# FDA recall Z-0594-2026

> **Medtronic MiniMed, Inc.** · Class II · device recall initiated 2025-10-21.

## Product

CareLink Clinic, REF: MMT-7350

## Reason for recall

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.

## Distribution

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), Urugua

## Key facts

- **Recall number:** Z-0594-2026
- **Recalling firm:** Medtronic MiniMed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-21
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northridge, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0594-2026

## Citation

> AI Analytics. FDA recall Z-0594-2026. Retrieved 2026-08-20 from https://api.ai-analytics.org/recall/Z-0594-2026. Source: US FDA. Licensed CC0.

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