---
title: "Omnipod: Device intended for the subcutaneous delivery of insulin into a patient — FDA announcement May 26, 2026 | Is It on Recall"
description: "Manufacturing issue that could result in under delivery of insulin"
url: https://isitonrecall.com/recall/fdapress-d93b8f9dd2907b76-omnipod-device-intended-for-the-subcutaneous-delivery-of-insulin-into-a-patient/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-pods-us-and-affected)

## 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.

## What to do next

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. 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-podders. Customers outside the U.S. should visit www.omnipod.com and click the banner at the top of the page for more information.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-pods-us-and-affected)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Insulet Corporation, Inc. records](https://isitonrecall.com/brand/insulet-corporation-inc/)