{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176436",
      "product_res_number": "Z-0159-2020",
      "event_date_initiated": "2019-09-12",
      "event_date_created": "2019-10-17",
      "recall_status": "Open, Classified",
      "res_event_number": "83826",
      "product_code": "HHI",
      "k_numbers": [
        "K030935"
      ],
      "product_description": "Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity.\nPart# 54298-10/pack",
      "code_info": "Lot number: 494604",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "address_2": "PO Box 610",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-0610",
      "additional_info_contact": "SAME\n484-896-5000",
      "reason_for_recall": "Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate",
      "root_cause_description": "Process control",
      "action": "Olympus issued notification letter on 9/12/19 via Federal Express two day delivery stating reason for recall, health risk and action to take: 1.\tImmediately assess any affected product you have in stock, remove it from your inventory and quarantine it until it is shipped back to us. 2.Call your Olympus customer service representative at 1-888-524-7266 option 1.   Olympus will issue a Return Material Authorization in order to return any affected product at no charge to you.  Olympus will issue a credit or replacement to your facility for your affected product.. 4.Fax the completed Reply form to Olympus Market Quality at 484-896-7128 regardless of whether you have any affected inventory at your facility.\nContact 484-896-5688 or at laura.storms@olympus.com for any additional information concerning this matter.",
      "product_quantity": "1106 boxes (10 filters/box)",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K840384",
          "K813282",
          "K870560",
          "K862476",
          "K800833",
          "K840382",
          "K983181",
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          "K904160",
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          "K840952",
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          "K831112",
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          "K840381",
          "K841631",
          "K850312",
          "K840383",
          "K030935",
          "K171440",
          "K873552"
        ],
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        "fei_number": [
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          "1450908",
          "3004458261",
          "3013557562",
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        ],
        "device_name": "System, Abortion, Vacuum",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.5070",
        "device_class": "2"
      }
    }
  ]
}