—#215729

Product

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.

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K922475
Affected 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).

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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.

Timeline

Recall initiated: 2025-09-23
Posted by FDA: 2025-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.