Medtronic MiniMed 630G 6025805-003_C
Medical device recall Z-0683-2019. Published in FDA’s Enforcement Report on Jan 2, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 2, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 52 states named in where it went
- 142889 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
142889, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers NG1330099H NG1330154H NG1329859H NG1330107H NG1330110H NG1330113H NG1330122H NG1330133H NG1330136H NG1330140H NG1330142H NG1330143H NG1330145H NG1330160H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H…
Every code shown here, 1,995 characters
Serial Numbers NG1330099H NG1330154H NG1329859H NG1330107H NG1330110H NG1330113H NG1330122H NG1330133H NG1330136H NG1330140H NG1330142H NG1330143H NG1330145H NG1330160H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1330145H NG1330160H NG1330160H NG1330145H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1399727H NG1399183H NG1399310H NG1400412H NG1399761H NG1399740H NG1399750H NG1400409H NG1400138H NG1400067H NG1400445H NG1400080H NG1400332H NG1400078H NG1400458H NG1400416H NG1400350H NG1400420H NG1400003H NG1399926H NG1400448H NG1400674H NG1400159H NG1399266H NG1400140H NG1400562H NG1400509H NG1400346H NG1399206H NG1400293H NG1400164H NG1399776H NG1399708H NG1399738H NG1400077H NG1399562H NG1399623H NG1399101H NG1399268H NG1398858H NG1399624H NG1399345H NG1399574H NG1399614H NG1398932H NG1398948H NG1399462H NG1399530H NG1399210H NG1399441H NG1399997H NG1400051H NG1400054H NG1400106H NG1400292H NG1399923H NG1400072H NG1399663H NG1399669H NG1400151H NG1400353H NG1400410H NG1400434H NG1399757H NG1399680H NG1399890H NG1399622H NG1399674H NG1399613H NG1399892H NG1399015H NG1399389H NG1399467H NG1398249H NG1398312H NG1399185H NG1398301H NG1399497H NG1398015H NG1398434H NG1398130H NG1398062H NG1398063H NG1399103H NG1399175H NG1399107H NG1399352H NG1399527H NG1399176H NG1399443H NG1399472H NG1399202H NG1399057H NG1399182H NG1399271H NG1398692H NG1398937H NG1398670H NG1398550H NG1398795H NG1398647H NG1398751H NG1398667H NG1398555H NG1398646H NG1400170H NG1400154H NG1400282H NG1400160H NG1400148H NG1400438H NG1400482H NG1399894H NG1400512H NG1400481H NG1398852H NG1400471H NG1400513H NG1400569H NG1400206H NG1400477H NG1400575H NG1400068H NG1400572H NG1400480H NG1400344H NG1400473H NG1400453H NG1397889H NG1397914H NG1398297H NG1397901H NG1399354H NG1399284H NG1399633H NG1399445H NG1399495H NG1399413H NG1399636H NG1399054H NG1399020H NG1399195H…
FDA’s list runs to 1,784,548 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
52 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 3, 2018.
- FDA classified it on Dec 22, 2018.
- FDA’s Enforcement Report published it on Jan 2, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., of Northridge, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 1,784,548 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.