Reported Sep 3, 2025 · Ongoing
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic,…
Tandem Diabetes Care, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care, Inc. · 12400 High Bluff Dr · San Diego, CA · 92130-3077
Is this the product you have?
35 products · 130 lot codes
1000911Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished
3 recalled lot codes
t:slim X2 G5ReplacementRefurbished/00853052007318
1003808t:slim X2 GS Classic, Replacement, Refurbished
3 recalled lot codes
t:slim X2 GS ClassicReplacementRefurbished/ 00853052007981
1004219t: slim X2, Basal-IQ, mg/dl
3 recalled lot codes
t: slim X2Basal-IQmg/dl/ 00853052007998
1004484Pump, t:slim X2, Clinical Use Only
3 recalled lot codes
Pumpt:slim X2Clinical Use Only
Page 1 of 9
- Amount recalled
- 171,750
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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