Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Why it was recalled
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Tandem t:slim Mobile App, Android Software Version 2.9.1 UDI-DI code: 00389152470641 Serial Numbers / Cell Phone OS: 1163923 Google Pixel 8 Pro husky [15 35] 1164430 samsung SM-S901E r0qxxx [15 35] 1167131 samsung SM-A346E a34xdxx [14 34] 1299238 samsung SM-G780G r8qxx [13 33] 1300180 samsung SM-S928B e3qxxx [15 35] 1300180 samsung SM-S928B e3qxxx [14 34] 1329242 Google Pixel 6 Pro raven [15 35] 1381313 samsung SM-G780G r8qxx [13 33] 1381315 Google Pixel 9 tokay [16 36] 1381537 samsung SM-A546E a54xnsxx [14 34] 1381570 Xiaomi 2407FPN8EG rothko_global [15 35] 1391808 samsung SM-S711B r11sxxx [14 34] 1391892 samsung SM-N980F c1sxx [13 33] 1392863 samsung SM-S926B e2sxxx [15 35] 1392953 samsung SM-S916B dm2qxxx [15 35] 1393040 samsung SM-S901E r0qxxx [15 35] 90615975 realme RMX3241 RMX3241 [13 33] 90754587 samsung SM-S916B dm2qxxx [15 35] 901144584 samsung SM-S901E r0qxxx [14 34]
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
International distribution to the country of Israel.
Recall record
- Recalling firm
- Tandem Diabetes Care, Inc.
- Product type
- Devices
- Recall number
- Z-2621-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- San Diego, CA
- Recall initiated
- 2025-07-03
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2621-2025 · Source: openFDA enforcement.