FDA Device recall Z-1812-2022
t:slim X2 insulin pump
- FDA Device
- Class II
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class II recall of t:slim X2 insulin pump by Tandem Diabetes Care, citing insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1812-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-24 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tandem Diabetes Care |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Reason
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.
Identifiers
| code_info | Insulin Pump/Software Versions: t:slim X2 insulin pump/6.4.1 and earlier; t:slim X2 insulin pump with Dexcom G5/5.2.1,…Insulin Pump/Software Versions: t:slim X2 insulin pump/6.4.1 and earlier; t:slim X2 insulin pump with Dexcom G5/5.2.1, 5.2.2; t:slim X2 insulin pump with Basal-IQ technology/6.3.0.1, 6.4, 6.4.1; t: slim x2 insulin pump with the Control-IQ Technology/7.4, 7.4.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1812-2022%22
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