Class II U.S. Food and Drug Administration

Tandem Diabetes Care t:slim X2 insulin pumps recall: Potential speaker-related issue that can trigger an error resulting

Recall published 1+ years ago

Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0232-2026
Published
August 7, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Tandem Diabetes Care
Product type
Medical devices
Units affected
122,958
Distribution
Nationwide
Lot / code info
t:slim X2, UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 with software versions 7.9.0.1 and 7.10.1, User Guide versions not including and prior to: AW-1014562 Revision D; Tandem Mobi, UDI-DI: 00389152480114, 00389152481111, 00389152481319 with software version 7.9.0.1, User Guide versions not including and prior to: AW-1014938 Revision C
UPC codes
00389152407012, 00389152407111, 00389152407210, 00389152407319, 00389152480114, 00389152481111, 00389152481319

Products covered by this recall

t:slim X2 insulin pumps

What the company announced

SAN DIEGO – August 7, 2025 – Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery.

The error, which appears as a Malfunction 16 alarm to the user, will stop insulin delivery and terminate communication between the insulin pump and the continuous glucose monitoring (CGM) device. If not addressed, this could result in hyperglycemia due to discontinuation of insulin delivery, real-time CGM Estimated Glucose Values, and CGM trends. In severe cases of hyperglycemia, the user may require hospitalization or intervention from a medical professional. There have been 700 confirmed adverse events, defined as a confirmed high blood sugar and/or an event requiring medical intervention, and 59 reported injuries. No deaths have been reported.

Notices were sent directly to impacted customers in the United States (U.S.) between July 22 and 24, 2025 with instructions on what to do in the event of a Malfunction 16. A copy of this customer notification can be found at https://www.tandemdiabetes.com/docs/default-source/legal/companyupdate/malfunction-16-speaker-issue-tslimx2-qsf0024231.pdf .

More information, including a searchable list of serial numbers for impacted pumps can be found at tandemdiabetes.com/mal16-2025 . The U.S. Food and Drug Administration and regulatory agencies outside of the U.S. have been notified of this action.

Tandem will be releasing a software update designed to enhance early detection of speaker failure. This update will also introduce persistent vibration alerts to help reduce potential safety risk. Tandem will notify all pump users when the software update becomes available and to request pump users complete the update of their insulin pump.

Impacted customers in the U.S. with questions about this recall can contact the Tandem Diabetes Care Technical Support Team 24 hours a day, 7 days a week at [email protected] or (877) 801-6901. International customers should reach out to their local distributor for more information. Contact information for each country can be found at tandemdiabetes.com.

Forward Looking Statement

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things, the Company’s plan to enhance detection of a speaker failure with this software update, the timing of this software update, and the ability to reach all of our impacted customers about this software update. These statements are subject to numerous risks and uncertainties, including our ability to enhance detection of a speaker failure, the possibility that the rollout of the software update will be delayed and the possibility that not every impacted customer will update their software app to this version as well as other risks and uncertainties identified in the Company’s most recent Annual report on Form 10-K and its other filings with the Securities and Exchange Commissions. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.

Important Safety Information

RX ONLY. The t:slim X2 pump with interoperable technology (the pump) and Control-IQ+ technology (Control-IQ+) are intended for single patient use. The pump and Control-IQ+ are indicated for use with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons 2 years of age and greater. Control-IQ+ technology: Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.

WARNING: Control-IQ+ should not be used in anyone under the age of 2 years old with Type 1 diabetes or under the age of 18 years old with Type 2 diabetes. It should also not be used in patients who require less than a total daily insulin dose of 5 units of insulin per day or who weigh less than 20 pounds (9 kilograms), as those are the required minimum values needed for Control-IQ+ to operate safely.

Users of the pump and Control-IQ+ must: use the insulin pump, iCGM, and all other system components in accordance with their respective instructions for use. Failure to follow these instructions for use could result in an over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

Media Contact : 858-366-6900

[email protected]

Investor Contact : 858-366-6900

[email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00389152407012
  • 00389152407111
  • 00389152407210
  • 00389152407319
  • 00389152480114
  • 00389152481111
  • 00389152481319

Model or item number

On the rating label, the box or the instruction sheet.

  • 1014070
  • 1014071
  • 1014072
  • 1014073
  • 1014801
  • 1014811
  • 1014813

Package size

Match the net weight or the piece count on the front of the pack.

  • 20 pounds

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Tandem Diabetes Care — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Remedy named in the notice: This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements.

Company contact: Tandem Diabetes Care, Inc. — Consumers: Tandem Diabetes Care Technical Support Team, (877) 801-6901, [email protected] — Media: 858-366-6900, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Tandem Diabetes Care medical devices recalled?

Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00389152407012, 00389152407111, 00389152407210; model number 1014070, 1014071, 1014072. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements.

Where was the recalled product sold?

It was distributed nationwide.

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