Tandem Diabetes Care recall: T:slim Mobile Application
Tandem Diabetes Care, Inc. is recalling T:slim Mobile Application – 177. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on July 16, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | T:slim Mobile Application |
| Brand | Tandem Diabetes Care |
| Company | Tandem Diabetes Care, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 16, 2026 |
| Published by FDA | October 7, 2026 |
| Quantity | 177 |
| Recall ID | 99589 |
Recalled products
- 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
- FDA recall number
- Z-3330-2026
- Codes, lots and dates
- Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
- Quantity
- 177
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99589
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- San Diego, CA, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99589, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Tandem Diabetes Care T:slim Mobile Application recalled?
Yes. Tandem Diabetes Care, Inc. recalled it on July 16, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.