CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report

BD Bactec Blood Culture System, labeled as the following recalled

Becton Dickinson is recalling BD Bactec Blood Culture System, labeled as the following: Bactec 9120 System, distributed nationwide in the US. The recall was initiated on 23 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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).

Quantity recalled1,086 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0237-2026
FDA event ID: 97479
Recalling firm: Becton Dickinson, Sparks, MD
Classification: Class II
Status: Ongoing
Recall initiated: 23 Sep 2025
FDA classified: 23 Oct 2025
Reported: 29 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Sep 2025	Recall initiated by company
23 Oct 2025	Classified by FDA	+30 days
29 Oct 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

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).

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 97479

This product is part of a recall event; the main page for the event is BD EpiCenter Microbiology Data Management System recalled.

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025	CLASS II	BD EpiCenter Microbiology Data Management System recalled	Becton Dickinson	Other	Nationwide
29 Oct 2025	CLASS II	BD Veritor Connect recalled by Becton Dickinson &	Becton Dickinson	Device Malfunction	Nationwide
29 Oct 2025	CLASS II	BD Bactec Blood Culture System, labeled as the following recalled	Becton Dickinson	Packaging Defects	Nationwide
29 Oct 2025	CLASS II	BD MAX System, for in vitro diagnostic (IVD) use recalled	Becton Dickinson	Other	Nationwide
29 Oct 2025	CLASS II	BD Phoenix M50 Instrument, labeled as the following recalled	Becton Dickinson	Other	Nationwide

More recalls from Becton Dickinson

All 364

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &	Becton Dickinson	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &	Becton Dickinson	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Quincke Needle recalled by Becton Dickinson &	Becton Dickinson	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &	Becton Dickinson	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle, BD¿Quincke Needle recalled	Becton Dickinson	Processing Deviation	Nationwide

Other Other Medical Devices recalls

All 13,884

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Palacos R pro recalled by Heraeus Medical GmbH (Dental	Heraeus Medical GmbH (Dental Division)	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide