FDA Medical Device Recalls (openFDA)
Insulet Corporation: Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
- Recall number
- Z-0423-2023
- Recalling firm
- Insulet Corporation
- Product
- Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
- Status
- Open, Classified
- Initiated
- 2022-11-14
- Posted
- 2022-12-07
- Terminated
- not on file
- Reason
- The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.
- Root cause
- Device Design
- Action
- On November 14, 2022, the firm initiated their Press Release at https://investor.insulet.com/news-releases/news-release-details/insulet-issues-nationwide-voluntary-medical-device-correction and notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to monitor their Omnipod 5 Controller for the following issues: - Charging port or charging cable appears melted, deformed, or discolored - Controller experiences extreme overheating (uncomfortable to hold) or emits an odor while charging If customers experience any of the issues above, they should disconnect the charger from the power outlet and do NOT charge the Omnipod 5 Controller. Promptly contact Insulet s dedicated Customer Care team specifically trained to help you at 1-800-641-2049 to request a replacement device. If you have a compatible Android smartphone (please see omnipod.com/compatibility), you may want to switch to using the Omnipod 5 App on your smartphone. Customers were provided with additional precautions to take to continue use of the device.
- Quantity
- 129,086
- Distribution
- Domestic distribution nationwide.
- Lot, serial or model codes
- ALL serial numbers/ controller lots are currently in scope of this recall
- 510(k) numbers
- ["K203768"]
- PMA numbers
- not on file
- Product code
- QFG
- Firm FEI
- 3014585508
- Firm city
- Acton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28