Tandem Diabetes Care, Inc. recalls
Every recall we track for Tandem Diabetes Care, Inc. — 13 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Tandem Diabetes Care, Inc. more than tripled in 2025 (6, up from 1 in 2024). 15% rated “stop using now”.
All FDA recall records for Tandem Diabetes Care, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 1 | 0 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 2 | 0 | 0 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 5 | 1 | 0 | 6 |
| 2026 (to date) | 1 | 1 | 0 | 0 | 2 |
What to do if you have a recalled Tandem Diabetes Care, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Tandem Diabetes Care, Inc. recalls
11 shown- Stop using nowMedical device
Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS
Tandem recalls iOS app v2.13 beta due to pairing failures with Abbott FreeStyle Libre 3 Plus sensors, risking glucose monitoring errors.
Tandem Diabetes CareJul 16, 2026 - Use cautionMedical device
Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize
Tandem Diabetes Care recalls pumps with Czech language user guide errors that could lead to unintended insulin delivery and hypoglycemia. Affected pumps have version 7.8.1 and UDI (01)008500066132625.
TandemJan 30, 2026 - Use cautionMedical device
Tandem Diabetes Care, Inc. recalls Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both
Tandem recalls Mobi insulin pumps with software version 7.6.0.3 and 7.7 that may show false vibration motor failure, risking hyperglycemia. Learn what to do.
TandemOct 6, 2025 - Use cautionMedical device
Tandem Diabetes Care, Inc. recalls t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073,
Tandem recalls t:slim X2 and Mobi insulin pumps with Dexcom G7 sensors using specific software versions that may cause unexpected insulin doses leading to low blood sugar.
TandemAug 5, 2025 - Lower riskMedical device
Tandem Diabetes Care, Inc. recalls Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic,
Tandem Diabetes Care, Inc. is a leading manufacturer of insulin pumps and diabetes management solutions. They provide innovative technology to help people with diabetes manage their condition effectively.
Tandem Diabetes Care, Inc.Jul 21, 2025 - Use cautionMedical device
Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Tandem recalls t:slim X2 insulin pumps with app pairing issues when phone uses right-to-left language, risking incorrect blood sugar treatment. Affected units include specific Samsung, Pixel, and Xiaomi models sold with Tandem's mobile app.
TandemJul 3, 2025 - Use cautionMedical device
Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology
Tandem recalls t:slim X2 insulin pumps with software version 7.9 that may incorrectly interpret glucose trends, risking unsafe insulin delivery. Affected units sold with UDI 00389152407012.
TandemFeb 27, 2025 - Use cautionMedical device
Tandem Diabetes Care, Inc. recalls t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Tandem Diabetes Care recalls t:connect mobile app v2.7 for insulin pumps. App crashes cause battery drain and pump shutdown, risking hyperglycemia. Fix by updating to v2.8 or later.
Tandem Diabetes CareMar 5, 2024 - Use cautionMedical device
Tandem Diabetes Care Inc recalls t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim
Tandem Diabetes Care recalls t:slim X2 insulin pumps with specific software versions due to potential hypoglycemia, hyperglycemia, or diabetic ketoacidosis risks from malfunctioning features.
Tandem Diabetes CareMay 24, 2022 - Use cautionMedical device
Tandem Diabetes Care Inc recalls t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Tandem Diabetes Care recalls t:slim X2 insulin pumps with Dexcom G5 or Basal-IQ tech due to potential battery fluctuations causing insulin delivery to stop, risking hyperglycemia.
Tandem Diabetes CareSep 10, 2020 - Stop using nowMedical device
Tandem Diabetes Care Inc recalls t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel
Tandem recalls 55 t:slim G4 insulin pumps due to faulty fuel gauges that may cause inaccurate battery readings and stop insulin delivery.
Tandem Diabetes CareApr 23, 2018
Tandem Diabetes Care, Inc. recall questions
How many recalls has Tandem Diabetes Care, Inc. had?
13 recalls from Tandem Diabetes Care, Inc. are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Tandem Diabetes Care, Inc. recall?
Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS, dated Jul 16, 2026. Every Tandem Diabetes Care, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Tandem Diabetes Care, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Tandem Diabetes Care, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.