{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Sylmar",
      "address_1": "15900 Valley View Ct",
      "reason_for_recall": "The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.",
      "address_2": "",
      "product_quantity": "0",
      "code_info": "Software Versions: 24.0.1 rev 1",
      "center_classification_date": "20180629",
      "distribution_pattern": "U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,",
      "state": "CA",
      "product_description": "Merlin PCS Programmer Software: 3330    The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.",
      "report_date": "20180711",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "St Jude Medical Inc.",
      "recall_number": "Z-2335-2018",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "80244",
      "termination_date": "20210204",
      "more_code_info": "",
      "recall_initiation_date": "20180416",
      "postal_code": "91342-3577",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}