{ "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": "210322", "product_res_number": "Z-0261-2025", "event_date_initiated": "2024-09-16", "event_date_posted": "2024-10-30", "recall_status": "Open, Classified", "res_event_number": "95454", "product_code": "CBI", "k_numbers": [ "K203749" ], "product_description": "Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)", "code_info": "Lot Codes:\nVivaSight 2 DLT Kit 35 Fr - lot no. 1000891667 to lot. no 1001021855;\nVivaSight 2 DLT Kit 37 Fr - lot. no. 1000887909 to lot no. 1001021861;\nVivaSight 2 DLT Kit 39 Fr - lot. no. 1000916871 to lot no. 1001021917;\nVivaSight 2 DLT Kit 41 Fr - lot. no. 1000934084 to lot. no. 1001011434", "firm_fei_number": "1121788", "recalling_firm": "Ambu Inc.", "address_1": "6721 Columbia Gateway Dr Ste 200 6721 Columbia Gateway Dr", "address_2": "Ste 200", "city": "Columbia", "state": "MD", "postal_code": "21046-3380", "additional_info_contact": "Sanjay Parikh\n800-2628462", "reason_for_recall": "Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.", "root_cause_description": "Under Investigation by firm", "action": "An Urgent Medical Device Correction letter dated 9/24/24 was sent to customers.\n\nAdvise on actions to be taken by user:\nOur records indicates that your facility has purchased the Ambu VivaSight 2 DLT products and you may have affected devices in your stock.\n\nPlease identify if any of your in stock Ambu VivaSight 2 DLT products falls within the affected expiration date and lot numbers range listed on page 1 of this Field Safety Notice. If so, you must visually inspect these products as per below graphics before use to ensure that the distal end is not hyper-angulated.\n\n1. View the blue tip of the Vivasight 2. This can be done without taking the product out of the pouch.\n2. Compare the angle (bend) of the tip with the pictures shown above.\n3. The bend in the tip should be as shown like in Pictures 1 to 3.\n4. If the bend is determined to be similar to Pictures 4, 5 or 6, they should not be used.\nIf hyper-angulation is identified, you must discard the impacted Ambu VivaSight 2 DLT product. \n\nIf your facility prefers not to inspect affected products and would like to return them, please indicate that on Appendix 1. Ambu will issue RMA Number for your return.\n\nAmbu will compensate you by either replacing the units with a new Ambu VivaSight 2 DLT, an aScope 4 broncho slim, which can be used with a conventional DLT or providing a credit.\n\nPlease note that Ambu VivaSight 2 DLT products shipped from Ambu after September 04, 2024, should not be considered affected.\n\nPlease return your confirmation of the actions described in the Field Safety Notice (Appendix 1) within 2 weeks of receipt of this letter.\n\nTransmission of this Field Safety Notice:\nThis notice needs to be passed on to all those who need to be aware within your organization and/or to any organization where the devices could have been transferred/shipped.\n\nPlease forward this notice to other organizations on which this action may have an impact.\n\nAlso, please maintain awareness on this notice and resulting action f", "product_quantity": "1824", "distribution_pattern": "US Nationwide. Canada.", "openfda": { "k_number": [ "K141888", "K201026", "K051522", "K253096", "K002288", "K083883", "K120334", "K251950", "K232580", "K962167", "K897046", "K160542", "K093888", "K181886", "K851856", "K121462", "K021920", "K222340", "K092886", "K200968", "K232529", "K953483", "K010596", "K013865", "K152251", "K180253", "K894337", "K071694", "K203749", "K961977", "K111522", "K925615", "K123853", "K113576" ], "registration_number": [ "3003898360", "3006017180", "3009093866", "3014656749", "3018094310", "2011171", "3004040397", "3013023209", "1000563940", "1314417", "3011137372", "3013528571", "3007134520", "9617604", "3006425876", "3004748541", "1423662", "2032112", "3006984712", "2936999", "3004784537", "3010220595", "3010131137", "2025816", "3007797756", "8040412", "9681384", "3010400865", "3014766734", "9610691", "3000308637", "3005609751", "3009171251", "1820334", "3004111573", "3012050423" ], "fei_number": [ "3003898360", "3006017180", "3003076831", "3009093866", "3014656749", "3018094310", "2011171", "3004040397", "3013023209", "1000563940", "1314417", "3013528571", "3009271244", "3007134520", "3006425876", "3004748541", "3002806359", "3002807626", "3006984712", "2936999", "3006759904", "3004784537", "3010220595", "3010131137", "3000215273", "2025816", "3007797756", "3005747797", "3010400865", "3014766734", "3000308637", "3005609751", "3002558692", "1820334", "3004111573", "3012050423" ], "device_name": "Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5740", "device_class": "2" } } ] }