Class IOngoingZ-2343-2025

Tandem Diabetes Care, Inc. recalls Battery Operated infusion pumps. t:slim X2 G5

Tandem Diabetes Care, Inc.San Diego, CA, United StatesReported Sep 3, 2025 · 10 months ago

Legal News Analyst · Sep 3, 2025

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished1 code

1000911

t:slim X2 GS Classic, Replacement, Refurbished1 code

1003808

t: slim X2, Basal-IQ, mg/dl1 code

1004219

Pump, t:slim X2, Clinical Use Only1 code

1004484

Pump, t:slim X2, Control-IQ1 code

1005611

Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement1 code

1005613

Pump, t:slim X2, Control-IQ, mg/dl1 code

1005615

Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement1 code

1005617

Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement1 code

1006379

Pump, t:slim X2, Control-IQ 7.41 code

1006402

Pump, t:slim X2, Control-IQ 7.4, Replacement1 code

1006406

Pump, t:slim X2, Control-IQ 7.41 code

1006408

Pump, t:slim X2, Basal-IQ1 code

1006419

Pump, t:slim X2, Basal-IQ, mg/dL1 code

1006420

Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement1 code

1006535

Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement1 code

1006537

Pump, t:slim X2, Control-IQ, mg/dl , Replacement1 code

1008255

Pump, t:slim X2, Control-IQ, mmoUL, Replacement1 code

1008256

Pump, t:slim X2, Basal-IQ, mmoUL, Replacement1 code

1008257

Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement1 code

1008258

Pump, t:slim X2, Basal-IQ1 code

1010004

Pump, t:slim X2, Basal-IQ, Replacement1 code

1010005

Pump, t:slim X2, Basal-IQ, Medicare1 code

1010006

Pump, t:slim X2, Basal-IQ, Medicare1 code

1010007

Pump, t:slim X2, Control-IQ1 code

1010009

Pump, t:slim X2, Control-IQ Replacement1 code

1010010

Pump, t:slim X2, Control-IQ, Medicare1 code

1010011

Pump, t:slim X2, Control-IQ, Refurbished Replacement1 code

1010012

Pump, t:slim X2, Control-IQ1 code

1012867

Pump, t:slim X2, Control-IQ, Medicare1 code

1012868

Pump, t:slim X2, Control-IQ, Replacement1 code

1012869

Pump, t:slim X2, Control-IQ 7.81 code

1013195

Pump, t:slim X2, Control-IQ 7.8, Medicare1 code

1013196

Pump, t :slim X2, Control-IQ 7.8, Replacement1 code

1013197

Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement1 code

1013198

Lot / code information

UDI: 1000911/t:slim X2 G5, Replacement, Refurbished/00853052007318; 1003808/t:slim X2 GS Classic, Replacement, Refurbished/ 00853052007981; 1004219/t: slim X2, Basal-IQ — +97 moreShow all
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 #: 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 1…Show all
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 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1089240 1044786 1050174 1127450 1051372 1085255 1084995 1098309 1063996 1098494 1060892 1041467 1040982 1132281 1019268 1136846 1138865 1040584 1041466 1034158 1167994 1030767 1030872 1028097 1088069 1148309 1094754 1094258 1095557 1109170 1079138 1154688 1129307 1117370 1121728 1112236 1129842 1038028 1139532 1167107 1132327 1132871 1046471 1049938 1044325 1046565 1046564 1050219 1127590 1055444 1161899 1171637 1061294 1189986 1190593 1064898 1059461 1109196 1190998 1113847 1152496 1109208 1041407 1041427 1023013 1033115 1032409 1174373 1184801 1186628 1128584 1135284 1136631 1139728 1139139 1191337 1193055 1191584 1190739 1031121 1028166 1169532 1177589 1174320 1132865 1133050 1133066 1128536 1177786 1178743 1098255 1120100 1184807 1085097 1101946 1133946 1138817 1139310 1122071 1185606 1085624 1086793 1088003 1052447 1038695 1106503 1041455 1038079 1037491 1148174 1028206 1043709 1040735 1151381 1043039 1027142 1072103 1097921 1097858 1159873 1117464 1100615 1104217 1187916 1077458 1050400 1102546 1141218 1128104 1113002 1085984 1095329 1051040 1115605 1052544 1098977 1074138 1148055 1132301 1136965 1138765 1041090 1188435 1188531 1051922 1190303 1177860 1029585 1195324 1182299 1187987 1188086 1149405 1115558 1151447 1044354 1152129 1057291 1041275 1038086 1060564 1133413 1060325 1190571 1077524 1189551 1098054 1056414 1103886 1154504 1133046 1094886 1132349 1134204 1139218 1113760 1141155 1148273 1164002 1063494 1085954 1106589 1089272 1190549 1111378 1199209 1106029 1152398 1125187 1122241 1095339 1121226 1174387 1159322 1034564 1186414 1186434 1186695 1085212 1085996 1086062 1139585 1143409 1117530 1150664 1046461 1095525 1050221 1113299 1056972 1044808 1038618 1037893 1040139 1040321 1128621 1128738 1160499 1124362 1125406 1125412 1168090 1064612 1161981 1161850 1159817 1190014 1043955 1190554 1191489 1163817 1038869 1156941 1190596 1194938 1124421 1034507 1139312 1190574 1046076 1177468 1028402 1068857 1099456 1098683 1186496 1044838 1100561 1187964 1186187 1169622 1132079 1137698 1065972 1149210 1146554 1069931 1067479 1024742 1031087 1072323 1119171 1077619 1037833 1103990 1100662 1100466 1102989 1101036 1134244 1041149 1139603 1046299 1142858 1078771 1174301 1174374 1177452 1146633 1199251 1085985 1085226 1085894 1046818 1161628 1094147 1068465 1162288 1038471 1072180 1188393 1072527 1185512 1190016 1019613 1191375 1067950 1073201 1041501 1132992 1076960 1124746 1132847 1044421 1103924 1102352 1124716 1097939 1167884 1134466 1134190 1138711 1102578 1034728 1109924 1149188 1086035 1149548 1151394 1188087 1186350 1029532 1072247 1031238 1086465 1176903 1184435 1099369 1133054 1037832 1030675 1109724 1068650 1044439 1044436 1044727 1044611 1128117 1127691 1123578 1153155 1161425 1038767 1093990 1119254 1109199 1188010 1113467 1117360 1197840 1188498 1027732 1041409 1040093 1044609 1044703 1068991 1030818 1161773 1189870 1159552 1161365 1162154 1077060 1095841 1102502 1104200 1102135 1150870 1033805 1134529 1034421 1133771 1148250 1149268 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Additional code information

1151911 1162058 1167849 1167856 1167897 1175659 1180067 1171379 1170646 1174248 1172914 1172492 1173071 1129497 1129604 1129724 1127722 1128254 1129502 1129594 1113565 1126042 1129925 1130972 1124946 1129860 1131331 1131499 1131551 1163565 1163825 1157567 1158070 1167727 1175548 1175733 1175821 1175885 1180108 1162781 1167241 1178888 1180736 1170640 1173432 1171722 1171700 1112242 1112494 1112551 1113102 1113123 1130234 1112698 1113454 1130006 1130569 1181161 1181163 1181636 1046154 1149824 1181346 1190773 1172459 1173284 1124188 1130241 1131423 1131513 1131831 1173270 1173486 1171003 1186070 1176689 1177619 1176867 1176819 1176816 1177445 1179523 1177434 1177564 1178345 1177666 1181185 1182801 1181474 1181576 1181602 1191156 1191335 1111316 1111405 1111933 1112820 1128406 1131440 1131655 1182404 1174746 1173361 1057445 1059547 1047581 1046902 1047175 1056501 1056190 1052563 1055665 1059762 1058701 1058407 1047256 1059197 1072089 1071848 1092760 1071963 1092943 1074859 1092745 1071805 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1043025 1044772 90852738 1073660 1111269 1111364 1111536 1111701 1111708 1112354 1112366 1031635 1033326 1031843 1041502 1041476 1041572 1019026 1041512 1042242 1042486 1043151 1043614 1043079 1043335 1042778 1168307 1168868 1168823 1166615 1167511 1169677 1074715 1075608 1123991 1168248 1169293 1169219 1168558 1165532 1062164 1119888 1165808 1165737 1166763 1166288 1170181 1171819 1175247 1174672 1175260 1172307 1178224 1173177 1163388 1178678 1112568 1112651 1112924 1131556 1168212 1168180 1167568 1166650 1168835 1075363 1168878 1169122 1168535 1168485 1168323 1166405 1166433 1165911 1166279 1166424 1112505 1124856 1125852 1125934 1026931 1114791 1119535 1119785 1145813 1157620 1158210 1159084 1170277 1170257 1159191 1159062 1159860 1159438 1172130 1172903 1172540 1171750 1176359 1178261 1168903 1168609 1168619 1168399 1168633 1166023 1169169 1171245 1171404 1170726 1171397 1168239 1169778 1130980 1131161 1131203 1163099 1145365 1145529 1145772 1158127 1162231 1175706 1175797 1176061 1180056 1170538 1171713 1071490 1172446 1172422 1172465 1174884 1175815 1177450 1177539 1178517 1178801 1173644 1177851 1169683 1170119 1178011 1178040 1179561 1179801 1179856 1058708 1060665 1072809 1071883 1092750 1071979 90918689 1131134 1131201 1124801 1124820 1125198 1125322 1119467 1181335 1181436 1182716 1181483 1190791 1146139 1157578 1157590 1157617 1158229 1159404 1131224 1131582 1131642 1159861 1159072 1168221 1169533 1170575 1170429 1170494 1170460 1170699 1171291 1171240 1171178 1171350 1170408 1172929 1171777 1174938 1171574 1173021 1173899 1173171 1173387 1130860 1131049 1131342 1131833 1163184 1163345 1163528 1163702 1163715 1151732 1168254 1168258 1179993 1180220 1159787 1161662 1162839 1171905 1171148 1170612 1170722 1170780 1171738 1174126 1172096 1160096 1176576 1176777 1177587 1176930 1176942 1176969 1179515 1178552 1177136 1181216 1181254 1180608 1181079 1118725 1177802 1177767 1178087 1170122 1170365 1173546 1048514 1057248 1057649 1072400 1139662 1145775 1145468 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1173548 1173627 1175226 1177590 1177959 1178050 1178071 1177114 1179491 1179620 1179731 1179785 1179868 1059265 1059286 1054639 1054737 1073211 1092942 1074865 1074112 1092678 1074154 92749974 90652904 1058488 1059323 1071988 1092824 1072828 1092881 1092776 1074389 1092423 1071088 1047166 1092581 1024152 1030318 1029838 1027227 1027272 1027004 1028843 1026552 1033205 1030607 1033443 1028623 1058050 1059879 1057407 1138355 1138045 1173220 1173363 1173587 1177887 1178052 1178249 1161711 1161779 1169934 1170002 1171654 1175540 1144866 1145533 1145585 1145049 1145045 1155579 1017518 1025269 1017577 1024282 1023921 1023201 1024768 1018074 1019056 1023767 1024807 1180444 1173373 1173621 1173691 1175024 1177581 1177850 1161678 1144879 1145176 1145438 1145348 1127955 1126362 1128716 1129486 1129518 1129745 1112999 1125651 1046814 1017012 1053190 1053163 1055019 1056447 1055731 1046511 1059736 1112234 1109561 1111263 1111336 1111363 1112533 1129436 1127901 1129504 1113706 1177777 90756355 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1168434 1168186 1168772 1168086 1169605 1166496 1075602 1124895 1169156 1169038 1169134 1168571 1168712 1168484 1168797 1164937 1166431 1165673 1112892 1165804 1166449 1166011 1170501 1174936 1174748 1171992 1178588 1172952 1176626 1075730 1111083 1122079 1124282 1124346 1124788 1124843 1125101 1125183 1125184 1125401 1125692 1119678 1125748 1144657 1138627 1156666 1158642 1158963 1168507 1169483 1168970 1182541 1170844 1170030 1170544 1172112 1169236 1169604 1170420 1169780 1169283 1172043 1170281 1172038 1172098 1171793 1171549 1174548 1125112 1125164 1125298 1130978 1131093 1131349 1131500 1160919 1162651 1163083 1163187 1163243 1163262 1157699 1162104 1175711 1158651 1161721 1171088 1170691 1170922 1171884 1173411 1171768 1173026 1026475 1045759 1046607 1047555 1032023 1033195 1032087 1028349 1039571 1040157 1041644 1042003 1042158 1042367 1042623 1041751 1129561 1129711 1129718 1129824 1130677 1043065 90949606 1094053 1106628 1107144 1107040 90633598 90824883 1111255 1111313 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1144585 1139242 1145354 114357 …

What the firm is doing

On 7/21/2025, correction notices were mailed or emailed to customers were informed of the following: Confirm whether your pump is affected with serial number lookup: www.tandemdiabetes.com/mal16-2025 1) If you haven't had a Malfunction 16, continue using your Tandem pump as described in the User Guide, but with added precautions because the Malfunction 16 can occur at any time. 2) Use the Tandem t:slim mobile app with push notifications turned on so if the malfunction does occur, you will be notified by the app. If you need assistance with enabling smartphone notifications to receive alerts from your mobile app, go to support page: https://www.tandemdiabetes.com/support-center/software-and-apps/tandem-tslim-mobile-app/article/enable-smartphone-notifications-to-receive-alerts 3) If you are using a Dexcom sensor, use the Dexcom mobile app as a secondary means of CGM alerts and alarms. If you are unable to download and use the Tandem t:slim mobile app and/or your Dexcom mobile app, please contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com for support. 4) If you receive a Malfunction 16 alert: a. Promptly acknowledge it by pressing "Silence Alarm". b. Contact Tandem at 1-877-801-6901 or Techsupport@tandemdiabetes.com to arrange for a replacement pump. c. Switch to your backup method of insulin delivery as directed by your physician. 5) Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings. 6) Be prepared with a backup method of insulin delivery as directed by your physician, as set forth in the pump training, and as laid out in the pump user guide. 7) Complete the correction notice response form: campaign.tandemdiabetes.com/FCA-Malfunction-16 Firm is releasing a software update aimed at enhancing early detection of speaker failure and will notify users when available. If you have concerns, call 1-877-801-6901 or email Techsupport@tandemdiabetes.com.

DistributionShow details

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

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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