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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Becton Dickinson & Co.: Laboratory Informatics and Diagnostic Systems Recalled for Cybersecurity Risk

Agency Publication Date: December 3, 2024
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Summary

Becton Dickinson & Co. (BD) is recalling approximately 42,991 units of laboratory software and diagnostic hardware systems after confirming that technical support login credentials were accessed by an unauthorized individual. The recall includes several major diagnostic platforms, including the BD EpiCenter, BD MAX, BD Synapsys, BD Phoenix M50, and BACTEC (FX, FX40, 9120, 9240) systems. These products are primarily used in medical and research laboratories for managing diagnostic data and testing patient samples for infections. While there have been no reports of patient harm or exploited vulnerabilities in clinical environments, BD is taking steps to reset and update all affected credentials to prevent unauthorized access. Owners of these systems should continue to use the products but must contact the manufacturer to ensure their specific software and hardware receives necessary security patches.

Risk

Login codes used by BD’s technical support teams to maintain and repair equipment were stolen by an unauthorized person. Because these codes allow access to the systems, an intruder could potentially view private patient data or alter system settings, which could affect the accuracy or availability of important medical test results.

What You Should Do

  1. Identify your laboratory equipment by checking the brand and catalog numbers to see if you have affected models of BD EpiCenter, BD COR, BD MAX, BD Synapsys, BD Phoenix M50, or BACTEC (FX, FX40, 9120, 9240) systems.
  2. For hardware systems, cross-reference the serial numbers on your instruments with the extensive lists provided in the recall documentation, which include specific codes such as the CT-series for BD MAX and FT-series for BACTEC FX.
  3. For software-only systems like BD EpiCenter (Catalog Nos. 441007 and 440981), identify the version and catalog number within the software application or on your installation records.
  4. Contact BD technical support at your local regional office or visit the BD Cybersecurity portal to coordinate a reset of the compromised service credentials for your specific instruments.
  5. Follow any specific cybersecurity guidance or software updates provided by the manufacturer in the notification letter sent in October 2024 to ensure your system remains secure.
  6. Contact your healthcare provider or laboratory director if you have concerns regarding the integrity of diagnostic results generated by these systems.
  7. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this medical device security recall.

Your Remedy Options

📋Other Action

Security reset and update of technical support credentials.

How to: Contact BD technical support to coordinate a service reset and update of login credentials for your diagnostic instruments and software.

Affected Products

Product: BD EpiCenter Single User Software
Model / REF:
441007
UPC Codes:
00382904410070
Lot Numbers:
Not serialized
Product: BD EpiCenter Data Management System
Model / REF:
440887
UPC Codes:
0382904408879
Lot Numbers (319):
6GF3TD2
2MJHML1
697JFF3
HSB9WV1
YL00QYF9
GMWYLN2
1TR5JL2
GD6XCP2
HGKCXQ2
FH62RP2
GDBZCP2
GD92DP2
CPQ77X2
H3JQ3Y2
20HJ4Z2
5D2BSZ2
DXMWG13
DXP1H13
DXQTG13
GL2MZB3
15XTT52
3WZ7S52
B1HJSD2
HDQBND2
GL2RZB3
6977NF3
697CNF3
6P9P704
1TT5JL2
GMVYLN2
GD9ZCP2
GDC0DP2
GDBYCP2
1TS5JL2
1TT4JL2
FH42RP2
5LVX7M2
5LVY7M2
FH51RP2
FH43RP2
GD6ZCP2
1TV2JL2
5LWV7M2
5LWY7M2
GD70DP2
GD91DP2
5LWZ7M2
5D27SZ2
5D33SZ2
4Q40H03
Product: BD EpiCenter Data Management System, Multi User Software
Model / REF:
440981
UPC Codes:
00382904409814
Lot Numbers:
Various serials (Matches 440887 list)
Product: BD COR PX Instrument
Model / REF:
443988
UPC Codes:
00382904439880
Lot Numbers (66):
CRP0007
CRP0025
CRP0045
CRP0064
CRP0058
CRP0060
CRP0055
CRP0040
CRP0056
CRP0038
CRP0057
CRP0062
CRP0046
CRP0031
CRP0068
CRP0053
CRP0034
CRP0041
CRP0021
CRP0054
CRP0004
CRP0001
CRP0008
CRP0009
CRP0012
CRP0013
CRP0014
CRP0017
CRP0018
CRP0048
CRP0051
CRP0027
CRP0042
CRP0069
CRP0074
CRP0032
CRP0075
CRP0077
CRP0080
CRP0079
CRP0024
CRP0011
CRP0010
CRP0016
CRP0019
CRP0028
CRP0061
CRP0063
CRP0033
CRP0044
Product: BD COR MX Instrument
Model / REF:
443989
UPC Codes:
00382904439897
Lot Numbers:
CRM0001
CRM0105
CRM0114
CRM0003
CRM0113
CRM0109
CRM0010
CRM0106
CRM0108
CRM0116
CRM0117
CRM0119
CRM0004
CRM0107
CRM0112
CRM0111
CRM0115
CRM0118
Product: BD COR GX Instrument
Model / REF:
443990
UPC Codes:
00382904439903
Lot Numbers (70):
CRG0023
CRG0041
CRG0115
CRG0040
CRG0106
CRG0110
CRG0112
CRG0109
CRG0047
CRG0120
CRG0039
CRG0113
CRG0035
CRG0037
CRG0036
VGT0009
CRG0020
CRG0002
VGX0004
CRG0007
CRG0008
CRG0104
CRG0018
CRG0019
CRG0045
CRG0029
CRG0028
CRG0030
CRG0201
CRG0203
CRG0021
CRG0004
CRG0005
CRG0006
CRG0009
CRG0010
CRG0012
CRG0011
CRG0013
CRG0014
CRG0025
CRG0015
CRG0016
CRG0017
CRG0026
CRG0027
CRG0107
CRG0101
CRG0105
CRG0108
Product: BD MAX System / Instrument
Model / REF:
441916
UPC Codes:
00382904419165
Lot Numbers:
CT-series, CM-series, MX-series (e.g., CT1777, CM0122, MX0057)
Product: BD Synapsys Informatics Solution
Model / REF:
444150
UPC Codes:
00382904441500
Lot Numbers (56):
JRPN215003AB
BTDN93800189
JRPN215003VS
BTDN938000WP
BTDN938000XZ
BTDN93600B4R
BTDN0160058Z
BTDN939007WP
BTDN938000Z3
BTDN940003G5
BTDN932008FF
BTDN94000424
BTDN940003AV
BTDN938000WY
JRPN215003UA
JRPN215003M8
BTDN01800017
JRPN215003V7
BTDN934008WP
JRPN215003M4
BTDN939007Z9
JRPN2150038H
BTDN9380016F
BTDN938000WU
BTDN938001FL
JRPN215004L1
BTDN93600B0K
JRPN215003E8
BTDN934008S2
BTDN93600B3E
JRPN215004R7
JRPN215003CL
BTDN93600B5G
BTDN9200040Q
JRPN215004J9
JRPN21500418
BTDN934008UD
BTDN920003X8
JRPN215003JT
BTDN0180005Q
JRPN215003CZ
BTDN018000DT
JRPN215003CR
BTDN934008T2
JRPN215003M1
JRPN215003HR
JRPN215003TN
BTDN934008CE
BTDN932009P7
JRPN215003JG
Product: BD Phoenix M50 Automated Microbiology System
Model / REF:
443624
UPC Codes:
00382904436247
Lot Numbers:
PF-series (e.g., PF4176, PF4182, PF2302)
Product: BD BACTEC FX, Instrument Top
Model / REF:
441385
UPC Codes:
00382904413859
Lot Numbers:
FT-series, T-series (e.g., FT9750, T10574)
Product: BD BACTEC FX40 Instrument
Model / REF:
442296
UPC Codes:
00382904422967
Lot Numbers:
FF-series (e.g., FF7385, FF7425, FF2727)
Product: BACTEC 9120 System
Model / REF:
445570
UPC Codes:
00382904455705
Lot Numbers:
UB-series (e.g., UB4523, UB3416, UB3975)
Product: BACTEC 9240 System
Model / REF:
445475
UPC Codes:
00382904454753
Lot Numbers:
DB-series, MD-series, FS-series (e.g., DB5631, MD1710, FS1472)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95636
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Authorized medical diagnostic equipment distributors; BD direct sales
Manufactured In: United States
Units Affected: 13 products (Software; 7,974 units (2,517 US, 5,457 OUS); 7,974 units (2,517 US, 5,457 OUS); 66 units (18 US, 48 OUS); 18 units (12 US, 6 OUS); 70 units (7 US, 63 OUS); 2,537 units (876 US, 1,661 OUS); 56 units (OUS only); 4,411 units (567 US, 3,844 OUS); 10,129 units (2,836 US, 7,293 OUS); 8,085 units (838 US, 7,247 OUS); 1,087 units (136 US, 951 OUS); 584 units (313 US, 271 OUS))
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.