Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 2, 2019
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc. recalled Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx… - a moderate-severity action.
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx… was recalled by Medtronic Inc. in January 2, 2019. Reason: Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio s…. Check the official notice for the remedy. Verify recall #Z-0683-2019 with the FDA Devices before acting.
The recall
Medtronic Inc. issued this moderate-severity FDA Devices recall-Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio s….
- Moderate
- severity level
- 143K units
- affected scope
- Class II
- classification
- January 2, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0683-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0683-2019) was formally reported on January 2, 2019, with the manufacturer initiating the action on October 3, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Inc. is listed as the recalling firm, operating out of Northridge, CA. Federal records list the affected scope as 142889, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens … Distribution data in the federal record shows the product reached: US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, VT, SC, SD, TN, TX, UT, VA, Virgin Island,…. 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 - 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 - 40,422 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
142889
Related Recalls
6
0 from same agency
Product description
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Reason for recall
Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0683-2019 |
| Date reported | January 2, 2019 |
| Date initiated | October 3, 2018 |
| Recalling firm | Medtronic Inc. |
| Firm location | Northridge, CA |
| Affected scope | 142889 |
| Distribution | US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, VT, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and… |
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-0683-2019) 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? ▼
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International). Recalled by Medtronic Inc.. Units affected: 142889.
Why was this product recalled? ▼
Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0683-2019.
Where was the recalled product distributed? ▼
Distribution: US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, VT, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0683-2019) 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 January 2, 2019. 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.