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Use caution Medical device recall · FDA · Published November 15, 2023

Medtronic Guardian 4 Glucose Sensor Recall: Glucose Sensor Glucose Value Errors

Medtronic recalls Guardian 4 Glucose Sensors with specific model numbers and lot codes due to potential glucose value errors that could cause hyperglycemia or hypoglycemia.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1005-2024Medical deviceMedtronic ›
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Recalling firmMedtronic MiniMed, Inc.18000 Devonshire St · Northridge, CA 91325-1219
✎ GovInfoNow plain-language explainer

Medtronic is recalling certain Guardian 4 Glucose Sensors that may have a glucose oxidase layer thickness outside specifications. This could lead to inaccurate glucose readings, potentially causing dangerous blood sugar levels if the sensor is not functioning properly. Read more at govinfonow.com/recall/56849-medtronic-guardian-4-glucose-sensor-recall-glucose-sensor-glucose-value.

Source Summary by GovInfoNow · govinfonow.com/recall/56849-medtronic-guardian-4-glucose-sensor-recall-glucose-sensor-glucose-value · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1005-2024

Cite this page

“Medtronic Guardian 4 Glucose Sensor Recall: Glucose Sensor Glucose Value Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56849-medtronic-guardian-4-glucose-sensor-recall-glucose-sensor-glucose-value. Based on FDA recall #Z-1005-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1005-2024%22&limit=1).

The FDA announced on 2023-11-15 that Medtronic MiniMed, Inc. is recalling Guardian 4 Glucose Sensors due to a glucose oxidase layer thickness defect. This issue may cause inaccurate glucose readings or sensor failure, potentially leading to improper insulin delivery. Owners should contact the company for a replacement.

How to tell if you have it

  • Brand: Medtronic
  • Product: Guardian 4 Glucose Sensor
  • REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
  • Lot codes: HG72B2C, HG72CQQ, HG73VB7, HG73VC8, HG73VFT, HG73WFR, HG7441E, HG745F9, HG7486X, HG74AJ1, HG74SUR, HG74T9Q, HG74U36, HG78LMS, HG79Y9U (REF MMT-7040A); F1323, F1923, G0323, G1723, G2023, G2623, G2923, HG6RV7S, HG6TGNU, HG6TJ2Y, HG6TW97, HG6TWVU, HG6UNF2, HG6V8NN, HG6VB8S, HG6VNX3, HG6WNE1, HG6XFPR, HG6XH54, HG6XQCG, HG6XZJX, HG6Y0W1, HG6Y3QN, HG6YEK6, HG6YFAF, HG6YFHL, HG6YJAR, HG6YJBD, HG6YNGD, HG6Z7N5, HG6ZARN, HG7038Y, HG70CW5, HG70DAM, HG70JSU, HG70LRC, HG70QWA, HG71VMZ, HG72DB5, HG72G9C, HG72NV9, HG72R1P, HG72RBD, HG72SE3, HG72TPT, HG72TRV, HG72V3J, HG72ZFP, HG7340A, HG73EJX, HG73RNR, HG745SV, HG747E3, HG7480Q, HG749N6, HG74F93, HG75TSX, HG75XA1, HG76HFH, HG76RYY (REF MMT-7040C1); HG6RC39, HG6RXB5, HG6T4T7, HG6T8RV, HG6TJ2Y, HG6WKZU, HG6WLKS, HG6XFPR, HG6XH54, HG6XLSD, HG6XNH3, HG6Y5C6, HG6Z1X5, HG713AK, HG73EGX, HG73EJX, HG73FJP, HG73Q24, HG73QPM, HG73RNR, HG7619X, HG764J9, HG76CWC, HG77FMK (REF MMT-7040C2); HG6XNH3, HG73RNR (REF MMT-7040C3); HG6THY1, HG6V7VV (REF MMT-7040D1); HG6TL44 (REF MMT-7040D2); HG74460 (REF MMT-7040MA); HG6WT9A, HG6WUGE, HG73PH3 (REF MMT-7040QC1); HG6WT9A (REF MMT-7040QC2); HG6WT9A (REF MMT-7040QC3)

The hazard

According to the FDA, some sensors may have a glucose oxidase layer thickness outside of specification. A non-conforming layer could impact sensor function or cause loss of function due to the layer being too thin. The potential impact ranges from user inconvenience to over- or under-delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia.

Context

GovInfoNow's records show Medtronic MiniMed, Inc. has 13 other recalls on record since 2024-07-31. Recent recalls include the 2026-07-13 Medtronic MiniMed 640G Insulin Pump Recall for risk of incorrect insulin delivery and the 2026-06-16 Medtronic MiniMed Go App Version 1.0.0/1.1.0 recall for missed insulin doses. Other recent recalls of similar products include the 2025-11-24 FreeStyle Libre 3 Plus Sensor Recall and the 2025-11-24 FreeStyle Libre 14 Day Sensor Recall.

How to tell if you have this one

Check if your Guardian 4 Glucose Sensor has model numbers MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, or MMT-7040MA. The specific lot codes and reference numbers are listed in the recall notice.

  • Brand
    Medtronic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Sensor Model

    Verify your Guardian 4 Glucose Sensor model number against the list of affected models provided in the recall notice.

  2. Contact Medtronic

    Reach out to Medtronic for guidance on whether your sensor is affected and what steps to take next.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 47 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - US Nationwide distribution including in the states of PR, AK, AL, AR, AZ, CA, CO, CT, FL, GA, 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, RI, SC, SD, TN, TX, UT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Nov 15, 202312. FDA classified it Class II: Feb 7, 202423. Published in FDA’s Enforcement Report: Feb 14, 2024320232024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Abbott FreeStyle Libre 3 Sensors: Erroneous High Glucose Readings Risk Hypoglycemia
AbbottFreeStyle Libre 14 Day Sensor Recall: Class I Recall for Abbott Diabetes Care Sensors
FreeStyle LibreDexcom G7 Sensors Recalled: Risk of Skin Infection and Inaccurate Readings
DexcomMedtronic MiniMed 630G System Recall: Loose Reservoir Risk
MedtronicSafeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLC

Other Medtronic recalls

Medtronic MiniMed, Inc. recalls Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product
August 20, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
July 13, 2026Medtronic MiniMed, Inc. recalls MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
June 16, 2026Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
May 27, 2026Medtronic MiniMed, Inc. recalls MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
February 13, 2026Medtronic MiniMed, Inc. recalls MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
January 30, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1005-2024 (November 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1005-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA