{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204703", "product_res_number": "Z-0632-2024", "event_date_initiated": "2023-08-25", "event_date_posted": "2024-01-04", "recall_status": "Open, Classified", "res_event_number": "93547", "product_code": "HNN", "product_description": "Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807", "code_info": "UDI-DI: 30886158000571;\nLot Number: 6054027", "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": "Aminah Crawford\n781-530-6377", "reason_for_recall": "One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT Field Safety Notice dated 8/25/23 was sent to customers.\n\nActions Required by You\nOur records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots.\n\nPLEASE perform the following actions:\n1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. Only destroy the knives in your inventory that have the incorrect bevel orientation (bevel down). If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers.\n2. Review the enclosed Business Reply Form (BRF) and indicate whether you have the affected product in your possession.\n3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) destroyed.\n4. Return the completed BRF and evidence of destruction of affected product to BVI by emailing the attached to BVICrescentKnife@Sedgwick.com\n\nBVI values your business and apologizes for the inconvenience this may have caused. Please direct any questions regarding credit to our customer service department by email and include in the subject line: Master Case PIR 00474923.\n\nCountry Customer Service Email\nUK UKCustomerSupport@bvimedical.com\nFR serviceclient@bvimedical.com\nDE/ AT Kundendienst@bvimedical.com\nIT servizioclienti@bvimedical.com\nROW ROWCustomerSupport@bvimedical.com", "product_quantity": "1980 units", "distribution_pattern": "International distribution to the countries of Belgium, China, France, Germany, Greece, Italy, Jordan, Lithuania, Netherlands, Oman, Poland, Spain, Sweden.", "openfda": { "k_number": [ "K851790", "K821440", "K832844", "K861334", "K831266", "K852706", "K881669", "K812450", "K760187", "K110166", "K861744", "K855050", "K853499", "K853403", "K841951", "K861732", "K860852", "K822112", "K791981", "K834546", "K853063", "K863665", "K873385", "K791980", "K760186", "K864290", "K830366", "K850049", "K860305", "K812620", "K781465", "K874056", "K922378", "K861491", "K812918", 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"3030447506", "3035708926", "1211998", "3003039352", "2523835", "3013398127", "2245304", "1000307733", "3005548740", "1000246164", "1929756", "3007290840", "1000347621", "3009504366", "3023017972", "1000140363", "1036836", "1643817", "2521877", "3004571672", "3007791573", "3004467263", "1000160162", "1935627", "2083373", "4324", "3033485955", "3013784566", "3026790897", "3002806816", "3006897996", "3009337401", "3003015552", "1928237", "6362", "1416891", "3010699884", "2916714", "3030446844", "3030451558", "1317628", "3015475307", "3015456951", "3002409980", "3015177648", "3002807310", "3008280537", "3010487482", "2027619", "3002808145", "3002806863", "3014680834" ], "device_name": "Knife, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4350", "device_class": "1" } } ] }