{
  "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": {
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  "results": [
    {
      "cfres_id": "189683",
      "product_res_number": "Z-0229-2022",
      "event_date_initiated": "2021-10-08",
      "event_date_created": "2021-11-16",
      "recall_status": "Open, Classified",
      "res_event_number": "88826",
      "product_code": "OJK",
      "product_description": "bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component\nREF# 58000572\n\nREF#: 373809",
      "code_info": "Lot Numbers 6032947 and 6033588\nUDI:\n\"\tPrimary: 00886158019961 \n\"\tSecondary: 30886158019962 \n\"\tTertiary: 50886158019966",
      "firm_fei_number": "1211998",
      "recalling_firm": "Beaver Visitec International, Inc.",
      "address_1": "500 Totten Pond Rd 10 City Point",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1916",
      "additional_info_contact": "SAME\n781-906-7950",
      "reason_for_recall": "Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades",
      "root_cause_description": "Under Investigation by firm",
      "action": "BVI notified Consignees  by Urgent Medical Device Recall letter on 10/8/21 via registered mail. Letter states reason for recall, health risk and action to take:\n1. Immediately examine your inventory and quarantine product from these lots that are subject to recall.\nIf you have further distributed this product, please notify your customers by initiating a subrecall.\nConsider all potential users of this product in your user supply chain. You are encouraged to a copy of this recall notification letter when contacting your customers.\n2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return.\n3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned.\n4. Return the completed BRF to BVI by one of these methods:\n\" Fax to 866-552-4919\n\" Email the attached to beavervisitec3997@sedgwick.com\n5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label:\nStericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241\nAttn: Event 3997\nIf you received this notification without the prepaid UPS label and Business Reply Form (BRF), and require additional shipping labels, or if you have questions regarding the return procedure, please contact Stericycle Inc. at 866-606-8264 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time).\nPlease direct any questions regarding this matter to our customer service department by email ClaimsUS@bvimedical.com and please include in the subject line: Master Case PIR 263383",
      "product_quantity": "125 eaches",
      "distribution_pattern": "Nationwide\nForeign:\nAustralia\nAustria\n France\n Germany\n Netherlands\n Spain\nJapan\nRussia \nSouth Africa\nUK",
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        "device_name": "Eye Tray",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4790",
        "device_class": "2"
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}