Tandem Diabetes Care recalls

Tandem Diabetes Care has 13 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 7 Oct 2026. 12 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls13since 2014

Last 12 months3reported

Class I538% of total

Ongoing12latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 2 0 0Jun 0 0 0Sep 2 1 0Dec 0 0 0Mar 1 0 0Jun 0 0 0Sep 1 0

Severity split

Class I 5 38%Class II 8 62%Class III 0 0%

Why tandem diabetes care is recalled

Product types

By year

2026215%
2025538%
202418%
2022323%
201818%
201418%

Ongoing tandem diabetes care recalls

12 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Tandem t:slim mobile application t:slim Mobile Application, iOS recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS II	Tandem pumps are battery-operated infusion pumps capable recalled	Tandem Diabetes Care	Device Malfunction	CA
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	Device Malfunction	CA
23 Apr 2025Device	CLASS I	Tandem Mobi Insulin Pump with Interoperable Technology recalled	Tandem Diabetes Care	Labeling Errors	29 states

All tandem diabetes care recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Tandem t:slim mobile application t:slim Mobile Application, iOS recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS II	Tandem pumps are battery-operated infusion pumps capable recalled	Tandem Diabetes Care	Device Malfunction	CA
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	Device Malfunction	CA
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	Device Malfunction	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	Device Malfunction	CA
25 Jul 2018Device	CLASS II	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM recalled	Tandem Diabetes Care	Labeling Errors	23 states
19 Feb 2014Device	CLASS I	T:slim Insulin Delivery System Insulin Infusion Pump recalled	Tandem Diabetes Care	Packaging Defects	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.