FDA Medical devices recall ·
Battery Operated infusion pumps recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2343-2025
- Date
- (initiated July 21, 2025)
- Company / brand
- Tandem Diabetes Care, Inc.
12400 High Bluff Dr, San Diego, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 171,750
- Hazard tags
- Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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/ 00850006613823/; 1006537/Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement/ 00850006613830/; 1008255/Pump, t:slim X2, Control-IQ, mg/dl , Replacement/00850018992671; 1008256/Pump, t:slim X2, Control-IQ, mmoUL, Replacement/00850018992664; 1008257/Pump, t:slim X2, Basal-IQ, mmoUL, Replacement/00850018992657; 1008258/Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement/00850018992640; 1010004/Pump, t:slim X2, Basal-IQ/00389152000015; 1010005/Pump, t:slim X2, Basal-IQ, Replacement/00389152000022; 1010006/Pump
Distribution
Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech Republic, Slovakia, Spain, United Kingdom, Belgium, Luxembourg, Australia, France, Italy, New Zealand, Finland, Sweden, Denmark, Norway, Saudi Arabia, Germany, Netherlands, Ireland, Portugal, South Africa, Switzerland
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2343-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.