{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "198981",
      "product_res_number": "Z-1418-2023",
      "event_date_initiated": "2023-02-23",
      "event_date_posted": "2023-04-20",
      "recall_status": "Open, Classified",
      "res_event_number": "91840",
      "product_code": "MND",
      "k_numbers": [
        "K013066"
      ],
      "product_description": "Single Use Rotatable Clip Fixing Device\n\nModel HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip\nModel HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip\nModel HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip",
      "code_info": "1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV\n\n2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V\n\n3) UDI-DI 14953170353120; Model HX-201UR-135; Lot 24V\n\n4) UDI-DI 14953170353168; Model HX-201UR-135L; Lot 24V",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-8229",
      "additional_info_contact": "Cynthia Ow\n484-896-5000",
      "reason_for_recall": "There have been complaints that the clip did not come out of the tube sheath during the procedure.",
      "root_cause_description": "Process change control",
      "action": "The firm, Olympus, sent an \"URGENT: MEDICAL DEVICE RECALL\" letter dated 2/23/2023 to its customers. The letter described the product, the issue and actions to be taken. The customers were instructed to do the following:\n1) immediately assess, cease use of and quarantine any affected (lot numbers) products you have identified.\n2.) Call your Olympus customer service representative at 1-800-848-9024, option 2 to receive a RMA to return any affected product at not charge.\n3.)Access the Olympus recall portal to indicate that you have received this notification at https://olympusamerica.com/recall. Enter the recall number \"0421\" and provide your contact information as indicated in the portal.\n4.) If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. \n\nPlease report to Olympus any adverse events and irregularity associated with the use of the devices by contacting our Technical Assistance Center at 1 800 848 9024, option 1.\n\nPlease reach out to your local sales representative for assistance regarding current product offerings.\n\n If you require additional information, please do not hesitate to contact me at \n(647) 999-3203 or Cynthia.Ow@Olympus.com.",
      "product_quantity": "65.9 boxes (373 pieces)",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K001744",
          "K944220",
          "K081142",
          "K051950",
          "K013066",
          "K033245",
          "K964661",
          "K971137",
          "K083556",
          "K984255",
          "K132535",
          "K940661",
          "K031236",
          "K022434",
          "K990864"
        ],
        "registration_number": [
          "3011050570",
          "9614641",
          "3010188783",
          "3008797804",
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          "1037905",
          "3014769442",
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          "3010138349",
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        ],
        "fei_number": [
          "3011050570",
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          "3010188783",
          "3008797804",
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          "3003995201",
          "3013557562",
          "3002807969",
          "1000305720",
          "3030733800",
          "3001451571",
          "3007695959"
        ],
        "device_name": "Ligator, Esophageal",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4400",
        "device_class": "2"
      }
    }
  ]
}