Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported February 19, 2014
T:slim Insulin Delivery System Insulin Infusion Pump
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 …
Tandem Diabetes Care Inc recalled T:slim Insulin Delivery System Insulin Infusion Pump - a critical-severity action.
T:slim Insulin Delivery System Insulin Infusion Pump was recalled by Tandem Diabetes Care Inc in February 19, 2014. Reason: Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A…. Check the official notice for the remedy. Verify recall #Z-0827-2014 with the FDA Devices before acting.
The recall
Tandem Diabetes Care Inc issued this critical-severity FDA Devices recall-Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A….
- Critical
- severity level
- Class I
- classification
- February 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0827-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0827-2014) was formally reported on February 19, 2014, with the manufacturer initiating the action on January 10, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Tandem Diabetes Care Inc is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 12, 807 boxes (10packs).
The documented reason for this recall is: 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 seri… Distribution data in the federal record shows the product reached: USA (nationwide). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12, 807 boxes (10packs)
Related Recalls
6
3 from same agency
Product description
T:slim Insulin Delivery System Insulin Infusion Pump
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0827-2014 |
| Date reported | February 19, 2014 |
| Date initiated | January 10, 2014 |
| Recalling firm | Tandem Diabetes Care Inc |
| Firm location | San Diego, CA |
| Affected scope | 12, 807 boxes (10packs) |
| Distribution | USA (nationwide) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0827-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
T:slim Insulin Delivery System Insulin Infusion Pump. Recalled by Tandem Diabetes Care Inc. Units affected: 12, 807 boxes (10packs).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2014. Severity: Critical. Recall number: Z-0827-2014.
Where was the recalled product distributed? ▼
Distribution: USA (nationwide).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0827-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 19, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.