Recall archive / FDA device enforcement

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacem... — FDA record Z-2343-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 21, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification: Class I
Recalling firm: Tandem Diabetes Care, Inc.
Quantity: 171,750
Agency-reported status: Ongoing
Source record identifier: Z-2343-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, t:slim X2, Basal-IQ, Medicare/00389152000039; 1010007/Pump, t:slim X2, Basal-IQ, Medicare/00389152000046; 1010009/Pump, t:slim X2, Control-IQ/00389152000077; 1010010/Pump, t:slim X2, Control-IQ Replacement/00389152000084; 1010011/Pump, t:slim X2, Control-IQ, Medicare/00389152000091; 1010012/Pump, t:slim X2, Control-IQ, Refurbished Replacement/00389152000107; 1012867/Pump, t:slim X2, Control-IQ/00389152286716; 1012868/Pump, t:slim X2, Control-IQ, Medicare/00389152286815; 1012869/Pump, t:slim X2, Control-IQ, Replacement/00389152286914; 1013195/Pump, t:slim X2, Control-IQ 7.8/00389152319513; 1013196/Pump, t:slim X2, Control-IQ 7.8, Medicare/00389152319612; 1013197/Pump, t :slim X2, Control-IQ 7.8, Replacement/00389152319711; 1013198/Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement/00389152319810 Serial Numbers: 951824 1009214 1009818 1010205 1010216 1010280 1010282 1124339 1124359 1120792 1284185 1096196 1011443 1127741 1017739 1088141 1023688 1084425 1028167 1028228 1033168 1109355 1035333 1044731 1037937 1038725 1040458 1040729 1044512 1041052 1041217 1041397 1041457 1156947 1043829 1044400 1044800 1284661 1049585 1049643 1053348 1186711 1191406 1121799 1132861 1124364 1123627 1063736 1064271 1064593 1106444 1067539 1067828 1067887 1172701 1174318 1098764 1110835 1073710 1128723 1124356 1121152 1127745 1076858 1085036 1101544 1088173 1113296 1109496 1132398 1099207 1134096 1109488 1188241 1188233 1187866 1174100 1177299 1186285 1085203 1086053 1169060 1098778 1099063 1098525 1132410 1134897 1139347 1149413 1149109 1109118 1147667 1149987 1193922 1095865 1148061 1120208 1125365 1127634 1127974 1139150 1138109 1098244 1149017 1099022 1115201 1115510 1101725 1195419 1160890 1195424 1190520 1195271 1190631 1193090 1188686 1151553 1196393 1157533 1011994 1011686 1010370 1010330 1010149 1010339 1009580 1010186 1018441 1018522 1020329 1020438 1020404 1021017 1020215 1018419 1018458 1020226 1018560 1016948 1020578 1020553 1020572 1020531 1020263 1020113 1020100 1020054 1020712 1020104 1020560 1020655 1020487 1023365 1022648 1021118 1020917 1020373 1024186 1023401 1023533 1024261 1023478 1022834 1022835 1022828 1024374 1024315 1024201 1024386 1010323 1008806 1008828 1009705 1009241 1009735 1009666 1009722 1008939 1009686 1009704 1009284 1009191 1009123 1010025 1010059 1010067 1010279 1009063 1008575 1010022 1010277 1010338 1010221 1010107 1010315 1010211 1008487 1008531 1008486 1008514 1008467 1008820 1008760 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1124645 1171630 1128058 1192760 1199256 1041436 1028194 1046514 1051446 1186366 1068685 1069098 1190306 1134047 1134171 1139177 1178806 1077251 1186704 1187882 1153484 1192833 1097968 1174185 1177302 1078805 1062474 1188444 1068442 1017620 1133966 1134168 1133923 1045006 1049986 1027826 1027863 1028082 1115043 1188065 1195410 1132412 1190810 1060916 1064324 1127690 1189618 1192014 1050166 1148219 1149181 1088207 1087517 1190690 1055413 1049148 1194945 1113841 1097944 1098373 1094776 1100542 1098741 1078809 1104411 1102879 1153115 1134330 1119451 1177308 1139370 1137433 1134230 1138902 1127530 1115352 1126191 1088668 1070852 1071114 1150805 1028093 1142869 1115573 1060251 1119165 1148103 1148252 1155202 1037868 1044505 1041767 1037657 1044876 1040916 1040005 1064578 1068543 1190656 1191920 1190333 1189995 1107638 1132985 1127796 1161655 1119431 1164693 1157998 1127399 1090061 1034401 1199272 1169560 1064463 1090307 1085098 1119291 1117988 1038235 1042748 1034171 1145625 1125416 1090125 1085931 1085838 1060204 1189925 1161359 1169009 1094360 1186439 1186538 1147450 1098342 1104538 1095317 1105508 1149079 1041092 1041533 1041486 1044501 1040775 1160502 1195540 1192977 1067804 1151347 1072222 1158592 1133254 1121023 1088225 1040013 1099204 1130727 1089982 1188481 1050238 1109317 1117711 1113350 1044344 1040749 1135367 1063760 1121177 1059012 1059471 1182547 1184806 1079229 1115470 1030849 1186423 1116132 1008590 1098717 1083132 1192291 1114635 1177305 1124112 1134200 1138825 1056228 1195432 1125559 1125290 1097926 1125556 1062527 1072412 1103856 1086051 1085025 1077553 1139569 1098152 1096490 1099195 1131060 1138074 1136777 1139306 1118953 1148637 1148729 1064590 1064916 1127185 1044690 1044467 1151356 1171599 1044350 1160551 1116465 1166998 1150231 1189954 1061548 1061146 1149390 1161522 1157905 1063919 1064079 1060630 1059475 1114013 1071463 1153225 1114841 1071453 1044962 1049380 1041727 1177290 1060246 1060236 1186683 1190579 1128697 1032549 1068036 1085123 1028225 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1128712 1102876 1099561 1049620 1109410 1134...

Label field

Details supplied by the agency

Lot, code or applicability

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, t:slim X2, Basal-IQ, Medicare/00389152000039; 1010007/Pump, t:slim X2, Basal-IQ, Medicare/00389152000046; 1010009/Pump, t:slim X2, Control-IQ/00389152000077; 1010010/Pump, t:slim X2, Control-IQ Replacement/00389152000084; 1010011/Pump, t:slim X2, Control-IQ, Medicare/00389152000091; 1010012/Pump, t:slim X2, Control-IQ, Refurbished Replacement/00389152000107; 1012867/Pump, t:slim X2, Control-IQ/00389152286716; 1012868/Pump, t:slim X2, Control-IQ, Medicare/00389152286815; 1012869/Pump, t:slim X2, Control-IQ, Replacement/00389152286914; 1013195/Pump, t:slim X2, Control-IQ 7.8/00389152319513; 1013196/Pump, t:slim X2, Control-IQ 7.8, Medicare/00389152319612; 1013197/Pump, t :slim X2, Control-IQ 7.8, Replacement/00389152319711; 1013198/Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement/00389152319810 Serial Numbers: 951824 1009214 1009818 1010205 1010216 1010280 1010282 1124339 1124359 1120792 1284185 1096196 1011443 1127741 1017739 1088141 1023688 1084425 1028167 1028228 1033168 1109355 1035333 1044731 1037937 1038725 1040458 1040729 1044512 1041052 1041217 1041397 1041457 1156947 1043829 1044400 1044800 1284661 1049585 1049643 1053348 1186711 1191406 1121799 1132861 1124364 1123627 1063736 1064271 1064593 1106444 1067539 1067828 1067887 1172701 1174318 1098764 1110835 1073710 1128723 1124356 1121152 1127745 1076858 1085036 1101544 1088173 1113296 1109496 1132398 1099207 1134096 1109488 1188241 1188233 1187866 1174100 1177299 1186285 1085203 1086053 1169060 1098778 1099063 1098525 1132410 1134897 1139347 1149413 1149109 1109118 1147667 1149987 1193922 1095865 1148061 1120208 1125365 1127634 1127974 1139150 1138109 1098244 1149017 1099022 1115201 1115510 1101725 1195419 1160890 1195424 1190520 1195271 1190631 1193090 1188686 1151553 1196393 1157533 1011994 1011686 1010370 1010330 1010149 1010339 1009580 1010186 1018441 1018522 1020329 1020438 1020404 1021017 1020215 1018419 1018458 1020226 1018560 1016948 1020578 1020553 1020572 1020531 1020263 1020113 1020100 1020054 1020712 1020104 1020560 1020655 1020487 1023365 1022648 1021118 1020917 1020373 1024186 1023401 1023533 1024261 1023478 1022834 1022835 1022828 1024374 1024315 1024201 1024386 1010323 1008806 1008828 1009705 1009241 1009735 1009666 1009722 1008939 1009686 1009704 1009284 1009191 1009123 1010025 1010059 1010067 1010279 1009063 1008575 1010022 1010277 1010338 1010221 1010107 1010315 1010211 1008487 1008531 1008486 1008514 1008467 1008820 1008760 1008615 1008904 1008694 1021317 1011702 1019671 1021237 1021192 1021279 1021324 1021318 1010379 1021299 1021301 1010249 1019683 1011761 1021325 1021261 1019418 1021284 1010359 1010356 1064999 1044969 1044176 1191892 1191939 1152446 1195279 1185661 1134013 1072356 1125364 1103406 1128033 1127345 1098206 1098758 1132314 1138833 1138876 1137809 1104141 1164437 1148205 1148307 1148565 1148163 1148709 1149419 1158667 1180647 1138036 1139540 1139510 1037782 1098256 1041793 1041139 1119177 1117738 1190568 1044931 1044351 1040764 1160757 1147747 1097466 1159784 1148530 1151030 1174104 1110283 1101561 1152960 1136798 1186356 1186639 1188142 1186579 1186590 1099572 1102128 1059066 1101740 1134163 1186587 1049144 1085902 1086054 1151146 1089176 1080141 1095314 1109999 1042173 1031387 1038019 1038543 1190762 1160289 1160568 1167268 1196846 1151805 1164867 1077168 1172909 1065134 1177890 1139118 1124251 1182202 1190766 1195370 1139765 1139675 1078571 1169487 1154526 1131902 1192577 1174388 1177382 1179618 1186544 1178243 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1049620 1109410 1134...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 3, 2025
Recall initiation date: Jul 21, 2025
Center classification date: Aug 27, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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