BACTEC FX instruments recalled after service credentials accessed by unauthorized actor
Becton Dickinson is recalling 177 BD BACTEC Blood Culture System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states unauthorized access may affect the integrity and availability of a diagnostic system and its data, with no injuries reported.
Plain-English summary
The BD BACTEC Blood Culture System is being recalled, covering the BD BACTEC FX Instrument Top (catalog number 44138509), the remanufactured Instrument Top BACTEC FX (441676) and the BACTEC 9240 System (445569).
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until those 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.
The recall covers 177 units, distributed worldwide including nationwide in the United States, Guam and Puerto Rico, and to Algeria, Argentina, Armenia and Australia among other countries. The FDA has classified the action as Class II.
Laboratories operating affected serial numbers should follow BD's instructions.
The recalled product
- 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…
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 177
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 6 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- SevereBD Phoenix Panel NMIC-306 Recalled for Quality Control Failures
FDA (Devices) · 2026-10-21
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
Same hazard · cybersecurity
See all →- ModerateiM3s series vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateiX series patient monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateFetal and maternal monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateiM8 series patient monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
- ModerateM3 vital signs monitors recalled over potential cybersecurity issues
FDA (Devices) · 2026-01-28
Similar recalls
- HighBD BACTEC FX Instrument Top credential compromise enables unauthorized access risk
FDA (Devices) · 2024-12-11
- HighMedical Device Breach: BACTEC 9240 System Faces Unauthorized Access Risk
FDA (Devices) · 2024-12-11
- ModerateBD BACTEC FX40 Product Service Credentials Accessed by Unauthorized Actor
FDA (Devices) · 2024-12-11
- HighBACTEC 9120 System Recalled Due to Compromised Service Credentials
FDA (Devices) · 2024-12-11
- HighBD COR GX Instrument recalled due to compromised service credentials
FDA (Devices) · 2024-12-11
- ModerateBD COR MX Instruments Affected by Unauthorized Service Credentials Access
FDA (Devices) · 2024-12-11