Z-0423-2023Class II

Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM...

Name: Z-0423-2023 Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM...
Creator: Insulet Corporation
Published: 2022-11-14
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2022-11-14 / Open, Classified / root cause: design

FDA source

Insulet Corporation began a recall of Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu... on 2022-11-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0423-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-14
Posted: 2022-12-07
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
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
Reason for recall: 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 tag: design
FDA 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 in commerce: 129,086
Distribution: Domestic distribution nationwide.
Product codes and lots: ALL serial numbers/ controller lots are currently in scope of this recall

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0423-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0423-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-07

Product code QFG

K203768Class IIOmnipod 5 ACE Pump (Pod)Insulet Corporation / cleared 2022-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)