CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Tandem t:slim mobile application t:slim Mobile Application, iOS recalled
Tandem Diabetes Care is recalling Tandem t:slim mobile application t:slim Mobile Application, iOS, distributed nationwide in the US. The recall was initiated on 16 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3330-2026
- FDA event ID
- 99589
- Recalling firm
- Tandem Diabetes Care, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jul 2026
- FDA classified
- 29 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 16 Jul 2026 | Recall initiated by company | |
| 29 Sep 2026 | Classified by FDA | +75 days |
| 7 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tandem Diabetes Care
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tandem pumps are battery-operated infusion pumps capable recalled | Tandem Diabetes Care | Device Malfunction | CA |
| Device | CLASS I | Tandem Mobi Insulin Pump: Description recalled by Tandem Diabetes Care | Tandem Diabetes Care | Device Malfunction | 52 states |
| Device | CLASS II | t:slim X2 insulin pump with Interoperable Technology recalled | Tandem Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | t:slim X2 Insulin Pump with Interoperable Technology recalled | Tandem Diabetes Care | Device Malfunction | CA |
| Device | CLASS I | Tandem Mobi Insulin Pump with Interoperable Technology recalled | Tandem Diabetes Care | Labeling Errors | 29 states |
Other Medical Software recalls
All 930| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Ingenia Elition S and Ingenia Elition recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |