FDA Device recall Z-1811-2022
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-1811-2022 |
| 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 | Pump/UDI-DI/Software Versions/Distributor Instructions: t:slim X2 insulin pump/00852162004781, 00852162004798, 00853052…Pump/UDI-DI/Software Versions/Distributor Instructions: t:slim X2 insulin pump/00852162004781, 00852162004798, 00853052007240/ 4.3.5.2, 4.3.6/ For Distributors, All Parts, Contact Recalling Firm to Switch Out; t:slim X2 insulin pump with Dexcom G5/853052007257, 853052007271, 853052007295, 853052007318, 853052007967, 853052007981/ 5.0.1, 5.0.4, 5.3.1.1/ For Distributors, All Parts, Contact Recalling Firm to Switch Out; t:slim X2 insulin pump with Basal-IQ technology/853052007264, 853052007288, 853052007301, 853052007325, 850006613373, 850006613380, 850006613700, 850006613717, 850006613724, 850006613731/ 6.0.4, 6.3.1.1, 6.4/ For Distributors: 1) Parts: 1000886, 1000898, 1004219, 1005706, 1006373 or 1006375, Contact Recalling Firm to Switch Out, 2) Parts: 1010004, 1010005,1010006, No Action Required, Software is Up to Date; t:slim X2 insulin pump with Control-IQ technology/ 850006613229, 850006613205, 850006613212, 850006613762, 850006613779, 850006613786, 850006613793/ 7.3.1.1, 7.4/ For |
|---|
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-1811-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.