Class I recallOngoing

Tandem t:slim X2 insulin pumps recall — FDA event 97003

FDA · FDA event 97003 · Posted Aug 27, 2025

Published Aug 27, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references Tandem t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc..

Products affected by FDA event 97003
Model	Description	Lot / serial range	Manufactured	Status
Z-2343-2025	Z-2343-2025	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… See the official FDA source for the complete identifier list.	Not provided in the normalized record	Ongoing

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
Units affected: See official FDA record
Category: Insulin pumps

Timeline

Jul 21, 2025
Recall initiated
Date recorded by the FDA.
Aug 27, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 97003
Published: Aug 27, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Loading MedWatcher information…

Tandem t:slim X2 insulin pumps recall — FDA event 97003

FDA · FDA event 97003 · Posted Aug 27, 2025

Published Aug 27, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

Products affected by FDA event 97003
Model	Description	Lot / serial range	Manufactured	Status
Z-2343-2025	Z-2343-2025	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… See the official FDA source for the complete identifier list.	Not provided in the normalized record	Ongoing

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

Units affected

See official FDA record

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403

FDA · FDA event 97403Posted Oct 23, 2025Tandem Mobi Insulin Pump,Tandem t:slim X2 Insulin Pump

Class I recallOngoing

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417

FDA · FDA event 96417Posted Apr 11, 2025Tandem Mobi Insulin Pump,Tandem t:slim X2 Insulin Pump

Tandem t:slim X2 insulin pumps recall — FDA event 97003

Follow Tandem t:slim X2 Insulin Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Tandem t:slim X2 insulin pumps recall — FDA event 97003

Follow Tandem t:slim X2 Insulin Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline