FDA Device recall Z-2343-2025
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911
- FDA Device
- Class I
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class I recall of Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911 by Tandem Diabetes Care, citing insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2343-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-07-21 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tandem Diabetes Care |
| Distribution | US |
Product
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198
Reason
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
Identifiers
| code_info | REF/UDI-DI: 1000911/t:slim X2 G5, Replacement, Refurbished/00853052007318; 1003808/t:slim X2 GS Classic, Replacement, R…REF/UDI-DI: 1000911/t:slim X2 G5, Replacement, Refurbished/00853052007318; 1003808/t:slim X2 GS Classic, Replacement, Refurbished/ 00853052007981; 1004219/t: slim X2, Basal-IQ, mg/dl/ 00853052007998; 1004484/Pump, t:slim X2, Clinical Use Only; 1005611/Pump, t:slim X2, Control-IQ, mmoUL/ 00850006613304/; 1005613/Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement/ 00850006613311/; 1005615/Pump, t:slim X2, Control-IQ, mg/dl/ 00850006613328/; 1005617/Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement/ 00850006613335/; 1006379/Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement/ 00850006613731/; 1006402/Pump, t:slim X2, Control-IQ 7.4/ 00850006613762/; 1006406/Pump, t:slim X2, Control-IQ 7.4, Replacement/ 00850006613786/; 1006408/Pump, t:slim X2, Control-IQ 7.4/ 00850006613793/; 1006419/Pump, t:slim X2, Basal-IQ, mmoUL/ 00850006613809/; 1006420/Pump, t:slim X2, Basal-IQ, mg/dL 00850006613816; 1006535/Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement/ 00850006613 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2343-2025%22
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