Battery Operated infusion pumps — Class I medical device recall Z-2343-2025
Ongoing recall by Tandem Diabetes Care, Inc., reported 2025-09-03, distributed nationwide. Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which preven
| Recall number | Z-2343-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care, Inc., San Diego, CA, United States |
| Recall initiated | 2025-07-21 |
| Classified | 2025-08-27 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IT, LU, NL, NO, NZ, PT, SA, SE, SK, ZA |
| Quantity | 171,750 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00389152000015, 00389152000022, 00389152000039, 00389152000046, 00389152000077, 00389152000084, 00389152000091, 00389152000107, 00389152286716, 00389152286815, 00389152286914, 00389152319513, 00389152319612, 00389152319711, 00389152319810, 00850006613304, 00850006613311, 00850006613328, 00850006613335, 00850006613731, 00850006613762, 00850006613786, 00850006613793, 00850006613809, 00850006613816 and 9 more |
| Serial numbers | 1007779, 1007780, 1007796, 1007799, 1007800, 1007805, 1008467, 1008486, 1008487, 1008514, 1008531, 1008575, 1008590, 1008615, 1008694, 1008760, 1008806, 1008820, 1008828, 1008904, 1008939, 1009063, 1009123, 1009191, 1009214 and 475 more |
| Model numbers | 1000911, 1003808, 1004219, 1004484, 1005611, 1005613, 1005615, 1005617, 1006379, 1006402, 1006406, 1006408, 1006419, 1006420, 1006535, 1006537, 1008255, 1008256, 1008257, 1008258, 1010004, 1010005, 1010006, 1010007, 1010009 and 11 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2343-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.