PlainRecalls

Tandem Diabetes Care, Inc.

Compiled from official public sources by the publisher.

13 recalls on record · Latest: Apr 1, 2026

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Agency notice ledger

Federal filing book Tandem Diabetes Care, Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,211 of 14,151 · 13 notices · 0.012% archive

  • BOOK 13 notices
  • RANK #1,211 of 14,151
  • SHARE 0.012% archive
  • AGENCY FDA Devices (13)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 1, 2026
  • PHOTO Aequita Pharmacy

Nearest notice-volume peer: Aequita Pharmacy (0 notice gap)

Tandem Diabetes Care, Inc. accounts for about 0.012% of the 104,423-notice archive on 13 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Tandem Diabetes Care, Inc.'s standing among 14,151 recalling firms

Tandem Diabetes Care, Inc. ranks 1,211th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Tandem Diabetes Care, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

13 1211th of 14151 higher than 12,927 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Tandem Diabetes Care, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Tandem Diabetes Care, Inc. holds about 0.012% of archive notices alongside 13 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 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. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
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 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. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi,
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 Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor
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; 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, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump,
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 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 Control-IQ Technology
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

Tandem Diabetes Care, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (13 here — thin-book).

Aequita Pharmacy 13 Alden Optical 13 Amneal Pharmaceuticals, LLC 13 Ani Pharmaceuticals, Inc. 13 AtriCure, Inc. 13

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Aequita Pharmacy 13 Alden Optical 13 AtriCure, Inc. 13 Augustine Temperature Management, LLC 13

Frequently Asked Questions

How many federal recall notices name Tandem Diabetes Care, Inc.? ▼
PlainRecalls indexes 13 distinct federal recall events naming Tandem Diabetes Care, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Tandem Diabetes Care, Inc. sit among other recalling firms? ▼
Tandem Diabetes Care, Inc. ranks #1,211 of 14,151 by distinct recall-event count among 14,151 firms in this archive (91st percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Tandem Diabetes Care, Inc.'s notices? ▼
FDA Devices accounts for 13 of this firm's 13 indexed notices.
What product category dominates Tandem Diabetes Care, Inc.'s filing book? ▼
Filings for Tandem Diabetes Care, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Tandem Diabetes Care, Inc.: 13 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Tandem Diabetes Care, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026