Severity
Moderate
FDA Devices recall · Reported August 5, 2015
Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion…
Medtronic MiniMed Inc. recalled MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 15… - a moderate-severity action.
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 15… was recalled by Medtronic MiniMed Inc. in August 5, 2015. Reason: Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios wh…. Check the official notice for the remedy. Verify recall #Z-2260-2015 with the FDA Devices before acting.
The recall
Medtronic MiniMed Inc. issued this moderate-severity FDA Devices recall-Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios wh….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2260-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2260-2015) was formally reported on August 5, 2015, with the manufacturer initiating the action on June 19, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic MiniMed Inc. is listed as the recalling firm, operating out of Northridge, CA. Federal records list the affected scope as 1936 units.
The documented reason for this recall is: Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no lo… Distribution data in the federal record shows the product reached: Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.. 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.
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.
Severity
Moderate
Affected scope
1936 units
Related Recalls
6
3 from same agency
MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.
Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2260-2015 |
| Date reported | August 5, 2015 |
| Date initiated | June 19, 2015 |
| Recalling firm | Medtronic MiniMed Inc. |
| Firm location | Northridge, CA |
| Affected scope | 1936 units |
| Distribution | Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom. |
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.
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.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
· 2026-07-02
· 2026-06-25
· 2026-06-18
GE Medical Systems Information Technologies Inc · 2026-06-03
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
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 August 5, 2015. 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.