Insulet recalls

Insulet has 21 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 8 Jul 2026. 9 are still ongoing. 5 were reported in the last 12 months.

Total recalls21since 2013

Last 12 months5reported

Class I1048% of total

Ongoing9latest 8 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 1 0Aug 0 1 0Nov 0 0 0Feb 0 1 0May 0 3 0Aug 0 0

Severity split

Class I 10 48%Class II 11 52%Class III 0 0%

Why insulet is recalled

Product types

Insulin Pumps & Glucose Monitors21100%

By year

2026419%
2025210%
202415%
202315%
2022210%
202115%
2020314%
201915%
2015419%
2013210%

Ongoing insulet recalls

9 active

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Omnipod DASH Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Omnipod 5 Pods recalled by Insulet	Insulet	Packaging Defects	Nationwide
22 Apr 2026Device	CLASS I	Omnipod 5 Pods recalled by Insulet	Insulet	Packaging Defects	Nationwide
22 Oct 2025Device	CLASS II	The failure occurs if a user on the Omnipod 5 iOS recalled by Insulet	Insulet	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	The Omnipod 5 iOS App recalled by Insulet	Insulet	Device Malfunction	MA

All insulet recalls, newest first

21 total

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Omnipod DASH Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Omnipod 5 Pods recalled by Insulet	Insulet	Packaging Defects	Nationwide
22 Apr 2026Device	CLASS I	Omnipod 5 Pods recalled by Insulet	Insulet	Packaging Defects	Nationwide
22 Oct 2025Device	CLASS II	The failure occurs if a user on the Omnipod 5 iOS recalled by Insulet	Insulet	Device Malfunction	Nationwide
2 Jul 2025Device	CLASS II	The Omnipod 5 iOS App recalled by Insulet	Insulet	Device Malfunction	MA
10 Jan 2024Device	CLASS I	Omnipod 5 App (on compatible Android smartphones) recalled by Insulet	Insulet	Device Malfunction	Nationwide
27 Sep 2023Device	CLASS II	Omnipod 5 Automated Insulin Delivery System recalled by Insulet	Insulet	Device Malfunction	Nationwide
14 Dec 2022Device	CLASS II	Omnipod 5 Automated Insulin Delivery System Product recalled by Insulet	Insulet	Device Malfunction	Nationwide
23 Nov 2022Device	CLASS I	18239: ASM Omnipod Dash PDM, insulin delivery system recalled by Insulet	Insulet	Packaging Defects	Nationwide
17 Mar 2021Device	CLASS II	Omnipod DASH Insulin Management System User Guide (OUS Only) Product recalled	Insulet	Other	MA
10 Jun 2020Device	CLASS II	Omnipod DASH Insulin Management System (mmol/L configuration) recalled	Insulet	Other	MA
10 Jun 2020Device	CLASS II	Omnipod DASH Insulin Management System (mg/dL configuration) recalled	Insulet	Other	MA
1 Apr 2020Device	CLASS II	Omnipod DASH Personal Diabetes Manager (PDM) recalled by Insulet	Insulet	Labeling Errors	Nationwide
13 Nov 2019Device	CLASS II	Omnipod DASH Insulin Management System, Product recalled by Insulet	Insulet	Labeling Errors	Nationwide
23 Dec 2015Device	CLASS I	OmniPod¿, Insulin Management System (US) recalled by Insulet	Insulet	Other	Nationwide
23 Dec 2015Device	CLASS I	OmniPod¿, Insulin Management System (OUS) recalled by Insulet	Insulet	Other	Nationwide
16 Sep 2015Device	CLASS I	OmniPod¿ Insulin Management System recalled by Insulet	Insulet	Device Malfunction	Nationwide
16 Sep 2015Device	CLASS I	OmniPod¿ Insulin Management System recalled by Insulet	Insulet	Device Malfunction	Nationwide
13 Nov 2013Device	CLASS II	OmniPod Insulin Management System Starter Kit recalled by Insulet	Insulet	Other	Nationwide
13 Nov 2013Device	CLASS II	OmniPod Insulin Management Product Demonstration Kit recalled by Insulet	Insulet	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.