Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported May 15, 2024
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bl…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Tandem Diabetes Care, Inc. recalled t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ tec… - a critical-severity action.
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ tec… was recalled by Tandem Diabetes Care, Inc. in May 15, 2024. Reason: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating …. Check the official notice for the remedy. Verify recall #Z-1609-2024 with the FDA Devices before acting.
The recall
Tandem Diabetes Care, Inc. issued this critical-severity FDA Devices recall-During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating ….
- Critical
- severity level
- Class I
- classification
- May 15, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1609-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1609-2024) was formally reported on May 15, 2024, with the manufacturer initiating the action on March 5, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Tandem Diabetes Care, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 85,863 applications.
The documented reason for this recall is: During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in… Distribution data in the federal record shows the product reached: US nationwide distribution including Puerto Rico.. 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
85,863 applications
Related Recalls
6
3 from same agency
Product description
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Reason for recall
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1609-2024 |
| Date reported | May 15, 2024 |
| Date initiated | March 5, 2024 |
| Recalling firm | Tandem Diabetes Care, Inc. |
| Firm location | San Diego, CA |
| Affected scope | 85,863 applications |
| Distribution | US nationwide distribution including Puerto Rico. |
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-1609-2024) 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:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology. Recalled by Tandem Diabetes Care, Inc.. Units affected: 85,863 applications.
Why was this product recalled? ▼
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2024. Severity: Critical. Recall number: Z-1609-2024.
Where was the recalled product distributed? ▼
Distribution: US nationwide distribution including Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1609-2024) 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 May 15, 2024. 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.