Tandem Diabetes Care recalls

Tandem Diabetes Care has 12 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 1 Apr 2026. 11 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is labeling errors.

Total recalls12since 2014

Last 12 months4reported

Class I542% of total

Ongoing11latest 1 Apr 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 2Apr 0 0 0Jul 0 0 2Oct 1 0 0Jan '26 0 0 1Apr 0 0 0Jul 0 0

Severity split

Class I 5 42%Class II 7 58%Class III 0 0%

Why tandem diabetes care is recalled

Product types

Insulin Pumps & Glucose Monitors1083%
Infusion Pumps217%

By year

202618%
2025542%
202418%
2022325%
201818%
201418%

Ongoing tandem diabetes care recalls

11 active

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Device	CLASS II	Tandem pumps are battery-operated infusion pumps capable recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
12 Nov 2025Device	CLASS I	Tandem Mobi Insulin Pump: Description recalled by Tandem Diabetes Care	Tandem Diabetes Care	Device Malfunction	52 states
29 Oct 2025Device	CLASS II	t:slim X2 insulin pump with Interoperable Technology recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
1 Oct 2025Device	CLASS II	t:slim X2 Insulin Pump with Interoperable Technology recalled	Tandem Diabetes Care	Lead & Heavy Metals	Nationwide
23 Apr 2025Device	CLASS I	Tandem Mobi Insulin Pump with Interoperable Technology recalled	Tandem Diabetes Care	Labeling Errors	29 states
23 Apr 2025Device	CLASS I	t:slim X2 Insulin Pump with Interoperable Technology recalled	Tandem Diabetes Care	Labeling Errors	29 states

All tandem diabetes care recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Device	CLASS II	Tandem pumps are battery-operated infusion pumps capable recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
12 Nov 2025Device	CLASS I	Tandem Mobi Insulin Pump: Description recalled by Tandem Diabetes Care	Tandem Diabetes Care	Device Malfunction	52 states
29 Oct 2025Device	CLASS II	t:slim X2 insulin pump with Interoperable Technology recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
1 Oct 2025Device	CLASS II	t:slim X2 Insulin Pump with Interoperable Technology recalled	Tandem Diabetes Care	Lead & Heavy Metals	Nationwide
23 Apr 2025Device	CLASS I	Tandem Mobi Insulin Pump with Interoperable Technology recalled	Tandem Diabetes Care	Labeling Errors	29 states
23 Apr 2025Device	CLASS I	t:slim X2 Insulin Pump with Interoperable Technology recalled	Tandem Diabetes Care	Labeling Errors	29 states
15 May 2024Device	CLASS I	t:connect mobile app used in conjunction recalled	Tandem Diabetes Care	Lead & Heavy Metals	Nationwide
5 Oct 2022Device	CLASS II	t:slim X2 insulin pump recalled by Tandem Diabetes Care	Tandem Diabetes Care	Labeling Errors	52 states
5 Oct 2022Device	CLASS II	t:slim X2 insulin pump recalled by Tandem Diabetes Care	Tandem Diabetes Care	Labeling Errors	52 states
22 Jun 2022Device	CLASS II	t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM recalled	Tandem Diabetes Care	Lead & Heavy Metals	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.