Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

T:slim Insulin Delivery System Insulin Infusion Pump Recalled by Tandem Diabetes Care Inc Due to Specific lots of insulin cartridges that are used...

Date: January 10, 2014
Company: Tandem Diabetes Care Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tandem Diabetes Care Inc directly.

Affected Products

T:slim Insulin Delivery System Insulin Infusion Pump

Quantity: 12, 807 boxes (10packs)

Why Was This Recalled?

Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tandem Diabetes Care Inc

Tandem Diabetes Care Inc has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report