Becton Dickinson & Co. — BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 23, 2025
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.
What's affected?
- Product
- BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
- Lot code
- 1. Catalog Number: 44138509; UDI/DI: 00382904413859; Serial Numbers: FT5675, FT5497, FT4948, FT5781, FT5120, FT3993, FT7779, FT3387, FT1993, FT5019, FT9109, FT8412, FT7176, FT7344, FT4282, FT7400, FT6093, FT0962, FT2780, FT0795, FT0794, FT2799, FT5924, FT5279, FT5286, FT0572, FT4931, FT7289, FT9801, FT2652, FT5232, FT1348, FT8083, FT0640, FT7159, FT7034, FT8410, FT0098, FT2650, FT6203, FT3480, FT4917, FT3031, FT3033, FT4902, FT7189. 2. Catalog Number: 441676; UDI/DI: 00382904416768; Serial Numbers: FT7439A, FT7201A, FT5679, FT0599, FT0598, FT0644, FT0600, FT5025, FT2845, FT0525, FT0715, FT4439, FT0330, FT2313, FT3020, FT3022, FT0745, FT5090, FT4340, FT6225, FT4977, FT0571, FT0570, FT0498, FT5248, FT5270, FT3537, FT4448, FT3538, FT3486, FT0340, FT1517, FT5590, FT3030, FT4800, FT1774, FT2263, FT5014, FT5013, FT7184A. 3. Catalog Number: 445569; UDI/DI: 00382904455699; Serial Numbers: DB4372, DB6043, DB5030, DB5825, DB2835, DB3251, DB3245, DB3145, DB5876, DB5906, DB3143, DB3204, DB6891, PM4385R, DB4718, DB3231, DB2786, DB6628, DB6393, DB6936, DB4987, DB5347A, DB6123, DB6281, DB6933, DB6451, DB5602, DB5858, DB4763, DB6302, DB6165, DB5596, DB5089, DB7157, DB5021, DB3086, DB4776, DB6296, DB5328, DB2245, DB2483, DB5329, DB2946, DB2945, DB4348, DB5319, DB4299, DB4484, MD2033, DB3062, RC1164, DB6323, DB4550, DB6213, DB5083, DB6383, DB6381, DB6457, DB6169, DB6212, DB6929, DB6978, DB6913, DB6540, DB6699, DB6989. 4. Catalog Number: 44229609; UDI/DI: 00382904422967; Serial Numbers: FF1979, FF0713, FF0410, FF1561, FF2832, FF4395, FF1500, FF0697, FF0933, FF1499, FF1025, FF5511, FF0027, FF1118, FF3195, FF0115, FF5979, FF6535, FF0391, FF3284, FF0772, FF0570, FF0638, FF1599, FF1271.
Additional details
1. Catalog Number: 44138509; UDI/DI: 00382904413859; Serial Numbers: FT5675, FT5497, FT4948, FT5781, FT5120, FT3993, FT7779, FT3387, FT1993, FT5019, FT9109, FT8412, FT7176, FT7344, FT4282, FT7400, FT6093, FT0962, FT2780, FT0795, FT0794, FT2799, FT5924, FT5279, FT5286, FT0572, FT4931, FT7289, FT9801, FT2652, FT5232, FT1348, FT8083, FT0640, FT7159, FT7034, FT8410, FT0098, FT2650, FT6203, FT3480, FT4917, FT3031, FT3033, FT4902, FT7189. 2. Catalog Number: 441676; UDI/DI: 00382904416768; Serial Numbers: FT7439A, FT7201A, FT5679, FT0599, FT0598, FT0644, FT0600, FT5025, FT2845, FT0525, FT0715, FT4439, FT0330, FT2313, FT3020, FT3022, FT0745, FT5090, FT4340, FT6225, FT4977, FT0571, FT0570, FT0498, FT5248, FT5270, FT3537, FT4448, FT3538, FT3486, FT0340, FT1517, FT5590, FT3030, FT4800, FT1774, FT2263, FT5014, FT5013, FT7184A. 3. Catalog Number: 445569; UDI/DI: 00382904455699; Serial Numbers: DB4372, DB6043, DB5030, DB5825, DB2835, DB3251, DB3245, DB3145, DB5876, DB5906, DB3143, DB3204, DB6891, PM4385R, DB4718, DB3231, DB2786, DB6628, DB6393, DB6936, DB4987, DB5347A, DB6123, DB6281, DB6933, DB6451, DB5602, DB5858, DB4763, DB6302, DB6165, DB5596, DB5089, DB7157, DB5021, DB3086, DB4776, DB6296, DB5328, DB2245, DB2483, DB5329, DB2946, DB2945, DB4348, DB5319, DB4299, DB4484, MD2033, DB3062, RC1164, DB6323, DB4550, DB6213, DB5083, DB6383, DB6381, DB6457, DB6169, DB6212, DB6929, DB6978, DB6913, DB6540, DB6699, DB6989. 4. Catalog Number: 44229609; UDI/DI: 00382904422967; Serial Numbers: FF1979, FF0713, FF0410, FF1561, FF2832, FF4395, FF1500, FF0697, FF0933, FF1499, FF1025, FF5511, FF0027, FF1118, FF3195, FF0115, FF5979, FF6535, FF0391, FF3284, FF0772, FF0570, FF0638, FF1599, FF1271.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 177 units.
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