Recall archive / FDA company announcement
Omnipod: Alternate controller enabled insulin infusion pump — FDA announcement Mar 13, 2026
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Mar 13, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Alternate controller enabled insulin infusion pump
- Reason
- Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended.
- Classification
- Not supplied
- Recalling firm
- Insulet Corporation
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 914430f969aed6ea
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Customers can visit omnipod.com/check-pods to check lot numbers and request replacement Pods at no cost; Customers should visit omnipod.com/check-pods 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Mar 13, 2026
- Company announcement date
- Mar 12, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.