Class II recallOngoing

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

FDA · FDA event 99589 · FDA posted Sep 29, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

What happened

A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which could lead to users experiencing hypoglycemia or hyperglycemia.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On 07/16/2026, an "URGENT MEDICAL DEVICE CORRECTION" communication was sent via certified mail to customers informing them that an unexpected behavior was identified in the t:slim iOS mobile application version 2.13 made available through TestFlight. The issue involves users unable to pair a compatible FreeStyle Libre 3 Plus sensor after updating to version 2.13. If this occurs, the application will incorrectly display an "Incompatible Sensor" message and prevent sensor use.
Customer are advised to: 1. Discontinue use of iOS t:slim mobile application version 2.13 2. Uninstall version 2.13 from their mobile device. 3. Return to the current production version of the t:slim mobile application (version 2.12.1) available on the Apple App Store. 4. Scan the compatible FreeStyle Libre 3 Plus sensor with version 2.12.1 when starting their next sensor session.
For Questions - contact Tandum Customer Support at 1-877-801-6901 or email Techsupport@tandumdiabetes.com (24/7/365).

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft by Tandem Diabetes Care, Inc..

Products affected by FDA event 99589
Model	Description	Lot / serial range	Manufactured	Status
Z-3330-2026	Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No	Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

Jul 16, 2026
Recall initiated
Date recorded by the FDA.
Sep 29, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 28, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99589
Published: Sep 29, 2026
Source checked: 2026-10-28 03:25:03 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

FDA · FDA event 99589 · FDA posted Sep 29, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

What happened

Affected products and models

This FDA record lists Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft by Tandem Diabetes Care, Inc..

Products affected by FDA event 99589
Model	Description	Lot / serial range	Manufactured	Status
Z-3330-2026	Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No	Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution.

Units affected

See official FDA record

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr recall — FDA event 99818

FDA · FDA event 99818Posted Oct 5, 2026

Class II recallOngoing

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; recall — FDA event 99374

FDA · FDA event 99374Posted Aug 18, 2026

Class II recallOngoing

MiniMed 780G Insulin Pump recall — FDA event 99207

FDA · FDA event 99207Posted Jul 8, 2026

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

Follow Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

Follow Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline