{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "205092",
      "product_res_number": "Z-1005-2024",
      "event_date_initiated": "2023-11-15",
      "event_date_posted": "2024-02-07",
      "recall_status": "Open, Classified",
      "res_event_number": "93675",
      "product_code": "OZP",
      "pma_numbers": [
        "P160017S091"
      ],
      "product_description": "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",
      "code_info": "REF/UDI-DI/Lot: MMT-7040A/20763000413389/HG72B2C, HG72CQQ, HG73VB7, HG73VC8, HG73VFT, HG73WFR, HG7441E, HG745F9, HG7486X, HG74AJ1, HG74SUR, HG74T9Q, HG74U36, HG78LMS, HG79Y9U; \n\nMMT-7040C1/00763000555276, 00763000413392, 20763000413396, 20763000555270, 20763000712475, 00763000712471/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; \n\nMMT-7040C2/20763000555287/HG6RC39, HG6RXB5, HG6T4T7, HG6T8RV, HG6TJ2Y, HG6WKZU, HG6WLKS, HG6XFPR, HG6XH54, HG6XLSD, HG6XNH3, HG6Y5C6, HG6Z1X5, HG713AK, HG73EGX, HG73EJX, HG73FJP, HG73Q24, HG73QPM, HG73RNR, HG7619X, HG764J9, HG76CWC, HG77FMK;\n \nMMT-7040C3/20763000555294/HG6XNH3, HG73RNR; \n\nMMT-7040D1/00763000413484/HG6THY1, HG6V7VV;\n \nMMT-7040D2/00763000413491/HG6TL44;\n \nMMT-7040MA/20763000519692/HG74460;\n \nMMT-7040QC1/00763000555313, 20763000555317/HG6WT9A, HG6WUGE, HG73PH3;\n \nMMT-7040QC2/20763000555324, 763000555320/HG6WT9A;\n \nMMT-7040QC3/20763000555331/HG6WT9A",
      "firm_fei_number": "3003166194",
      "recalling_firm": "Medtronic MiniMed, Inc.",
      "address_1": "18000 Devonshire St",
      "city": "Northridge",
      "state": "CA",
      "postal_code": "91325-1219",
      "additional_info_contact": "Medtronic 24-Hr Technical Support\n800-646-4633",
      "reason_for_recall": "Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected.  The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.",
      "root_cause_description": "Process change control",
      "action": "On 11/15/23, recall notices were mailed or emailed to patients, distributors, and healthcare professionals who were told the following:\n\n1) If you have affected devices discard and contact the firm to receive replacement sensors in the following ways:  by completing the web form at medtronicdiabetes.com/G4S-form, contacting 24-Hour Technical Support at 800-646-4633, option 1, or email rs.customerexperience@medtronic.com.\n2) If you cannot identify the LOT number of the sensor you are currently wearing, remove the sensor and replace your sensor with a non-impacted sensor.\n3) Please complete and return the confirmation form via email to rs.safetyinformation@medtronic.com\n\nDistributors were asked to either 1) notify impacted customers using the Correction Letter and provide status updates to the recalling firm regarding customer responses, or 2) provide the recalling firm with customer addresses so they can notify impacted customers.\n\nIf you have any questions, please contact the firm at 800-646-4633, option 1.",
      "product_quantity": "114,758",
      "distribution_pattern": "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, VA, WA, WI, WV, WY and the countries of Austria, Belgium, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Liechtenstein, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.",
      "openfda": {
        "pma_number": [
          "P160017"
        ],
        "registration_number": [
          "",
          "2134850",
          "3014498598",
          "3009171251",
          "3009882464",
          "3011393376",
          "3038419886",
          "3011121740",
          "3006371704",
          "3004167884",
          "1810909",
          "3014353045",
          "3012118659",
          "2032227",
          "1000134386",
          "3042027705"
        ],
        "fei_number": [
          "",
          "3006759904",
          "3003007876",
          "3014498598",
          "3009882464",
          "3010700165",
          "3011393376",
          "3038419886",
          "3006371704",
          "3004167884",
          "1810909",
          "3014353045",
          "3012118659",
          "3003166194",
          "1000134386",
          "3042027705"
        ],
        "device_name": "Automated Insulin Dosing Device System, Single Hormonal Control",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}