FDA-Device2025-12-03Class IIPROCESSING DEFECT
CareLink Clinic, REF: MMT-7350
OTHERNationwide distribution
Hazard
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
Sold states
Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA, VA, ID, WA, GA, MI, MA, OH, IL, IA, CT, FL, PA, NY, TN, AZ, LA, AL, NJ, CO, SC, MS, OR, MT, MD, KS, AK, NH, NE, WY, ND, IN, MO, WI, KY, UT, NV, SD, WV, NM, HI, AR, OK, VT, RI; and OUS (foreign) to countries of: Australia (AU), Sweden (SE), Belgium (BE), Great Britain (GB), Netherlands (NL), Finland (FI), Canada (CA), Germany (DE), Spain (ES), Switzerland (CH), Italy (IT), South Africa (ZA), South Korea (KR), Singapore (SG), New Zealand (NZ), Poland (PL), Israel (IL), Denmark (DK), Norway (NO), Luxembourg (LU), Lithuania (LT), Czech Republic ( CZ), Mexico (MX), Brazil (BR), Colombia (CO), Slovakia (SK), Ireland (IE), Argentina (AR), Greece (GR), Kuwait (KW), Portugal (PT), Iceland (IS), Japan (JP), Turkey (TR), Austria (AT), Qatar (QA), Hong Kong (HK), Chile (CL), Ukraine (UA), Hungary (HU), Estonia (EE), RS, Latvia (LV), Taiwan (TW), Saudia Arabia (SA), Bahrain (BH), Oman (OM), Romania (RO), India (IN), Uruguay (UY), Malaysia (MY), United Arab Emirates (AE), Algeria (DZ), Croatia (HR), France (FR), Russia (RU), Cyprus (CY), Thailand (TH), Egypt (EG), Bosnia and Herzegovina (BA), Libya (LY), and Iraq (IQ)
Affected count
12126
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
CareLink Clinic, REF: MMT-7350
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0594-2026More Medtronic MiniMed, Inc. recalls
- FDA-Device2026-04-08Medtronic MiniMed insulin pumps recalled for incorrect insulin delivery based on pump position
- FDA-Device2026-04-08Medtronic MiniMed Paradigm insulin pumps recalled for incorrect insulin delivery based on pump position
- FDA-Device2026-04-08Medtronic MiniMed insulin pumps recalled for incorrect insulin delivery based on pump position
- FDA-Device2026-04-08Medtronic MiniMed insulin pumps recalled for incorrect insulin delivery based on pump position
- FDA-Device2026-04-08Medtronic MiniMed insulin pumps recalled for incorrect insulin delivery based on pump position
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