{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "cfres_id": "218887",
      "product_res_number": "Z-1681-2026",
      "event_date_initiated": "2026-02-18",
      "event_date_posted": "2026-03-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98482",
      "product_code": "LCJ",
      "k_numbers": [
        "K130813"
      ],
      "product_description": "CPX 4 US Breast Tissue Expanders with Suture Tabs\nReference Numbers: 354-9113, 3549313, 354-9314\nSILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)",
      "code_info": "00081317006671\n00081317006794\n00081317006800",
      "firm_fei_number": "1000118360",
      "recalling_firm": "Mentor Texas, LP.",
      "address_1": "3041 Skyway Cir N 3041 Skyway Cir",
      "city": "Irving",
      "state": "TX",
      "postal_code": "75038-3524",
      "additional_info_contact": "Mentor Resource Department\n7200-636-8678",
      "reason_for_recall": "Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On March 2, 2026, Mentor Worldwide LLC issued a  updated \"Urgent Medical Device Recall (Removal). The initial notification was issued on February 18, 2026. Mentor is asking consignees to take the following actions: \n\n1. Examine your inventory and quarantine immediately any affected products.\n2. Please maintain a copy of the notice with the quarantined product. \n3. Notify all personnel who need to be made aware of the recall.\n4. Complete the Business Reply Form of this notice and fax\n877-223-7559 or email ethicon3910@sedgwick.com to Sedgwick within 3 business days.\n5. If you require any assistance with returning product, please contact Sedgwick at 877-546-7680 and reference Event # 3910",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of  Canada, Albania, Australia, \tAustria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, \tItaly, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, \tSpain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.",
      "openfda": {
        "k_number": [
          "K243836",
          "K903448",
          "K180826",
          "K801042",
          "K864184",
          "K982067",
          "K241918",
          "K963066",
          "K254126",
          "K152496",
          "K790842",
          "K844813",
          "K983792",
          "K833502",
          "K242963",
          "K070303",
          "K845036",
          "K983385",
          "K862203",
          "K884250",
          "K182335",
          "K870154",
          "K142998",
          "K150777",
          "K843704",
          "K211676",
          "K864185",
          "K905484",
          "K102806",
          "K161483",
          "K974209",
          "K771224",
          "K843678",
          "K884746",
          "K894495",
          "K854794",
          "K870754",
          "K865056",
          "K112534",
          "K862049",
          "K853014",
          "K182054",
          "K981852",
          "K011500",
          "K131692",
          "K842883",
          "K130813",
          "K161176",
          "K140383",
          "K221127",
          "K840464",
          "K894475",
          "K865033",
          "K143354",
          "K214124"
        ],
        "registration_number": [
          "3009976880",
          "3014279513",
          "1645337",
          "9681387",
          "3018544165",
          "2523676",
          "3005423519",
          "2011068",
          "9614279",
          "1424263",
          "9617229",
          "1720929",
          "1649518",
          "3012883202",
          "8043385",
          "2521402",
          "2182979",
          "3003915875",
          "3005288183",
          "3013764800",
          "2183744",
          "3017636737"
        ],
        "fei_number": [
          "3009976880",
          "3014279513",
          "3006108784",
          "3001236277",
          "3004521048",
          "3018544165",
          "3003767881",
          "2523676",
          "3003015552",
          "1000118360",
          "2011068",
          "1720929",
          "3012883202",
          "2521402",
          "2182979",
          "3003915875",
          "3005288183",
          "3006165545",
          "3013764800",
          "2183744",
          "3002808401",
          "3017636737"
        ],
        "device_name": "Tissue Expander And Accessories",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}