- Recalling firm
- Tandem Diabetes Care, Inc.
- 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.
- Affected products (lot / model / serial)
- Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
- Units affected
- 177
- Distribution pattern
- US Nationwide distribution.
- Firm location
- San Diego, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3330-2026
- Recall initiated
- July 16, 2026
- FDA classification date
- September 29, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99589
- Last updated on HTM Vibe
- October 13, 2026
