Quick Facts at a Glance
- Recall Date
- July 3, 2025
- Hazard Level
- HIGH
- Brand
- Tandem Diabetes Care
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Tandem t:slim Mobile App, Android Software Version 2.9.1, t:slim X2 Insulin Pump
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 3, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
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
The t:slim X2 insulin pump with interoperable technology is used by people with diabetes to manage insulin delivery through a paired mobile app.
Why This Is Dangerous
A right-to-left language setting can disrupt app-pump pairing and create display errors, risking incorrect dosing decisions.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The issue could lead to incorrect therapy decisions and potential hypo- or hyperglycemia, requiring clinical follow-up.
Practical Guidance
How to identify if yours is affected
- Verify you have the Tandem t:slim X2 insulin pump and the Tandem t:slim Mobile App.
- Check if your phone uses a right-to-left language setting.
- Confirm the app version is Android Version 2.9.1.
- Look for any pairing or graphical issues with the pump and app.
Where to find product info
Recall notice and device identifiers are provided by Tandem Diabetes Care and the FDA enforcement database.
What timeline to expect
Remediation timelines are not specified; typical recall processes may take several weeks to finalize refunds or replacements.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Contact your healthcare provider for interim guidance.
- Consider filing a consumer safety complaint if the company is unresponsive.
How to prevent similar issues
- Do not modify app settings or language during a pending recall.
- Monitor glucose levels closely if you must continue therapy under clinician instruction.
- Keep app and device software up to date when a confirmed safe version is released by the manufacturer.
Documentation advice
Keep the recall notice, device serial numbers, app version, and all correspondence with the manufacturer for records.
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Product Details
Model numbers: Tandem t:slim Mobile App; Android Software Version 2.9.1; t:slim X2 Insulin Pump. Where sold: International distribution, including Israel. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution: International, including Israel
- Models affected: Tandem t:slim Mobile App; Android Software Version 2.9.1
- Hazard: RTL-language app defect causing pairing issues and display errors
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Safety Guide
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