{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "103394",
      "product_res_number": "Z-0040-2012",
      "event_date_initiated": "2011-08-12",
      "event_date_posted": "2011-10-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-09-19",
      "res_event_number": "59712",
      "product_code": "IWJ",
      "product_description": "Prostrate Seeding Applicator Needle. Product code PSS1820AT\nPacked in boxes of (25) with five Single Packs and four five packs or as singles or five packs.\nWorldwide Medical Technologies, LLC\n\nUsed to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate",
      "code_info": "Product code PSS1820AT Lot 116261,  Exp Date: 2016-06; and Lot 116589, Exp Date 2016-07",
      "firm_fei_number": "3000206637",
      "recalling_firm": "Worldwide Medical Technologies, LLC",
      "address_1": "115 Hurley Rd Ste 3b 115 Hurley Rd",
      "address_2": "Ste 3b",
      "city": "Oxford",
      "state": "CT",
      "postal_code": "06478-1047",
      "additional_info_contact": "203-262-4190 Ext. 105",
      "reason_for_recall": "Length of the cannula hub is  longer and may not permit a fit with the  Applicator",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "BrachySciences, a division of Biocompatibles, Inc., sent out \"Urgent Recall Device Recall\" letters Dated August 12, 2011 to all affected customers.\n\nThe letter included affected product and problem description.  Customers are asked to quarantine and return unused product.   A Product Recall & Retrieval Form was included to send back to the firm.\n\n\nFor questions on this recall contact the firm at (203) 262-0571, extension 105.",
      "product_quantity": "1872 units",
      "distribution_pattern": "Worldwide Distribution:  Nationwide distribution including the states of AR, CO, DE. FL, KY, MD, MI, MN, NY, TX, and VA; and the countries of Belgium, and Germany.",
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        ],
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        ],
        "device_name": "System, Applicator, Radionuclide, Manual",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5650",
        "device_class": "1"
      }
    }
  ]
}