{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218643",
      "product_res_number": "Z-1551-2026",
      "event_date_initiated": "2026-02-10",
      "event_date_posted": "2026-03-11",
      "recall_status": "Open, Classified",
      "res_event_number": "98412",
      "product_code": "PIF",
      "k_numbers": [
        "K150679"
      ],
      "product_description": "EndoVive Safety PEG Kit;\nOuter Box Material Number (UPN): M00509001;\nInner Box Material Number (UPN): M00509000;",
      "code_info": "Outer Box Material Number (UPN): M00509001;\nInner Box Material Number (UPN): M00509000;\nOuter Box UDI: 08714729880394;\nInner Box UDI: 08714729880387;\nOuter Box Lot#s: 37435463, 37522541, 37528545, 37546847, 37546850, 37546849, 37550500, 37592036, 37732292;\nInner Box Lot#s: 37435462, 37514809, 37525231, 37536563, 37536564, 37536562, 37546840, 37583642, 37731897;",
      "firm_fei_number": "3005099803",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "city": "Marlborough",
      "state": "MA",
      "postal_code": "01752-1234",
      "additional_info_contact": "Renee Archie\n508-683-4523",
      "reason_for_recall": "Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit\ncomponents. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.",
      "root_cause_description": "Process control",
      "action": "On February 10, 2026 Urgent Medical Device Removal - Immediate Action Required letters were sent to customers.\nActions to be taken:\n\" Do NOT use affected product (Attachment 1), remove affected product from your facility s\ninventory, and segregate the units in a secure place until they can be returned to Boston\nScientific.\n\" Immediately post this information in a visible location near the affected products to ensure this\ninformation is readily accessible to all handlers and users of the device.\n\" Forward this notice to any healthcare professional from your organization for awareness and to\nany organization where affected devices have been transferred.\n\" Complete and return the enclosed Reply Verification Tracking Form per the enclosed\ninstructions.\n\" Return affected product.\nThis removal affects only the products and lots affected. No other\nmaterial numbers or lots are impacted by this removal. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them.",
      "product_quantity": "806 units",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "Gastrointestinal Tubes With Enteral Specific Connectors",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5980",
        "device_class": "2"
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    }
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}