Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961,…
Medical device recall Z-0110-2018. Published in FDA’s Enforcement Report on Nov 29, 2017.
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 Nov 29, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 1,513,530 units 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?
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
1,513,530 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: 5079672 5079674 5079675 5079697 5079698 5082268 5082622 5082773 5084125 5084460 5084464 5085187 5086974 5087586 5088981 5091305 5095068 5095069 5095177 5095195 5097241 5097967 5098225 5101297 5101624 5103311 5103312 5103409…
Every code shown here, 1,997 characters
Lot Numbers: 5079672 5079674 5079675 5079697 5079698 5082268 5082622 5082773 5084125 5084460 5084464 5085187 5086974 5087586 5088981 5091305 5095068 5095069 5095177 5095195 5097241 5097967 5098225 5101297 5101624 5103311 5103312 5103409 5103888 5104247 5104632 5106185 5109341 5109702 5109707 5109788 5109789 5109790 5109791 5115440 5115456 5117215 5117935 5119233 5119933 5122173 5122398 5123224 5123228 5123253 5123254 5127870 5127932 5129136 5130064 5130084 5131255 5131853 5131854 5132018 5132951 5133982 5134548 5135127 5135128 5135176 5139007 5140383 5140384 5141588 5143411 5143418 5143983 5143984 5146890 5147485 5148153 5148887 5149493 5150551 5150591 5151310 5151829 5152526 5152962 5153937 5154653 5156088 5156857 5157422 5158190 5158191 5161065 5162223 5162250 5162886 5163245 5163931 5163949 5166387 5167139 5167818 5167819 5169320 5169321 5174510 5176569 5176581 5177287 5178033 5180040 5180041 5068343 5119941 5127869 5127940 5140277 5140347 5150562 5153947 5162256 5165229 5167006 5169334 5175719 5180060 5078337 5079699 5079702 5082269 5082270 5082627 5082774 5082775 5084126 5084127 5084462 5085476 5086923 5087587 5087588 5088385 5088386 5088612 5088613 5088982 5088983 5088984 5088985 5091306 5091307 5095070 5095071 5095072 5095181 5095183 5095196 5095197 5096419 5096420 5096423 5097242 5097968 5098226 5098599 5098828 5099489 5099719 5099720 5100589 5100590 5101625 5101626 5103313 5103314 5103315 5103889 5104633 5104634 5105363 5105364 5105437 5106827 5106828 5107548 5109709 5109711 5109792 5109793 5109794 5109795 5109796 5115441 5115444 5115454 5115455 5117039 5117216 5117267 5117936 5117937 5117938 5117939 5118541 5119234 5119663 5119934 5120632 5120633 5122399 5122400 5122401 5122402 5123226 5123227 5127871 5128409 5128411 5128412 5128413 5128448 5128449 5129142 5130065 5130066 5130067 5131256 5131257 5131855 5131856 5131857 5131858 5132095 5132099 5132952 5132953 5133983 5133984 5134433 5134549 5134550 5135129 5135130 5135131 5136421 5137569 5137570 5137881…
FDA’s list runs to 11,508 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.
Worldwide
These words name no state.
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 Sep 10, 2017.
- FDA classified it on Nov 18, 2017.
- FDA’s Enforcement Report published it on Nov 29, 2017.
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: Press Release.
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 11,508 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
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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.