Recall archive / FDA company announcement
Omnipod: Device intended for the subcutaneous delivery of insulin into a patient — FDA announcement May 26, 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 May 26, 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
- Device intended for the subcutaneous delivery of insulin into a patient
- Reason
- Manufacturing issue that could result in under delivery of insulin
- Classification
- Not supplied
- Recalling firm
- Insulet Corporation, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- d93b8f9dd2907b76
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Customers should visit 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. |
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
- May 26, 2026
- Company announcement date
- May 26, 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.