{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "218530",
      "product_res_number": "Z-1481-2026",
      "event_date_initiated": "2026-02-02",
      "event_date_posted": "2026-03-02",
      "recall_status": "Open, Classified",
      "res_event_number": "98380",
      "product_code": "LCJ",
      "product_description": "Brand Name: B. Braun\nProduct Name: BBraun Medical 21G X4.4CM Winged INF\nModel/Catalog Number: 7B3050\nSoftware Version: N/A\nProduct Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids.\nComponent: N/A",
      "code_info": "Model/Catalog Number: 7B3050;\nPrimary-DI 4046964341298, Unit of Use- DI 4046964341274; \nLot 0062006430, Exp 30APR2032; Lot 0062006470, Exp 30JUN2032; Lot 0062006471, Exp 31MAY2032; Lot 0062014964, Exp 31JUL2032; Lot 0062014965, Exp 31JUL2032; Lot 0062014966, Exp 30SEP2032; Lot 0062027579, Exp 31AUG2032.",
      "firm_fei_number": "2521402",
      "recalling_firm": "B Braun Medical Inc",
      "address_1": "824 12th Ave",
      "city": "Bethlehem",
      "state": "PA",
      "postal_code": "18018-3524",
      "additional_info_contact": "Allison Longenhagen\n001-484-2408373",
      "reason_for_recall": "The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.",
      "root_cause_description": "Process control",
      "action": "On February 2, 2026 URGENT MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. Actions to be taken:\n1. Review the notice in its entirety and ensure that all users in your organization are aware and informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the hospital/healthcare facility level.\n2. Examine inventory for affected product, cease use and quarantine product subject to recall. Do not destroy any affected product.\n5. Once we receive your Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs.",
      "product_quantity": "105550 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.",
      "openfda": {
        "k_number": [
          "K182335",
          "K963066",
          "K844813",
          "K182054",
          "K211676",
          "K864185",
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          "K870754",
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          "K870154",
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          "K862049",
          "K884746",
          "K974209",
          "K894475",
          "K983385",
          "K161176"
        ],
        "registration_number": [
          "1720929",
          "1424263",
          "3012883202",
          "9617229",
          "3009976880",
          "1649518",
          "3018544165",
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          "9681387",
          "3013764800",
          "3003915875",
          "8043385",
          "2521402"
        ],
        "fei_number": [
          "3003015552",
          "1720929",
          "3012883202",
          "3001236277",
          "3006108784",
          "3009976880",
          "3006165545",
          "3018544165",
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          "2183744",
          "3002808401",
          "2523676",
          "3005288183",
          "3014279513",
          "2011068",
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          "3017636737",
          "3004521048",
          "3003767881",
          "3013764800",
          "3003915875",
          "2521402"
        ],
        "device_name": "Tissue Expander And Accessories",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}