Agency classClass IOur severity:Critical FDA (Devices)·Z-2343-2025·Announced 2025-09-03

Insulin pumps recalled over malfunction that stops insulin delivery and alerts

Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this insulin pump malfunction as Class I.

Plain-English summary

Battery operated t:slim X2 infusion pumps are being recalled across a wide range of references, including REF 1000911 (t:slim X2 G5 replacement refurbished), 1003808 (t:slim X2 G5 Classic replacement refurbished), 1004219 (t:slim X2 Basal-IQ mg/dl), 1004484 (clinical use only), 1005611, 1005613, 1005615 and 1005617 (Control-IQ variants), 1006379 (Basal-IQ 6.4 refurbished replacement) and 1006402 and 1006406 (Control-IQ 7.4). The recall covers 171,750 units distributed in the United States including Puerto Rico and in more than 20 other countries.

Insulin pumps manufactured with speakers from Revision A and B may experience a malfunction identified as "Malfunction 16". The manufacturer states this prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin, which could result in a hyperglycemic event that may lead to injury and/or hospitalization. The FDA classified the action as Class I, its most serious category.

Pump users should check their pump against the recall notice and follow the manufacturer's instructions, keeping a backup insulin delivery method available. Anyone whose pump has stopped delivering insulin should contact their healthcare provider.

The recalled product

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…
Manufacturer: Tandem Diabetes Care, Inc.
Category: Medical Device — Insulin Pump
Hazard: device-malfunction
insulin-delivery-stop
alert-failure
hyperglycemia
class-i
Affected units: 171,750

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

REF/UDI-DI: 1000911/t:slim X2 G5
Replacement
Refurbished/00853052007318
1003808/t:slim X2 GS Classic
Refurbished/ 00853052007981
1004219/t: slim X2
Basal-IQ
mg/dl/ 00853052007998
1004484/Pump
t:slim X2
Clinical Use Only
1005611/Pump
Control-IQ
mmoUL/ 00850006613304/
1005613/Pump
mmoUL
Refurbished Replacement/ 00850006613311/
1005615/Pump
mg/dl/ 00850006613328/
1005617/Pump

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Tandem Diabetes Care, Inc.

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