{ "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": "203367", "product_res_number": "Z-0108-2024", "event_date_initiated": "2023-09-12", "event_date_posted": "2023-10-12", "recall_status": "Open, Classified", "res_event_number": "93071", "product_code": "LFL", "k_numbers": [ "K211838" ], "product_description": "THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S.\nModel: TB-0535FCS\nIndicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed", "code_info": "UDI-DI: 4953170409677\nLot Numbers:\nKR271978\t\nKR314612\t\nKR314613\t\nKR314615\t\nKR314617\t\nKR314618\t\nKR314619\t\nKR314621\t\nKR314622\t\nKR314623\t\nKR314624\t\nKR314626\t\nKR314627\t\nKR314628\t\nKR314629\t\nKR314630\t\nKR314631\t\nKR314632\t\nKR314633\t\nKR314634\t\nKR314638\t\nKR314640\t\nKR314641\t\nKR314644\t\nKR314647\t\nKR314648\t\nKR314650\t\nKR314651\t\nKR314652\t\nKR314654\t\nKR314655\t\nKR314657\t\nKR314659\t\nKR314660\t\nKR314662\t\nKR314663\t\nKR314668\t\nKR314670\t\nKR314671\t\nKR314672\t\nKR314673\t\nKR314674\t\nKR314675\t\nKR314676\t\nKR314679\t\nKR316617\t\nKR316627\t\nKR316629\t\nKR316637\t\nKR316683\t\nKR319616\t\nKR319643\t\nKR319655\t\nKR332609\t\nKR332615\t\nKR332616\t\nKR332623\t\nKR332626\t\nKR335733\t\nKR335754\t\nKR335760\nKR335769\nKR335770\nKR335776\nKR335781\nKR335784\nKR335785\nKR335794\nKR335796\nKR335836\nPW308606\nPW308607\nPW308609\nPW308611\nPW308613\nPW308615\nPW308616\nPW308663\nPW308772\nPW308773\nPW308774\nPW308775\nPW308776\nPW308786\nPW308788\n\nLots Added January 11, 2024:\nKR271978\nKR314619\nKR314627\nKR314633\nKR314648\nKR335770\nKR310806\nKR314612\nKR314621\nKR314628\nKR314634\nKR332616\nKR335836\nKR310809\nKR314613\nKR314622\nKR314629\nKR314638\nKR332623\nKR333661\nKR314615\nKR314623\nKR314630\nKR314640\nKR332626\nKR342666\nKR314617\nKR314624\nKR314631\nKR314641\nKR335754\nKR314618\nKR314626\nKR314632\nKR314644\nKR335769", "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": "SAME\n484-896-5000", "reason_for_recall": "Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery", "root_cause_description": "Under Investigation by firm", "action": "UPDATE:\nOlympus issued a revised letter for additional lots titled: Correction to letter dated September 13, 2023- Additional Lot numbers on January 11, 2024. \n\nOlympus issued Urgent Medical Device Recall Letter on 9/13/23 to Healthcare Professional. Letter states reason for recall, health risk and action to take:\n1. Inspect your inventory and identify any THUNDERBEAT models and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. The lot number can be found on the box or pouch.\n\n2. Call your Olympus customer service representative at 1-800-848-9024, option 2, with the quantity, model, and lot number of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product.\n3. Access the Olympus recall portal to indicate that you have received this notification:\na. Go to https://olympusamerica.com/recall.\nb. Enter the recall number: 0431\n4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter.\n\nOlympus requests that you report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1.", "product_quantity": "2496 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K933559", "K864983", "K010637", "K020220", "K964742", "K981262", "K050885", "K172691", "K070313", "K003824", "K101797", "K072904", "K990430", "K172595", "K994280", "K983065", "K950945", "K231117", "K161882", "K211273", "K221235", "K221835", "K071669", "K050776", "K111741", "K072203", "K240493", "K960374", "K962525", "K821820", "K212750", "K042777", "K150682", "K192963", "K223770", "K233036", "K060245", "K151136", "K123640", "K202299", "K113570", "K021989", "K851203", "K261448", "K962584", "K041566", "K212614", "K101561", "K051036", "K153299", "K213824", "K880814", "K210567", "K921251", "K243930", "K151101", "K980895", "K012753", "K000927", "K062544", "K151340", 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"regulation_number": "", "device_class": "U" } } ] }