{
  "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": "Maple Grove",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97396",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "address_2": "N/A",
      "postal_code": "55311-1565",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.",
      "recall_number": "Z-2536-2025",
      "product_description": "Boston Scientific UroMax Ultra Kit, Material Numbers (UPN):    1.\tM0062251200,   2.\tM0062251210,   3.\tM0062251220,   4.\tM0062251230,   5.\tM0062251240,   6.\tM0062251260,   7.\tM0062251290,   8.\tM0062251300,   9.\tM0062251310.   10.\tM0062251350,   11.\tM0062251360,   12.\tM0062251370.    (Urology)",
      "product_quantity": "1369 units",
      "reason_for_recall": "The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.",
      "recall_initiation_date": "20250805",
      "center_classification_date": "20250905",
      "report_date": "20250917",
      "code_info": "1. M0062251200, GTIN 8714729341277, Lot Numbers:  35536688, 35538633, 35538634, 35543803, 35543804, 35572728, 35678100;  2. M0062251210, GTIN 8714729341284, Lot Numbers:  35274797, 35274799, 35277223, 35277224, 35294475, 35294476, 35584203, 35584215, 35656798, 35667482, 35667483;  3. M0062251220, GTIN 8714729341291, Lot Numbers:  35257438, 35535450, 35536202, 35547680, 35656799;  4. M0062251230, GTIN 8714729341307, Lot Numbers:  35266389, 35543805;  5. M0062251240, GTIN 8714729341314, Lot Numbers:  35690647;  6. M0062251260, GTIN 8714729341338, Lot Numbers:  35537838, 35537839.  7. M0062251290, GTIN 08714729341369, Lot Numbers: 35266391;  8. M0062251300, GTIN 08714729341376, Lot Numbers: 35275806, 35536992;  9. M0062251310, GTIN 08714729341383, Lot Numbers: 35536991;  10. M0062251350, GTIN 08714729341390, Lot Numbers: 35690648;   11. M0062251360, GTIN 08714729302421, Lot Numbers: 35257611, 35536990;  12. M0062251370, GTIN 08714729302438, Lot Numbers: 35294477, 35536689."
    }
  ]
}