CLASS I ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
Tandem Mobi Insulin Pump with Interoperable Technology recalled
Tandem Diabetes Care is recalling Tandem Mobi Insulin Pump with Interoperable Technology, distributed in 29 states. The recall was initiated on 27 Feb 2025 and the FDA has classified it as Class I.
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-1520-2025
- FDA event ID
- 96417
- Recalling firm
- Tandem Diabetes Care, San Diego, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 27 Feb 2025
- FDA classified
- 11 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 27 Feb 2025 | Recall initiated by company | |
| 11 Apr 2025 | Classified by FDA | +43 days |
| 23 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Product as listed by the FDA
Tandem Mobi Insulin Pump with Interoperable Technology
Where it was distributed
US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A
ArizonaCaliforniaColoradoConnecticutFloridaHawaiiIowaIdahoIllinoisIndianaMarylandMaineMichiganMissouriMississippiNorth CarolinaNorth DakotaNebraskaNew JerseyNew Mexico
Questions about this recall
Why was it recalled?
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Which lots are affected?
Software versions 7.9/UDI: 00389152480114
Where was it sold?
US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96417This product is part of a recall event; the main page for the event is t:slim X2 Insulin Pump with Interoperable Technology recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | t:slim X2 Insulin Pump with Interoperable Technology recalled | Tandem Diabetes Care | Labeling Errors | 29 states |
More recalls from Tandem Diabetes Care
All 12| 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 | t:slim X2 Insulin Pump with Interoperable Technology recalled | Tandem Diabetes Care | Labeling Errors | 29 states |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |