Quick Facts at a Glance
- Recall Date
- August 5, 2025
- Hazard Level
- HIGH
- Brand
- Tandem Diabetes Care
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Tandem Diabetes Care
- Product type
- Insulin Pump
- Model numbers
- t:slim X2, Tandem Mobi
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 5, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tandem Diabetes Care, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Insulin pumps like the t:slim X2 and Tandem Mobi are CGM-integrated devices used to deliver insulin with automated features. They are widely used by adults with diabetes to manage glucose levels.
Why This Is Dangerous
A software defect can cause an unexpected automatic insulin correction bolus, potentially driving insulin too high or too low and risking hypoglycemia.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The defect could lead to unexpected hypoglycemia, which can be dangerous if not promptly addressed. Users may need to switch to alternative insulin delivery methods during remediation.
Practical Guidance
How to identify if yours is affected
- 1. Check device model: t:slim X2 or Tandem Mobi.
- 2. Verify software version: 7.9.0.1 or 7.10.1 for X2; 7.9.0.1 for Mobi.
- 3. Confirm Dexcom G7 pairing.
Where to find product info
Recall letter and manufacturer guidance. The FDA enforcement page provides official details.
What timeline to expect
Typically 4-8 weeks for refunds or replacements after submission of a claim.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to FDA recall processes if the company delays resolution.
- Consult your healthcare provider for interim management options.
How to prevent similar issues
- Keep software updated when updates are released by manufacturers.
- Periodically verify sensor-device pairings.
- Follow all recall communications and avoid relying on corrective boluses from recalled firmware.
Documentation advice
Keep the recall notice, device serial numbers, software versions, dates of purchase, and all correspondence with the manufacturer.
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Product Details
Brand: Tandem Diabetes Care Products: t:slim X2 insulin pump with Interoperable Technology and Control-IQ+ technology; Tandem Mobi insulin pump with Interoperable Technology and Control-IQ+ technology REF numbers: 1014070, 1014071, 1014072, 1014073 (t:slim X2); 1014801, 1014811, 1014813 (Tandem Mobi) Software versions: t:slim X2 7.9.0.1 and 7.10.1; Mobi 7.9.0.1 UDI-DI: 00389152407012, 00389152407111, 00389152407210, 00389152407319 (t:slim X2); 00389152480114, 00389152481111, 00389152481319 (Mobi) User Guide: AW-1014562 Revision D; AW-1014938 Revision C Distribution: US nationwide includingPR N
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Software versions 7.9.0.1 and 7.10.1 (t:slim X2) and 7.9.0.1 (Mobi)
- Dexcom G7 sensor pairing involved
- Distribution: US nationwide including Puerto Rico
- Recall status: Active
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Safety Guide
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