FDA Medical Device Recall Alert – Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.
| Date: | March 26, 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 – Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S. |
| Business: | Medi-Cal Managed Care/Medicare Dual Special Needs Program (D-SNP) |
On March 13, 2026, the Food and Drug Administration (FDA) released a recall announcement on Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.
This is for informational purposes only. You may or may not have prescribed the medical device. 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-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-5-pods-us?utm_medium=email&utm_source=govdelivery
Announcement:
Insulet Corporation (NASDAQ: PODD) (“Insulet” or the “Company”) today initiated a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods after identifying a manufacturing issue through its ongoing product monitoring. This action applies to specific identified lots distributed in the United States, and all other Omnipod® 5 Pods and Omnipod® products remain safe to use.
Insulet identified that certain Pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the Pod instead of being fully infused into the body as intended.
If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment.
Devices affected:
- Medical Device Correction impacts only specific lots of Omnipod® 5 Pods
- Customers can visit omnipod.com/check-podsExternal Link Disclaimer to check lot numbers and request replacement Pods at no cost
- All other Omnipod® 5 Pods and Omnipod® products remain safe to use
What to Do:
Customers should visit omnipod.com/check-podsExternal Link Disclaimer to confirm whether their Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost.
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.
Customers 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 omnipod.com/current-podders.
Company Contact Information:
Consumers: Insulet Product Support at 1-800-641-2049
Media: Cristal Downing, Chief Corporate Affairs Officer at pr@insulet.com
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
