{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220844",
      "product_res_number": "Z-2676-2026",
      "event_date_initiated": "2026-06-05",
      "event_date_posted": "2026-07-07",
      "recall_status": "Open, Classified",
      "res_event_number": "99106",
      "product_code": "FDT",
      "k_numbers": [
        "K220587"
      ],
      "product_description": "Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid",
      "code_info": "UDI/DI: 04953170441271, Lot Numbers: H2530 or later",
      "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": "Ashley Mitch\n484-553-1029",
      "reason_for_recall": "Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.",
      "root_cause_description": "Device Design",
      "action": "Olympus issued an UREGNT:  MEDICAL DEVICE REMOVAL notice to it consignees on 6/5/2026 via 2nd day courier.  The notice explained the issue, risk to heath, and requested the following be taken:  \n\"1.\tExamine your inventory for the previous design of the Single Use Distal Covers, model MAJ-2315 (see Fig.1-6 above and list of affected lot numbers).  \n2.\tAll older versions of this product should be returned to Olympus and replaced with the newly designed version.  \n\"\tTransition to the newly designed version as soon as possible by placing an order through Customer Service at 1-800-848-9024, option 2.  \n3.\tOnce you have received the new design of the MAJ-2315, stop using the previous design and set aside for return.  \n\"\tTo return the older version, please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will issue a credit to your facility upon return of the previous design.  \n4.\tOlympus requests that you acknowledge receipt of this letter through our recall web portal:  \n\"\tGo to https://olympusamerica.com/recall  \n\"\tEnter the recall number \"XXXX   \n\"\tComplete the form as instructed.   \n\"\tPlease indicate in your response if you no longer have the device(s).    \n5.\tPlease forward this notice to other users who may have the affected products if you have further distributed it.\"  \n\nFor additional information...",
      "product_quantity": "988700 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
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        ],
        "device_name": "Duodenoscope And Accessories, Flexible/Rigid",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
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