Z-0236-2026Class II

Becton Dickinson & Co.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2025-10-29

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

Firm state

Product quantity

177 units

Initiated by

Voluntary: Firm initiated

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 description

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.

Code / lot info

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.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →