CLASS II ONGOING Device recall · Reported 22 Jun 2022 · FDA Enforcement Report
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM recalled
Tandem Diabetes Care is recalling t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with. The recall was initiated on 10 Sep 2020 and the FDA has classified it as Class II.
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-1258-2022
- FDA event ID
- 90113
- Recalling firm
- Tandem Diabetes Care, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Sep 2020
- FDA classified
- 10 Jun 2022
- Reported
- 22 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 10 Sep 2020 | Recall initiated by company | |
| 10 Jun 2022 | Classified by FDA | +638 days |
| 22 Jun 2022 | 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
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Where it was distributed
International distribution in the country of Australia.
Questions about this recall
Why was it recalled?
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
Which lots are affected?
Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier
Where was it sold?
International distribution in the country of Australia.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Tandem Diabetes Care
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tandem t:slim mobile application t:slim Mobile Application, iOS recalled | Tandem Diabetes Care | Device Malfunction | Nationwide |
| 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 |
Other Insulin Pumps & Glucose Monitors recalls
All 468| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The MiniMed Go app for iOS or MiniMed Go app recalled | Medtronic MiniMed | Device Malfunction | Nationwide |
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |