{ "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": 17 } }, "results": [ { "cfres_id": "215732", "product_res_number": "Z-0240-2026", "event_date_initiated": "2025-09-23", "event_date_posted": "2025-10-23", "recall_status": "Open, Classified", "res_event_number": "97479", "product_code": "JJQ", "product_description": "BD Veritor Connect Software, labeled as the following:\n\n1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.", "code_info": "Catalog Number (Serial Numbers): 444881, UDI/DI: 00382904448813, (SL00087, SL00098, SL01320, SL00083, SL00089, SL01002, SL01050, SL01522, SL00095, SL01480, SL01000, SL00551, SL01007, SL00062, SL01354, SL00097, SL01028, SL00066, SL00077, SL00084, SL00074, SL01080, SL00088, SL01038, SL01194, SL00106, SL01003, SL00108, SL00061, SL00073, SL01521, SL01081, 1022, SL00105, SL01033, SL01119, SL01018, SL00080).", "firm_fei_number": "1119779", "recalling_firm": "Becton Dickinson & Co.", "address_1": "7 Loveton Cir", "city": "Sparks", "state": "MD", "postal_code": "21152-9212", "additional_info_contact": "410-316-4000", "reason_for_recall": "Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.", "root_cause_description": "Software design", "action": "Beckton, Dickenson and Company notified consignees on about 09/23/2025 via mailed letter and email. This updated letter serves as a supplement to the original field action communication, dated 10/31/2024. It is intended to clarify that the previously described issue remains unchanged; however, the scope of the impacted product SKUs has been expanded. The update specifically documents additional SKUs including refurbished product codes that were not included in the original communication.\n\nConsignees were instructed to follow outlined best practices for maintaining strong security measures to protect hospital networks and medical devices, read and understand the recall notification, provide the letter to all applicable personnel or customers if further distributed, and complete and return the Customer Response Form.", "product_quantity": "38 units", "distribution_pattern": "Worldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.", "openfda": { "k_number": [ "K905762", "K903911", "K925203", "K850767", "K894423", "K770306", "K953572", "K900028", "K812865", "K941050", "K830101", "K811840", "K915113", "K922081", "K850709", "K901965", "K842947", "K781576", "K771909", "K893738", "K863959", "K844567", "K882938", "K844894", "K792647", "K915689", "K854210", "K891270", "K863802", "K900224", "K844418", "K915690", "K823512", "K883646", "K901027", "K800522", "K852481", "K772022", "K800523", "K914202", "K801044", "K884124", "K895967", "K851098", "K864566", "K873583", "K850708", "K891869", "K913590", "K834489", "K822050", "K932778", "K791102", "K811111", "K832531", "K823266", "K883302", "K860720", "K896007", "K910302", "K790422", "K780902", "K781241", "K782035", "K760232", "K953710", "K854303", "K791968", "K834099", "K803285", "K780903", "K841214", "K895102", "K864542", "K950029", "K962166", "K760233", "K925935", "K962113", "K842311", "K871874", "K931907", "K801957", "K811680", "K781544", "K832206", "K864201", "K873408", "K801564", "K843460", "K813563", "K850392", "K892063", "K881458", "K923158", "K942245", "K905215", "K770288", "K873893", "K900245", "K921536", "K913295", "K890854", "K902776", "K873678", "K873138", "K781269", "K920914", "K771807", "K801562", "K872749", "K801499", "K873638", "K923844", "K900579", "K771637", "K850994", "K882095", "K861223", "K843668", "K901695", "K791302", "K861194", "K871415", "K925625", "K810665", "K760672", "K881797", "K874262", "K760395", "K862908", "K910806", "K883435", "K831866", "K855149", "K955077", "K840340", "K864451", "K895313", "K881803", "K852047", "K850993", "K854540", "K852538", "K760737", "K841648", "K864634", "K932467", "K943454", "K862999", "K810511", "K802619", "K912368", "K915680", "K832397", "K874244", "K890502", "K900776", "K842770", "K850995", "K900372", "K821561", "K904783", "K830569", "K903164", "K811975", "K842085", "K943595", "K943701", "K961183", "K834150", "K873384", "K860987", "K894503", "K973938", "K822720", "K864060", "K903934", "K942250", "K950104", "K935983", "K910740", "K901059", "K912413", "K914906", "K894687", "K896117", "K803131", "K823590", "K921180", "K864285", "K801563", "K873451", "K820217", "K760553", "K953005", "K810736", "K820273", "K853453", "K901542", "K822800", "K974762", "K843296", "K891767", "K844419", "K013371", "K842474", "K872219", "K861897", "K940486", "K923456", "K850348", "K904567", "K922329", "K922976", "K871307", "K853284", "K801373", "K770278", "K980120", "K800057", "K851572", "K872324", "K894270", "K884782", "K942361", "K771496", "K781632", "K811806", "K855108", "K854679", "K884864", "K760112", "K861263", "K810105", "K852411", "K894859", "K913840", "K882608", "K781138", "K912959", "K942923", "K911438", "K792292", "K863566", "K823720", "K915896", "K861617", "K821439", "K901829", "K780156", "K864319", "K911045", "K801536", "K803030", "K881877", "K832364", "K841557" ], "registration_number": [ "", "3008517993", "2431980", "3004175381", "3043153468", "2182595", "3010399798", "3027344570", "8030478", "3003741796", "1000191380", "3050015", "3043138885", "2246703", "1000312377", "1217454", "1061932", "3002800697", "1627497", "1832216", "3002889627", "2245285", "3005652389", "1616487", "3018771894", "3010324880", "3013660430", "3005772418", "9617078", "3009238284", "3011394152", "3011240982", "3016245321", "3030234142", "1221020", "2032087", "2916205", "3007799234", "1050155", "3015969000", "3000279201", "1530958", "1181055", "3011246727", "3006198300", "9610806", "3017379203", "1117676", "3009046888", "3017132875", "1641328", "2915274", "9610102", "3003559191", "2020726", "1037998", "1827821", "3002710220", "2517506", "3043088937", "1119779", "2032598", "3022178699", "3006621318", "3035708936", "3014325803", "3021482081", "3004013603", "2024800", "2029372", "3006786907", "9681443", "1036223", "3006621353", "3026565854", "3008249922", "3043624347", "3017877290", "3006552587", "3006795781", "3002806944", "3007167099", "3027645317", "1219145", "3024820199", "2919016", "3014100717" ], "fei_number": [ "", "3008517993", "2431980", "3004175381", "3043153468", "2182595", "3010399798", "3027344570", "1000639866", "3003741796", "1000191380", "3050015", "1000306617", "3043138885", "2246703", "1000312377", "1217454", "3002800697", "1627497", "1832216", "3002889627", "2245285", "1616487", "3018771894", "3010324880", "3013660430", "3005772418", "3009238284", "3000203293", "3011394152", "3011240982", "3016245321", "3030234142", "1221020", "2916205", "3007799234", "1050155", "3015969000", "3002876349", "3000279201", "1181055", "3011246727", "3006198300", "3004846435", "3003355251", "1000166193", "3017379203", "1117676", "3009046888", "3003789989", "3017132875", "1641328", "2915274", "3003559191", "2020726", "1037998", "1827821", "3002710220", "2517506", "3002807786", "3043088937", "1119779", "3022178699", "3006621318", "3001576181", "3035708936", "3014325803", "3021482081", "3004013603", "2024800", "3006786907", "1036223", "3006621353", "3026565854", "3008249922", "3043624347", "3017877290", "3006552587", "3001644026", "3006795781", "3002806944", "3007167099", "3027645317", "1219145", "3024820199", "2919016", "3014100717" ], "device_name": "Colorimeter, Photometer, Spectrophotometer For Clinical Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2300", "device_class": "1" } } ] }