Insulet recalls
8 official recalls and safety alerts involving Insulet since 2022-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Insulet or the relevant agency.
- 2026-07-08
USInsulet Corporation recalls Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump…
FDA · DeviceInsulet CorporationWorldwide distribution - US Nationwide and the countries of Austria,…Official notice →- 2026-04-22
- US
Insulet Corporation recalls Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus…
- 2025-10-22
- US
Insulet Corporation recalls The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field…
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a…
- 2025-07-02
- US
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product…
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if…
FDA · DeviceInsulet CorporationUS market only- Although there are 122823 downloads of the application, our…Official notice → - 2024-01-10
- US
Insulet Corporation recalls Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package…
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on…
FDA · DeviceInsulet CorporationWorldwide distribution - US Nationwide and the countries of Germany and UK.Official notice → - 2023-09-27
- US
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which…
- 2022-12-14
- US
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor,…
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…
- 2022-11-23
- US
Insulet Corporation recalls 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM…
The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a…
FDA · DeviceInsulet CorporationWorldwide Distribution: US nationwide, Canada, Europe, Australia, and the…Official notice →