{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130993",
      "product_res_number": "Z-0419-2015",
      "event_date_initiated": "2014-10-21",
      "event_date_posted": "2015-06-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-03-03",
      "res_event_number": "69584",
      "product_code": "KNH",
      "pma_numbers": [
        "P870076"
      ],
      "product_description": "Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).",
      "code_info": "All lots",
      "firm_fei_number": "3003790304",
      "recalling_firm": "Gyrus Acmi, Incorporated",
      "address_1": "136 Turnpike Road",
      "city": "Southborough",
      "state": "MA",
      "postal_code": "01772-2118",
      "additional_info_contact": "Laura Storms\n484-896-5688",
      "reason_for_recall": "All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.",
      "root_cause_description": "Process control",
      "action": "Olympus sent an Urgent Medical Device Recall letter dated October 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Olympus requires you to take the following action: I. Immediately cease any further use of any affected product you have, 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 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit t or replacement to your facility y for any returned product. 3. Please note on the enclosed questionnaire that you have received this information. 4. Fax the completed questionnaire to 484-896-7128 regardless of whether you have any affected inventory at your facility. ln addition, if you may have further distributed this product, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter.",
      "product_quantity": "74,792 units",
      "distribution_pattern": "Worldwide distribution.  US Nationwide, Canada, Vietnam, and Europe",
      "openfda": {
        "pma_number": [
          "P870080",
          "P070022",
          "P870076",
          "P920046"
        ],
        "registration_number": [
          "3002807314",
          "3008812251",
          "9616675",
          "1314417",
          "8021955",
          "3011050570"
        ],
        "fei_number": [
          "3002807314",
          "1314417",
          "3002808293",
          "3002806976",
          "3003105967",
          "3011050570"
        ],
        "device_name": "Laparoscopic Contraceptive Tubal Occlusion Device",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.5380",
        "device_class": "3"
      }
    }
  ]
}