Recall Register

Food, drugs, devices › Firms

Tandem Diabetes Care, Inc.

FDA recalling firm · 11 enforcement events · 13 product records · 2014–2026 · CA

Tandem Diabetes Care, Inc. has 11 FDA enforcement events on this register (13 product records) between 2014 and 2026: 11 device; the busiest year was 2025 with 5.

45% of its events are Class I; the most common class is Class II (6). 10 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
30 Jan 2026Tandem 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 insulin infusion pumps on the U.S.…DeviceClass II1Ongoing
6 Oct 2025Tandem 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, into a patient s subcutaneous tissue.…DeviceClass I1Ongoing
5 Aug 2025t: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 User Guide when using Dexcom G7 sensorDeviceClass II1Ongoing
21 Jul 2025Battery 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: 1005611; Pump, t:slim X2, Control-IQ,…DeviceClass I1Ongoing
3 Jul 2025t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)DeviceClass II1Ongoing
27 Feb 2025t:slim X2 Insulin Pump with Interoperable TechnologyDeviceClass I2Ongoing
5 Mar 2024t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technologyDeviceClass I1Ongoing
24 May 2022t: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 TechnologyDeviceClass II2Ongoing
10 Sep 2020t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ TechnologyDeviceClass II1Ongoing
23 Apr 2018t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.DeviceClass II1Ongoing
10 Jan 2014T:slim Insulin Delivery System Insulin Infusion PumpDeviceClass I1Terminated

By type and class

Device11
Class II6
Class I5

Class I: 45% of this firm's events; 18% of all events on the register.

Events by year

14
16
18
20
22
24
26
Enforcement events for Tandem Diabetes Care, Inc. by year initiated.

Questions and answers

How many FDA recalls has Tandem Diabetes Care, Inc. had?

11 enforcement events (13 product records) on this register, 2014–2026: 11 device.

Are any Tandem Diabetes Care, Inc. recalls ongoing?

10 events are listed as ongoing in the current openFDA export.

What class are Tandem Diabetes Care, Inc. recalls?

6 Class II, 5 Class I. 45% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.