Tandem Diabetes Care, Inc.: Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.

Agency Publication Date: August 27, 2025

Summary

Tandem Diabetes Care, Inc. is recalling approximately 171,750 t:slim X2 insulin pumps across several models, including G5, Basal-IQ, and Control-IQ versions. These pumps may have been manufactured with defective internal speakers that can cause a 'Malfunction 16' error, making the pump inoperable and preventing audible alerts. If the pump stops delivering insulin without warning, the user could experience dangerously high blood sugar (hyperglycemia) which can lead to serious injury or hospitalization. These battery-operated pumps are used for the delivery of insulin in people with diabetes.

Risk

The internal speaker may fail, triggering a malfunction that completely stops insulin delivery and silences all alarms. This poses a critical risk of severe hyperglycemia or diabetic ketoacidosis because the user will not receive necessary insulin or the audible alerts intended to warn them of the pump's failure.

What You Should Do

Check your insulin pump to see if it is a Tandem t:slim X2 model (including G5, GS Classic, Basal-IQ, or Control-IQ) by looking at the label on the back of the device for the REF number and serial number.
Verify if your specific REF number (such as 1000911, 1004219, 1005611, or 1013195) and Serial Number match the extensive list of affected units provided in the recall notice.
If your pump experiences a 'Malfunction 16' error, it will stop all insulin delivery; immediately switch to your backup insulin plan as previously discussed with your doctor.
Contact your healthcare provider immediately if you experience symptoms of high blood sugar or have questions about your insulin therapy while using this device.
Contact Tandem Diabetes Care, Inc. for further instructions regarding a potential replacement or technical support at their official website or customer support line.
For additional questions or to report a problem, contact the FDA Medical Device hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer support and medical consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: t:slim X2 G5, Replacement, Refurbished

Model / REF:

1000911

UPC Codes:

00853052007318

Product: t:slim X2 GS Classic, Replacement, Refurbished

Model / REF:

1003808

UPC Codes:

00853052007981

Product: t:slim X2, Basal-IQ, mg/dl

Model / REF:

1004219

UPC Codes:

00853052007998

Product: Pump, t:slim X2, Clinical Use Only

Model / REF:

1004484

Product: Pump, t:slim X2, Control-IQ, mmoUL

Model / REF:

1005611

UPC Codes:

00850006613304

Product: Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement

Model / REF:

1005613

UPC Codes:

00850006613311

Product: Pump, t:slim X2, Control-IQ, mg/dl

Model / REF:

1005615

UPC Codes:

00850006613328

Product: Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement

Model / REF:

1005617

UPC Codes:

00850006613335

Product: Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement

Model / REF:

1006379

UPC Codes:

00850006613731

Product: Pump, t:slim X2, Control-IQ 7.4

Model / REF:

1006402

UPC Codes:

00850006613762

Product: Pump, t:slim X2, Control-IQ 7.4, Replacement

Model / REF:

1006406

UPC Codes:

00850006613786

Product: Pump, t:slim X2, Control-IQ 7.4

Model / REF:

1006408

UPC Codes:

00850006613793

Product: Pump, t:slim X2, Basal-IQ, mmoUL

Model / REF:

1006419

UPC Codes:

00850006613809

Product: Pump, t:slim X2, Basal-IQ, mg/dL

Model / REF:

1006420

UPC Codes:

00850006613816

Product: Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement

Model / REF:

1006535

UPC Codes:

00850006613823

Product: Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement

Model / REF:

1006537

UPC Codes:

00850006613830

Product: Pump, t:slim X2, Control-IQ, mg/dl, Replacement

Model / REF:

1008255

UPC Codes:

00850018992671

Product: Pump, t:slim X2, Control-IQ, mmoUL, Replacement

Model / REF:

1008256

UPC Codes:

00850018992664

Product: Pump, t:slim X2, Basal-IQ, mmoUL, Replacement

Model / REF:

1008257

UPC Codes:

00850018992657

Product: Pump, t:slim X2, Basal-IQ, mg/dl, Replacement

Model / REF:

1008258

UPC Codes:

00850018992640

Product: Pump, t:slim X2, Basal-IQ

Model / REF:

1010004

UPC Codes:

00389152000015

Product: Pump, t:slim X2, Basal-IQ, Replacement

Model / REF:

1010005

UPC Codes:

00389152000022

Product: Pump, t:slim X2, Basal-IQ, Medicare

Model / REF:

1010006

1010007

UPC Codes:

00389152000039

00389152000046

Product: Pump, t:slim X2, Control-IQ

Model / REF:

1010009

1012867

UPC Codes:

00389152000077

00389152286716

Product: Pump, t:slim X2, Control-IQ Replacement

Model / REF:

1010010

UPC Codes:

00389152000084

Product: Pump, t:slim X2, Control-IQ, Medicare

Model / REF:

1010011

1012868

UPC Codes:

00389152000091

00389152286815

Product: Pump, t:slim X2, Control-IQ, Refurbished Replacement

Model / REF:

1010012

UPC Codes:

00389152000107

Product: Pump, t:slim X2, Control-IQ, Replacement

Model / REF:

1012869

UPC Codes:

00389152286914

Product: Pump, t:slim X2, Control-IQ 7.8

Model / REF:

1013195

UPC Codes:

00389152319513

Product: Pump, t:slim X2, Control-IQ 7.8, Medicare

Model / REF:

1013196

UPC Codes:

00389152319612

Product: Pump, t:slim X2, Control-IQ 7.8, Replacement

Model / REF:

1013197

UPC Codes:

00389152319711

Product: Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement

Model / REF:

1013198

UPC Codes:

00389152319810

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97003

Status: Active

Manufacturer: Tandem Diabetes Care, Inc.

Manufactured In: United States

Units Affected: 171,750

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your insulin pump to see if it is a Tandem t:slim X2 model (including G5, GS Classic, Basal-IQ, or Control-IQ) by looking at the label on the back of the device for the REF number and serial number.

Verify if your specific REF number (such as 1000911, 1004219, 1005611, or 1013195) and Serial Number match the extensive list of affected units provided in the recall notice.

If your pump experiences a 'Malfunction 16' error, it will stop all insulin delivery; immediately switch to your backup insulin plan as previously discussed with your doctor.

Contact your healthcare provider immediately if you experience symptoms of high blood sugar or have questions about your insulin therapy while using this device.

Contact Tandem Diabetes Care, Inc. for further instructions regarding a potential replacement or technical support at their official website or customer support line.

For additional questions or to report a problem, contact the FDA Medical Device hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: t:slim X2 G5, Replacement, Refurbished

Model / REF:

1000911

UPC Codes:

00853052007318

Product: t:slim X2 GS Classic, Replacement, Refurbished

Model / REF:

1003808

UPC Codes:

00853052007981

Product: t:slim X2, Basal-IQ, mg/dl

Model / REF:

1004219

UPC Codes:

00853052007998

Product: Pump, t:slim X2, Clinical Use Only

Model / REF:

1004484

Product: Pump, t:slim X2, Control-IQ, mmoUL

Model / REF:

1005611

UPC Codes:

00850006613304

Product: Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement

Model / REF:

1005613

UPC Codes:

00850006613311

Product: Pump, t:slim X2, Control-IQ, mg/dl

Model / REF:

1005615

UPC Codes:

00850006613328

Product: Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement

Model / REF:

1005617

UPC Codes:

00850006613335

Product: Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement

Model / REF:

1006379

UPC Codes:

00850006613731

Product: Pump, t:slim X2, Control-IQ 7.4

Model / REF:

1006402

UPC Codes:

00850006613762

Product: Pump, t:slim X2, Control-IQ 7.4, Replacement

Model / REF:

1006406

UPC Codes:

00850006613786

Product: Pump, t:slim X2, Control-IQ 7.4

Model / REF:

1006408

UPC Codes:

00850006613793

Product: Pump, t:slim X2, Basal-IQ, mmoUL

Model / REF:

1006419

UPC Codes:

00850006613809

Product: Pump, t:slim X2, Basal-IQ, mg/dL

Model / REF:

1006420

UPC Codes:

00850006613816

Product: Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement

Model / REF:

1006535

UPC Codes:

00850006613823

Product: Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement

Model / REF:

1006537

UPC Codes:

00850006613830

Product: Pump, t:slim X2, Control-IQ, mg/dl, Replacement

Model / REF:

1008255

UPC Codes:

00850018992671

Product: Pump, t:slim X2, Control-IQ, mmoUL, Replacement

Model / REF:

1008256

UPC Codes:

00850018992664

Product: Pump, t:slim X2, Basal-IQ, mmoUL, Replacement

Model / REF:

1008257

UPC Codes:

00850018992657

Product: Pump, t:slim X2, Basal-IQ, mg/dl, Replacement

Model / REF:

1008258

UPC Codes:

00850018992640

Product: Pump, t:slim X2, Basal-IQ

Model / REF:

1010004

UPC Codes:

00389152000015

Product: Pump, t:slim X2, Basal-IQ, Replacement

Model / REF:

1010005

UPC Codes:

00389152000022

Product: Pump, t:slim X2, Basal-IQ, Medicare

Model / REF:

1010006

1010007

UPC Codes:

00389152000039

00389152000046

Product: Pump, t:slim X2, Control-IQ

Model / REF:

1010009

1012867

UPC Codes:

00389152000077

00389152286716

Product: Pump, t:slim X2, Control-IQ Replacement

Model / REF:

1010010

UPC Codes:

00389152000084

Product: Pump, t:slim X2, Control-IQ, Medicare

Model / REF:

1010011

1012868

UPC Codes:

00389152000091

00389152286815

Product: Pump, t:slim X2, Control-IQ, Refurbished Replacement

Model / REF:

1010012

UPC Codes:

00389152000107

Product: Pump, t:slim X2, Control-IQ, Replacement

Model / REF:

1012869

UPC Codes:

00389152286914

Product: Pump, t:slim X2, Control-IQ 7.8

Model / REF:

1013195

UPC Codes:

00389152319513

Product: Pump, t:slim X2, Control-IQ 7.8, Medicare

Model / REF:

1013196

UPC Codes:

00389152319612

Product: Pump, t:slim X2, Control-IQ 7.8, Replacement

Model / REF:

1013197

UPC Codes:

00389152319711

Product: Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement

Model / REF:

1013198

UPC Codes:

00389152319810