared. The most recent information about Health Plan and our services is always available on our website www.hpsj-mvhp.org
