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Insulet Corporation FDA Recalls

11 recalls on file across devices, 6 of them Class I and 9 still open. Matched by name to PODD.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-67Class IMay 20, 2026External soft cannula damage during manufacturing that resul	External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of be	Class IDevices	May 20, 2026
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. Class IMay 20, 2026External soft cannula damage during manufacturing that resul	External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of be	Class IDevices	May 20, 2026
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). Class IMay 20, 2026External soft cannula damage during manufacturing that resul	External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of be	Class IDevices	May 20, 2026
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Class IMar 12, 2026Due to a manufacturing defect, certain Omnipod 5 Pods from 4	Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that res	Class IDevices	Mar 12, 2026
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnifyClass IISep 11, 2025The failure occurs if a user on the Omnipod 5 iOS applicatio	The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field,	Class IIDevices	Sep 11, 2025
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software VersionClass IIMay 23, 2025Insulet Corporation is recalling Omnipod 5 iOS App, due to a	Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not rec	Class IIDevices	May 23, 2025
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 ApClass INov 30, 2023The bolus calculator is not recording the decimal point if i	The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus	Class IDevices	Nov 30, 2023
Omnipod 5 Automated Insulin Delivery SystemClass IIFeb 28, 2023An error message was received when using the Omnipod 5 App o	An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone cont	Class IIDevices	Feb 28, 2023
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-00Class IINov 14, 2022The firm has become aware of an issue with the Omnipod 5 Con	The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and cha	Class IIDevices	Nov 14, 2022
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: AssClass IOct 17, 2022The firm has become aware of PDM battery issues, including b	The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, a	Class IDevices	Oct 17, 2022
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318Class IIFeb 1, 2021Certain foreign user guides include a misprint which could l	Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemi	Class IIDevices	Feb 1, 2021

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