Class I U.S. Food and Drug Administration

Tandem Diabetes Care, Inc. Battery Operated infusion pumps. t:slim X2 G5 recall: Insulin pumps manufactured with speakers from Revision A and B

Recall published 1+ years ago

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.

The hazard: Device malfunction

This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

What the notice says: 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.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2343-2025
Published
September 3, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Tandem Diabetes Care, Inc.
Product type
Medical devices
Units affected
171,750
Distribution
Nationwide
Made in
United States
Lot / code info
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 101967…
UPC codes
00853052007318, 00853052007981, 00853052007998, 00850006613304, 00850006613311, 00850006613328, 00850006613335, 00850006613731, 00850006613762, 00850006613786, 00850006613793, 00850006613809, 00850006613816, 00850006613823, 00850006613830, 00850018992671, 00850018992664, 00850018992657, 00850018992640, 00389152000015

Products covered by this recall

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

Check your product

The notice names 40 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00853052007318
  • 00853052007981
  • 00853052007998
  • 00850006613304
  • 00850006613311
  • 00850006613328
  • 00850006613335
  • 00850006613731
  • 00850006613762
  • 00850006613786
  • 00850006613793
  • 00850006613809
  • 00850006613816
  • 00850006613823
  • 00850006613830
  • 00850018992671
  • 00850018992664
  • 00850018992657
  • 00850018992640
  • 00389152000015

Model or item number

On the rating label, the box or the instruction sheet.

  • REF
  • 1004219
  • 1004484
  • 1005611
  • 1005615
  • 1006402
  • 1006406
  • 1006408
  • 1006419
  • 1006420
  • 1008255
  • 1008256
  • 1008257
  • 1008258
  • 1010004
  • 1010005
  • 1010006
  • 1010007
  • 1010009
  • 1010010

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Tandem Diabetes Care, Inc. — This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
  3. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  4. Report device problems to the FDA through MedWatch — that database is where this recall came from.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Tandem Diabetes Care, Inc. — 12400 High Bluff Dr, San Diego, CA, 92130-3077

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Tandem Diabetes Care, Inc. medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00853052007318, 00853052007981, 00853052007998; model number REF, 1004219, 1004484. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls