{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95586",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "600 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-4835",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay.",
      "recall_number": "Z-0482-2025",
      "product_description": "Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems:  Plum 360\" Infusion System, Pump List Number\t30010; Plum A+ & Plum A+3\" Infusion Systems, Pump List Numbers:  11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197",
      "product_quantity": "3840",
      "reason_for_recall": "ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems.  Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.",
      "recall_initiation_date": "20241022",
      "center_classification_date": "20241121",
      "report_date": "20241127",
      "code_info": "All batteries WITHOUT the following information on the label:  1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery):  W2401xxxx - W2406xxx"
    }
  ]
}