{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216615",
      "product_res_number": "Z-0574-2026",
      "event_date_initiated": "2025-10-08",
      "event_date_posted": "2025-11-20",
      "recall_status": "Open, Classified",
      "res_event_number": "97803",
      "product_code": "OWQ",
      "k_numbers": [
        "K043453"
      ],
      "product_description": "Brand Name: Sterilmed Reprocessed Imaging Catheter\nProduct Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM\nModel/Catalog Number: ACU10135936\nSoftware Version: N/A\nProduct Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM\nComponent: N/A",
      "code_info": "Lot Code: GTIN:  10888551004732\nLOT#         SERIAL#:\n2188147     131065\n2207154     916179\n2220232     1050886\n2234795     1170283",
      "firm_fei_number": "3011276773",
      "recalling_firm": "Sterilmed, Inc.",
      "address_1": "5010 Cheshire Pkwy N Ste 2 5010 Cheshire Pkwy N",
      "address_2": "Ste 2",
      "city": "Plymouth",
      "state": "MN",
      "postal_code": "55446-4101",
      "additional_info_contact": "Melissa Schultz\n763-488-3400",
      "reason_for_recall": "Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.",
      "root_cause_description": "Reprocessing Controls",
      "action": "Initial phone call notification was performed 10/10/2025 to affected customers. Customers were instructed to immediately stop use of identified devices. Affected products should be segregated.\n\nFollow-up written notification was sent to customers on 10/17/25 which included instructions on how to return affected products.",
      "product_quantity": "4",
      "distribution_pattern": "United States Only:  Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah",
      "openfda": {
        "k_number": [
          "K230584",
          "K043453",
          "K202042",
          "K232130",
          "K231621",
          "K173262",
          "K250545",
          "K063076",
          "K250592",
          "K190478",
          "K234064",
          "K170474",
          "K210655",
          "K121913",
          "K092425",
          "K230934",
          "K230928",
          "K231588",
          "K153090",
          "K161700",
          "K243101",
          "K254149",
          "K232584",
          "K033436",
          "K222217",
          "K223026",
          "K110076",
          "K182238",
          "K163560",
          "K181126",
          "K012537"
        ],
        "device_name": "Reprocessed Intravascular Ultrasound Catheter",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2",
        "registration_number": [
          "3011276773",
          "2011171",
          "3019807891",
          "2030404",
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        ],
        "fei_number": [
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        ]
      }
    }
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}