MiniMed 630G Insulin Pump (U.S
Medical device recall Z-1353-2022. Published in FDA’s Enforcement Report on Jul 20, 2022.
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 Jul 20, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 53 states named in where it went
- 126,558 pumps 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?
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MiniMed 630G Insulin Pump (U.S. and Canada Version)
126,558 pumps, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number/CFN (U.S. and Canada Version) MiniMed 630G (MMT-1515, MMT-1714, MMT-1715, MMT-1755, MMT-1754) UDI-DI Codes: 643169656840 763000090197 763000190439 763000316631 763000072520 763000166519 763000256807 763000316655 763000367053…
Every code shown here, 1,997 characters
Product Number/CFN (U.S. and Canada Version) MiniMed 630G (MMT-1515, MMT-1714, MMT-1715, MMT-1755, MMT-1754) UDI-DI Codes: 643169656840 763000090197 763000190439 763000316631 763000072520 763000166519 763000256807 763000316655 763000367053 643169752726 763000101527 763000157043 763000190446 763000317591 643169873841 643169878648 763000179632 763000317621 763000367091 Serial Numbers: U.S. NG1383785H NG2148562H NG1139337H NG1737004H NG1259251H NG1774415H NG1241089H NG1188783H NG1187471H NG1980564H NG1256182H NG2840625H NG2116702H NG2844148H NG2783673H NG1810845H NG2112005H NG2640743H NG2035194H NG2458619H NG2354215H NG2781208H NG2244550H NG1965419H NG2185247H NG2498398H NG1250806H NG1276438H NG2860063H NG2218677H NG2113185H NG2767104H NG2180341H NG1130892H NG2071932H NG2264667H NG1795581H NG2400221H NG2293843H NG2104120H NG2124365H NG2890094H NG2252300H NG1650442H NG1325260H NG1153291H NG2400741H NG2482730H NG2158681H NG1758986H NG2613364H NG1156096H NG1440806H NG2845051H NG1553883H NG1546328H NG1155957H NG1523937H NG2843050H NG1892069H NG2845095H NG2845838H NG2353176H NG2313508H NG2785450H NG1439520H NG2412244H NG1964235H NG1253487H NG2385855H NG2799938H NG2175012H NG2470945H NG2174440H NG2091991H NG1533482H NG1253547H NG2868078H NG2233832H NG2174831H NG1200880H NG1961918H NG2015551H NG2103196H NG2112652H NG2613904H NG2781907H NG2465094H NG2185535H NG2234148H NG2415957H NG2302136H NG2443157H NG1251498H NG2402685H NG1659773H NG2135502H NG2244532H NG3007109H NG2115596H NG1628832H NG1956533H NG1288367H NG1762590H NG2265232H NG2836889H NG1758770H NG1319868H NG2257844H NG2275710H NG1391082H NG1205208H NG1304902H NG1376503H NG2401703H NG2860186H NG2844624H NG2191969H NG2612458H NG2801688H NG1206727H NG1946546H NG1557575H NG1468728H NG1372439H NG1356382H NG1197326H NG2264976H NG1534634H NG2484177H NG1162032H NG1325140H NG1369904H NG2799758H NG2844942H NG1313176H NG2801122H NG1589073H NG2386272H NG2844253H NG1757801H NG1616912H NG2298323H NG1308832H NG1194280H NG2843240H…
FDA’s list runs to 1,392,577 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.
U.S.: 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY O.U.S.: Not provided
The states and territories these words name
53 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
- US Virgin Islands
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
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 May 23, 2022.
- FDA classified it on Jul 8, 2022.
- FDA’s Enforcement Report published it on Jul 20, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic MiniMed, of Northridge, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 1,392,577 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.