Manufacturer

Tandem Diabetes Care, Inc.

13 recalls in our database name Tandem Diabetes Care, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 13
Critical: 2
Severe: 4
Most recent: 2026-04-01

Of the 13 recalls from Tandem Diabetes Care, Inc. we have scored against our rubric, 2 (15%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (31%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

HighFDA (Devices)·Z-1636-2026·2026-04-01
Tandem insulin pump Czech guide inverted a key connection instruction
Tandem Diabetes Care is recalling insulin pumps distributed in the Czech Republic and Slovakia because the Czech user guide contains translation errors, including one that inverts an infusion set instruction.
Product
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current i
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0427-2026·2025-11-12
Insulin pumps recalled over false vibration motor failure stopping delivery
Tandem Diabetes Care is recalling 17,745 Tandem Mobi insulin pumps because a software issue can trigger a false vibration motor failure that halts insulin delivery. The FDA classified it Class I.
Product
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set,
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-0232-2026·2025-10-29
Insulin pumps recalled over software defect causing unexpected correction bolus
Tandem Diabetes Care is recalling 122,958 t:slim X2 and Mobi insulin pumps because a software defect when paired with a Dexcom G7 sensor may trigger an unexpected automatic correction bolus.
Product
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2621-2025·2025-10-01
Insulin pump app recalled over defect in right-to-left language settings
The t:slim X2 Insulin Pump with the Tandem t:slim mobile app is recalled because an app defect in right-to-left language settings causes pairing and graphical faults that could lead to incorrect therapy decisions.
Product
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2343-2025·2025-09-03
Insulin pumps recalled over malfunction that stops insulin delivery and alerts
Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.
Product
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1519-2025·2025-04-23
t:slim X2 Insulin Pump Software Defect Affecting Glucose Delivery
Tandem Diabetes Care is recalling 63 units of the t:slim X2 Insulin Pump with software version 7.9 due to a defect that can cause incorrect insulin delivery. The defect may lead to dangerous blood sugar levels when glucose monitoring loses connection.
Product
t:slim X2 Insulin Pump with Interoperable Technology
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1520-2025·2025-04-23
Tandem Mobi Insulin Pump Software Defect Risks Incorrect Insulin Delivery
Tandem Diabetes Care is recalling Tandem Mobi Insulin Pumps with software version 7.9 due to a defect that can cause incorrect insulin delivery when glucose data gaps occur, potentially leading to severe high or low blood sugar.
Product
Tandem Mobi Insulin Pump with Interoperable Technology
Category
Medical Device
Distribution
29 states
SevereFDA (Devices)·Z-1609-2024·2024-05-15
Insulin pump app may crash and drain battery, risking insulin delivery interruption
Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.
Product
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1812-2022·2022-10-05
t:slim X2 Insulin Pumps Recalled for Software Issues Affecting Blood Sugar Management
Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve the issues.
Product
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1811-2022·2022-10-05
Insulin pumps recalled for software malfunctions affecting blood glucose control
Tandem Diabetes Care is recalling 31,100 t:slim X2 insulin pumps due to software issues that could cause inaccurate insulin delivery, potentially leading to dangerous blood sugar levels. A software update is available to address the issues.
Product
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1258-2022·2022-06-22
Tandem t:slim X2 Insulin Pump Battery Display May Cause Insulin Delivery Failure
Tandem t:slim X2 insulin pumps may display inaccurate battery levels, risking insulin delivery failure if the battery depletes unexpectedly. Users should maintain battery above 25% to prevent unintended insulin cessation.
Product
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2471-2018·2018-07-25
Tandem t:slim G4 Insulin Pump Recalled for Inaccurate Battery Readings
Tandem Diabetes Care is recalling 55 t:slim G4 Insulin Pumps because the fuel gauge may provide inaccurate battery readings, causing the pump to stop delivering insulin.
Product
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.
Category
Medical Device
Distribution
23 states
SevereFDA (Devices)·Z-0827-2014·2014-02-19
Tandem T:slim Insulin Pump Cartridges Recalled for Leak Risk
Tandem Diabetes Care is recalling specific lots of T:slim insulin cartridges due to a risk of leaking, which could cause incorrect insulin delivery.
Product
T:slim Insulin Delivery System Insulin Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Tandem Diabetes Care, Inc.

U.S. healthcare company

Country: United States
Founded: 2008

Official website

Source: Wikidata (Q22121872), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.