Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 10, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recomme…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic MiniMed, Inc. recalled InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) - a moderate-severity action.
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) was recalled by Medtronic MiniMed, Inc. in September 10, 2025. Reason: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that c…. Check the official notice for the remedy. Verify recall #Z-2496-2025 with the FDA Devices before acting.
The recall
Medtronic MiniMed, Inc. issued this moderate-severity FDA Devices recall-Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that c….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- September 10, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2496-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2496-2025) was formally reported on September 10, 2025, with the manufacturer initiating the action on June 16, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic MiniMed, Inc. is listed as the recalling firm, operating out of Northridge, CA. Federal records list the affected scope as 6816.
The documented reason for this recall is: Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value.… Distribution data in the federal record shows the product reached: International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Irela…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6816
Related Recalls
6
3 from same agency
Product description
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Reason for recall
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2496-2025 |
| Date reported | September 10, 2025 |
| Date initiated | June 16, 2025 |
| Recalling firm | Medtronic MiniMed, Inc. |
| Firm location | Northridge, CA |
| Affected scope | 6816 |
| Distribution | International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, L… |
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-2496-2025) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users). Recalled by Medtronic MiniMed, Inc.. Units affected: 6816.
Why was this product recalled? ▼
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2496-2025.
Where was the recalled product distributed? ▼
Distribution: International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2496-2025) 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 September 10, 2025. 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.