PlainRecalls

Tandem Diabetes Care Inc

Compiled from official public sources by the editorial team.

13 recalls on record · Latest: Apr 1, 2026

Tandem Diabetes Care Inc Recall Insight

Tandem Diabetes Care Inc appears on 13 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.013% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 1, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 13 entries, severity tagging shows 6 critical, 7 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 13 of 13 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (13). The date window on this page runs from Feb 19, 2014 to Apr 1, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 1, 2026

Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to d…

FDA Devices Critical Nov 12, 2025

Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of …

FDA Devices Moderate Oct 29, 2025

t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexc…

FDA Devices Moderate Oct 1, 2025

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

FDA Devices Critical Sep 3, 2025

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;…

FDA Devices Critical Apr 23, 2025

t:slim X2 Insulin Pump with Interoperable Technology

FDA Devices Critical Apr 23, 2025

Tandem Mobi Insulin Pump with Interoperable Technology

FDA Devices Critical May 15, 2024

t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

FDA Devices Moderate Oct 5, 2022

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 Cont…

FDA Devices Moderate Oct 5, 2022

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 Cont…

FDA Devices Moderate Jun 22, 2022

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

FDA Devices Moderate Jul 25, 2018

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.

FDA Devices Critical Feb 19, 2014

T:slim Insulin Delivery System Insulin Infusion Pump

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Tandem Diabetes Care Inc with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.