{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
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      "product_res_number": "Z-0284-2027",
      "event_date_initiated": "2026-09-23",
      "event_date_posted": "2026-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "99947",
      "product_code": "GAQ",
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      "product_description": "ETHILON Nylon Suture, Product Code 697G",
      "code_info": "GTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS",
      "firm_fei_number": "2648650",
      "recalling_firm": "Ethicon, LLC",
      "address_1": "Highway 183 Km 8.3",
      "city": "San Lorenzo",
      "postal_code": "00754",
      "country": "PR",
      "additional_info_contact": "787-783-7070",
      "reason_for_recall": "Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.",
      "root_cause_description": "Process control",
      "action": "On 9/3/2026, field safety notices were mailed to customers who were asked to do the following:\n\n1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records.\n2. Return affected product to firm.\n3. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return and forward them this recall notice.\n4. Complete and return the Business Reply Form (BRF) via email to RA-ITSUS-JJMCanada@ITS.JNJ.com",
      "product_quantity": "4,003",
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        "device_name": "Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4495",
        "device_class": "2"
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}