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Recall Observatory FDA recall evidence

Device product

BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475

Z-0596-2025

October 31, 2024

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 95636
Status
Ongoing
Classification
Class II
Quantity
584 units (313 US, 271 OUS)
Official record key
device-enforcement:Z-0596-2025

Official wording

Reason: BD confirmed that 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.

Code information: Catalog No: 445475; UDI-DI: 00382904454753; Serial Numbers: DB5631, DB 6970, DB6857, DB6859, DB6122, DB3043, MD1710, DB4372, DB6043, DB2249, DB5030, DB2882, DB3090, MD2046, DB4927, DB5825, DB2828, DB2835, DB3251, DB3245, DB6893, DB3145, DB3211, DB5876, DB5906, DB4284, DB5948, DB3143, DB3204, DB6891, PM4385R, DB5761, DB4811, DB4718, DB3231, DB2786, DB4793, DB2322, DB6522, DB4820, DB2216, DB6558, DB4113, DB5168, DB2544, DB6674, DB4263, DB4842, DB6369, DB6900, DB4828, DB4418, DB5204, DB5282, DB4286, DB5569, DB5626, FS1472, FS1473, FS1230, FS1234, DB2702, DB4367, DB6655, DB6920, DB4365, DB2219, FT1004, DB6156, DB6961, DB2421, DB5244, DB2530, DB2844, DB4890, DB5146, DB5443, DB6011, DB5940, DB6628, DB3318, DB2417, MD1748, DB6315, DB4134, FS1320, DB3307, DB4304, MD2027, DB4152, MD1851, FS1280, DB2152, DB6243, DB4680, FS1004, FS1094, FS1001, DB6570, DB6391, DB6393, DB3004, DB4706, DB4248, DB6392, DB4260, DB6573, DB6571, DB2840, DB6584, DB2974, DB6634, DB4267, DB4440, DB2548, DB4449, DB6491, DB6903, DB4892, DB5529, DB2925, DB6595, DB5538, DB4271, DB6936, DB4987, DB2337, DB3389, DB3340, DF1540, DB2332, DB7013, DB4492, FS1178, FS1519, DB4565, DB4589, DB4028, DB6430, DB3076, DB6258, MD1730, MD1810, DB4586, DB5340, DB6499, DB5347A, DB5398, DB6603, MD2086, DB6113, DB2884, DB4733, DB4739, DB2804, DB4631, DB2276, DB4506, DB3024, DB6123, DB6590, DB4557, DB6281, 94707, DB6426, DB6657, DB6933, DB6658, DB4936, DB6324, DB2561, DB5865, DB5163, DB5005, DB6745, DB5200, DB5878, DB6709, DB4869, DB6058, DB6646, DB6645, DB6843, DB5094, DB4917, DB6845, DB6863, DB7074, DB7003, DB7071, DB7004, DB6994, DB7041, DB7133, DB7132, DB7167, DB6755, DB7187, DB7144, DB7142, DB6451, DB6689, DB7199, DB7182, DB7203, DB7136, DB5880, DB6896, DB6464, DB6679, FS1426, MD1634, DB1679, DB7050, DB6342, DB6872, DB2657, DB6576, DB6719, DB6938, DB4377, DB7000, DB6733, FS1400, DB2556, MD1750, DB6237, DB5602, DB7007, DB7008, DB6883, DF1563, DB6950, DB6559, DB6951, DF1562, DB6918, DB5858, DB5350, DB6041, DB4998, DB6484, DB6505, DB5363, DB6792, DB7212, DB5381, DB5422, DB5682, DB5653, DB5429, DB5784, FS1494, DB2516, DB4662, DB4665, MD1793, MD1794, DB4763, DB6809, MD1916, DB5905, MD1610, MD1840, DB2160, DB7178, DB6302, DB6165, MD1925, MD2056, MD2122, DB5596, DB5919, DB5861, DB5862, DB5813, DB5937, DB5089, DB6034, DB2403, MD1619, DB7157, DB2453, DB2424, DB5215, DB1059, DB2238, DB4020, DB5740, DB5065, DB6858, DB5955, DB2244, DB5021, DB3086, DB4776, 97R4YC2, DB6296, DB5328, DB2245, DB2483, DB5329, DB2946, DB2945, DB5491, DB4348, DB5319, DB4299, DB4484, MD2033, DB3062, DB3279, DB3349, DB4149, DB 5844, DB 5845, DB5847, DB 5997, DB 5846, DB5888, DB5683, DB4805, DB6802, DF1547, DB6218, DB6685, RC1164, DB2212, DB3212, DB4868, DB4891, DB4478, DB4742, DB5096, DB4855, DB6262, DB5668, DB2384, DB6024, DB6071, DB7101, DB7098, DB7100, DB6018, DB6036, DB2939, DB2967, DB5286, DB2146, FS1073, DB7120, DB5522, DB2977, DB6096, DB6483, DB6604, DB6640, DB6750, DB6670, DB6814, DB6815, DB7099, DB6990, DB7122, DB7110, DB6736, DB7139, DB7140, DB7190, DB7180, DB7191, DB7194, DB7216, DB7204, DB7205, DB7197, DB7173, DB2312, DB6597, DB5077, DB3291, DB4538, DB6155, DB6485, DB6486, DB6487, DB6488, DB7062, DB7185, DB4344, DB4453, DB4952, MD1771, MD1877, DB4138, DB6142, DB6477, MD1847, FS1470, FS1476, DB5084, FS1244, MD2047, DB5302, DB7030, DB2170, DB4816, DB5620, DB5169, DB5507, DB5737, DB5202, DB6811, DB7034, DB2220, DB5525, DB2221, DB6715, DB6708, DB6734, DB6781, DB2588, DB6780, DB7054, DB6268, DB2204, DB5696, DB6403, DB2737, DB5643, DB6717, DB2660, DB6591, DB6911, DB2633, DB5743, DB6852, DB2357, DB2758, DF1552, DB6790, TBD1234, DB6786, DB6323, DB6996, DB6941, DB6850, DB6907, DB6980, DB6952, DB5449, DB5375, DB5373, DB7076, DB4234, DB5608, DB5407, DB5652, DB5430, DB5512, DB4550, DB5594, DB7097, DB6213, DB5550, MD1832, DB2493, DB5083, MD1917, DB5734, DB7175, DB5911, DB5756, DB7176, DB7179, DB5800, DB5914, MD1611, DB2705, DB2377, MD1615, DB2378, DB6032, DB6054, DB6861, DB6494, DB4055, DB2845, DB6357, DB4083, DB4225, DB6121, DB4635, DB4078, DB6383, DB6671, DB6381, DB2819, DB3154, FS1011, DB2966, FS1193, DB6532, DB2818, DB6291, DB6283, MD1791, DB6617, DB6457, DB3124, DB4835, DB6169, DB4682, DB4596, DB6212, DB4649, DB4366, DB7096, DB6929, DB6978, DB6913, DB6319, FS1485, FS1341, DB2178, DB2619, FS1270, DB6240, MD1690, DB6317, DB6239, DB6300, DB4872, DB4441, DB2998, DB6581, DB6540, DB4451, DB6635, DB6699, DB2335, FS1461, DB6160, FS1204, DB5325, DB6161, FS1520, DB4206, DB4024, DB4765, FS1419, DF1596, MD1624, DB4619, DB6242, DB6496, DB4321, DB6331, DB6241, DB6667, DB4759, DB4322, DB4326, DB4752, DB4338, DB6339, DB3054, DB6989, DB4594, DB4938, DB4939, DB7022, DB7023, DB5177, DB5232, DB5205, DB5242, DB5274, DB7040, DB6905, DB2163, DB6065, DB6993, DB2620,

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD confirmed that 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.