BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
- Company
- Becton Dickinson & Co.
- Recall Initiated
- September 23, 2025
- Posted
- October 23, 2025
- Recall Number
- Z-0237-2026
- Quantity
- 1,086 units
- Firm Location
- Sparks, MD
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.
Distribution
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.
Lot / Code Info
1. Catalog Number, (Serial Numbers): 445570, UDI/DI: 00382904455705 (UB4523, UB3416, UB3975, UB3871A, UB3753, UB4823, DB2572, UB4642, UB3414, UM1431, UB3731, UB1470, UB5555, UM1395, UB4212, UB3555, UB4159, UB4778, UB3805, UB1648, UB4562, UB4174, UB4325, UB1801, UB5086, UB1990, UB3103, UB4274, UB4360, UB1611, UB4535, UB4542, UB4596, UB3338, UB4688, UB3480, UB4928, UB4929, UB1439, UB1583, UB5178, UB3122, UB3335, UB3229, UB4005, UB1682, UB3541, UB3193, UB4184, UB1778, UB4405, UB3413, UB4271, UB4715, UB3210, UB4110, UB4112, UB3499, UB5405, UB5389, UB5442, UB5362, UB4995, UB1812, UB4427, UB4253, UB1708, UB3273, UM1273, UB4959, US1103, UB3383, UM1283, UM1269, UB5663, UB4384, UB5569, UB5470, UB5594, UB4185, UB5679, UB5527, UB5361, UB5579, UB4280, UB5535, UB4221, UB5596, UB5576, UB5588, UB5496, UB5610, UB3242, UB5537, UB5553, UB5565, UB5451, UB5505, UB5492, UB5507, UB5526, UB5691, UB5693, UB5694, UB5456, UB5609, UB5534, UB5631, UB5469, UB5541, UB3647, UB4048, UB4177, UB5415, UB5080, UB5529, UB5587, UB3398, UB5584, UB5414, UB5444, UB5474, UB5495, UB5523, UB5503, UB5431, UB3814, UB5550, UB5559, UB4661, UB5073, UB4776, UB5074, UB5059, UB5380, UB3491, UB4922, UB1862, UB4881, UB5093, UB2082, UB5079, UB4711, UB5101, UB5092, UB5108, UB5038, UB4704, UB4953, UB5026, UB5017, UB5110, UB5041, UB5078, UB5118, UB5598, UB5111, UB5153, UB3634, UB5149, UB5005, UB5152, UB5164, UB5129, UB5050, UB5151, UB5165, UB5158, UB9654, UB5135, UB5207, UB5195, UB5171, UB5205, UB5117, UB5229, UB5241, UB5234, UB5230, UB5140, UB5167, UB5222, UB5255, UB5063, UB5199, UB5224, UB5265, UB5136, UB5283, UB5285, UB5304, UB5060, UB5289, UB5246, UB4369, UB5309, UB5302, UB5299, UB3148, UB5235, UM1331, UB1653, UB5420, UB3654, UB5329, UB4315, UB3026, UB3336, UB1501, UB3767, UB4334, UB5373, UB5791, UB5156, UB4560, UB5300, UB4519, UB5463, UB4340, UB4244, UB5472, UB3703, UB5296, UB5457, UB5317, UB3704, UB5465, UB5393, UB4356, UB3700, UB5279, UB5130, UB5297, UB4600, UB5471, UB5479, UB4545, UB4466, UB5428, UB5488, UB3851, UB5308, UB5253, UB3483, UB5298, UB4602, UB4471, UB5339, UB3812, UB4518, UB5324, UB5381, UB4504, UB5364, UB3785, UB5397, UB4539, UB4540, UB4420, UB5358, UB5433, UB3919, UB5434, UB4481, UB5425, UB5502, UB4346, UB4507, UB5371, UB5141, UB5379, UB3320, UB4610, UB5244, UB4554, UB4567, UB4620, UB4057, UB4424, UB4634, UB5218, UB4614, UB3894, UB5316, UB5483, UB5303, UB3863, UB5374, UB4115, UB5375, UB4583, UB4114, UB4392, UB5481, UB5353, UB4581, UB4088, UB4751, UB5365, UB4666, UB1049, UB3082, UB5466, UB5360, UB1734, UB5454, UB3062, UB2013, UB1689, UB3264, UB4571, UB5412, UB4684, UM1406, UB5581, UB1555, UB5319, UB4485, UB5589, UB4653, UB5406, UB4705, UB5396, UB1746, UB4706, UB5290, UB5432, UB4572, UB4117, UB4745, UB5543, UB4175, UB5514, UB5604, UB4730, UB3907, UB5372, UB4719, UB4681, UB4162, UB5245, UB4768, UB5388, UB4483, UB4718, UB5119, UB4139, UB5301, UB4232, UB5367, UB4723, UB5125, UB5382, UB5142, UB4747, UB3489, UB4641, UB4618, UB5061, UB4633, UB4817, UB4638, UB5418, UB4226, UB5417, UB4835, UB4643, UB4809, UB5262, UB5221, UB5422, UB5551, UB5261, UB4834, UB4756, UB4838, UB4812, UB4766, UB4810, UB4826, UB5621, UB4781, UB4861, UB4856, UB4859, UB4876, UB4854, UB5620, UB5540, UB4860, UB5538, UB4765, UB5560, UB5506, UB4755, UB5530, UB5585, UB5574, UB4902, UB4888, UB4886, UB3237, UB4870, UB4914, UB4880, UB4901, UB4906, UB4935, UB4932, UB4805, UB4917, UB4934, UB4918, UB4955, UB4905, UB4956, UB4944, UB4963, UB4916, UB4964, UB4969, UB4806, UB4979, UB4983, UB4135, UB5030, UB5013, UB4994, UB5004, UB5034, UB5020, UB4374, UB4478, UB4612, UB4651, UB4738, UB3718, UB3811, UB4463, UB3865, UB3868, UB3877, UB3878, UB3911, UB3914, UB3915, UB5636, UB5638, UB5640, UB5642, UB5641, UB3940, UB5646, UB5650, UB5654, UB1248, UB9256, UB5347, UB5345, UM1239, UB1792, UB0031, UB3709, UB4740, UB4732, UB3479, UB1793, UB1750, UB1057, UB1609, UB3853, UB3205, UB3448, UB3539, UB3779, UM1180, UM1201, UB0097, UM1345, UM2069, UB1048, UB3696, UB5102, UB5209, UB5607, UB3655, UB5561, UB5517, UB4461, UB5180, UB3948.UB3852, UB3984, UB3265, UB5036, UB4930, UB1671, UM1403, UB3952, UB5668, UB5015, UB4899, UB4129, UB4093, UB4894, UB4981, UB4147, UB5133, US1048, UB4260, UB4587, UB3275, UB4565, UB5268, UB5392, UB5453, UB4986, UB4475, UB5387, UB5196, UB5042, UB5443, UB5210, UB3813, UB3658, UB5223, UB4637, UB3561, UB5459, UB4201, UB4703, UB3013, UB4052, UB1977, UB5132, UB5064, UB5175, UB5247, UB4419, UB4862, UB4866, UB5557, NB3896, UB5292, UB4412, UB3553, UB4700, UB1672, UB4489, UB4491, UB5404, UB5002, UB4113, UB4487, UB3876, UB4259, UB1657, UB3170, UB1892, UB1925, UB4658, UB1716, UB5105, UB3010, UB4379, UB5021, UB3259, UB1891, UB1668, UB1878, UB5344, UB5342, UB5512, UB5441, UB5137, UB5052, UB3721, UB2051, UB5286, UB3396, UB4181, UB3950, UB5024, UB4394, UB5661, UB5662, UB5511, UB5563, UB5675, UB1553, UB5623, UB5508, UB5676, UB5608, UB5685, UB5447, UB5546, UB5341, UB5409, UB5438, UB5318, UB5577, UB5413, UB5625, UB5522, UB5545, UB5570, UB5627, UB5595, UB5485, UB5352, UB5462, UB5572, UB5612, UB3745, UB5593, UB5548, UB5619, UB5700, UB5586, UB5567, UB5582, UB5583, UB5439, UB5613, UB5578, UB5532, UB5562, UB5599, UB5571, UB5615, UB5558, UB5519, UB5590, UB4043, UB4220, UB5084, UB5057, UB5043, UB5053, UB5076, UB5087, UB5071, UB5099, UB5068, UB5077, UB5098, UB5066, UB5029, UB5070, UB5094, UB5045, UB5095, UB5122, UB5085, UB5022, UB4977, UB5104, UB5116, UB5124, UB5072, UB5120, UB5138, UB5145, UB5147, UB5155, UB5157, UB5169, UB5170, UB8041, UB5168, UB5146, UB5143, UB5096, UB4731, UB4904, UB5160, UB5106, UB5201, UB5197, UB5618, UB5154, UB5225, UB5243, UB5206, UB5212, UB4873, UB4631, UB5254, UB5267, UB5184, UB5211, UB5203, UB5194, UB5240, UB5219, UB5677, UB5277, UB5148, UB5242, UB5294, UB5239, UB5275, UB5131, UB5305, UB5295, UB5326, UB5573, UB5282, UB5368, UB3055, UB5385, UB3570, UB5270, UB5314, UB3042, UB5323, UB3493, UB5461, UB5429, UB4231, UB3636, UB3706, UB1934, UB3424, UB4245, UB5313, UB5359, UB5284, UB5416, UB5458, UB5260, UB5467, UB4333, UB4354, UB5435, UB4339, UB4872, UB5306, UB4342, UB5272, UB3768, UB5159, UB4355, UB5338, UB5202, UB4423, UB5516, UB5486, UB5327, UB5370, UB3800, UB4438, UB5320, UB5348, UB4205, UB3750, UB4505, UB5322, UB5307, UB5357, UB3771, UB5256, UB4410, UB4510, UB5331, UB5424, UB5489, UB4566, UB5123, UB4011, UB5408, UB4553, UB3350, UB4068, UB4486, UB4558, UB4070, UB5264, UB4083, UB5334, UB4503, UB4482, UB4498, UB5377, UB4555, UB5494, UB5177, UB5355, UB4648, UB4116, UB5500, UB4474, UB4680, UB5293, UB4720, UB5335, UB5291, UB5468, UB4773, UB5473, UB4102, UB5198, UB5455, UB5399, UB5259, UB4178, UB4685, UB4721, UB5386, UB5366, UB4105, UB4758, UB4775, UB4764, UB5491, UB5515, UB5448, UB4743, UB4759, UB5501, UB5394, UB5449, UB4464, UB5419, UB5346, UB4686, UB4163, UB5263, UB4225, UB5407, UB4763, UB5310, UB5340, UB5450, UB4767, UB5332, UB4237, UB5383, UB5333, UB4761, UB4782, UB4422, UB4871, UB5232, UB5351, UB4821, UB4671, UB5069, UB5597, UB4807, UB5547, UB4837, UB4804, UB5611, UB5464, UB5624, UB5436, UB5552, UB5549, UB4855, UB4878, UB4748, UB5518, UB5564, UB5440, UB4762, UB5498, UB4892, UB4462, UB5437, UB4885, UB4780, UB5112, UB4848, UB5065, UB5173, UB4779, UB4879, UB5533, UB4889, UB5524, UB4887, UB4852, UB4909, UB4882, UB4717, UB4948, UB4936, UB4939, UB4942, UB4853, UB4839, UB4744, UB4836, UB4891, UB4777, UB4954, UB2083, UB4884, UB4808, UB3132, UB4774, UB4965, UB4957, UB4403, UB4933, UB3680, UB4968, UB4984, UB4989, UB4679, UB4940, UB4769, UB2027, UB4198, UB4970, UB5037, UB5031, UB4982, UB5018, UB5014, UB4985, UB5044, UB4927, UB3432, UB4608, UB4632, UB4644, UB1983, UB4084, UB5602, UB5614, UB5622, UB5616, UB5634, UB3912, UB5630, UB3929, UB5645, UB5643, UB5649, UB5651, UB5653, UB5655, UB4064, UB2126, UB3304, UB3366, UB3481, UB4913, UM1179, UM1730, US1113, UB3440, UB4047, UB4261, UB4456, UB4425, UB4497, UB4820, UB4911, UB3452, UB1458, UB3482, UB6515, UB4173, UB4534, UB4662, UB1952, UM5032, UB4381, UB4363, UB4515, UB4692, UB4695, UB4365, UB4273, UB4603, UB4657, UB1629, UB4697, UB4582, UB1673, UB4303, UM1350, UB1697, UB4530, UB4490, UB4577, UB4598.UB4561, UB4604, UB4592, UB3677, UB3065, UB4296, UB4750, UB4771, UB3770, UB3992, UB3971, UB3964, UB4050, UB3976, UB4868, UB4059, UB4101, UB1622, UB4617, UB1519, UB3004, UB1813, UB4298, UB1912, UB4179, UB3286, UB3299, UB4209, UB4432, UB1915, UB4263, UB3310, UB4211, UB4270, UB2076, UB3023, UB3197, UB3411, UB3157, UB2026, UB2022, UB4319, UB3324, UB1893, UB3333, UB4429, UB1713, UB4233, UB3296, UB3272, UB3225, UB2078, UB3377, UB3236, UB3332, UB4446, UB3648, UB4707, UB3551, UB3513, UB4712, UB4401, UB3303, UB3317, UB4343, UB4945, UB5249, UB5010), 445702, UDI/DI: 00382904457020, (UB4002A, UB3795, UB4188, UB4006, UB1523, UB3123, UB4154B, UB3139, UB3191, UB3595, UB3409, US1125, UB4347, UB4351, UB3946A, UB4587A, UB3318, UB3007, UB1474, UB4285, UB4118, UB4670, UB4621, UB4301, UB3445). 2. Catalog Number: 44557008, UDI/DI: 00382904455705, serial numbers (UB4073, UB4358).
Root Cause
Software design
Action Taken
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. Consignees 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.