Becton, Dickinson & Co.
7 LOVETON CIR., SPARKS, MD, US
Registered product codes
102 product codes
Recent MDR events
46,694 on file
- BD BACTEC¿ MGIT¿ 960 InstrumentJul 31, 2026Malfunction1119779-2026-01375
- BD BACTEC¿ MGIT¿ 960 InstrumentJul 31, 2026Malfunction1119779-2026-01376
- Panel Phoenix NMIC/ID-483Jul 31, 2026Malfunction1119779-2026-01377
- BD Phoenix¿ M50 Automated Microbiology SystemJul 31, 2026Malfunction1119779-2026-01374
- BD Difco¿ Tryptic Soy BrothJul 31, 2026Malfunction1119779-2026-01380
- BD COR GX INSTRUMENTJul 31, 2026Malfunction1119779-2026-01381
- BD Phoenix¿ M50 Automated Microbiology SystemJul 31, 2026Malfunction1119779-2026-01379
- BD Phoenix¿ M50 Automated Microbiology SystemJul 31, 2026Malfunction1119779-2026-01378
- BD Vacutainer® SST¿ Blood Collection TubesJul 30, 2026Malfunction1024879-2026-01362
- BD Vacutainer® SST¿ Blood Collection TubesJul 30, 2026Malfunction1024879-2026-01363
Recalls
248 on file
- Open, ClassifiedApr 29, 2026
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
View FDA record ↗ - Open, ClassifiedApr 29, 2026
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
View FDA record ↗ - Open, ClassifiedNov 7, 2025
The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
View FDA record ↗ - Open, ClassifiedOct 23, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 23, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 23, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 23, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 23, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 23, 2025
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.
View FDA record ↗ - Open, ClassifiedJul 23, 2025
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
View FDA record ↗
Compliance history
Matched by FEI 1119779.
FDA inspections
2 on file
- No Action Indicated (NAI)Aug 1, 2025
Compliance: Devices
- No Action Indicated (NAI)Aug 1, 2025
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.