Becton, Dickinson & Co.
FDA adverse event reports naming Becton, Dickinson & Co. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BECTON, DICKINSON & CO..
- Total reports
- 5,485
- Deaths
- 5
- Injuries
- 162
- Malfunctions
- 5,312
Reports per year
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA4,292
- Tubes, Vacuum Sample, With AnticoagulantGIM282
- Culture Media, Non-Propagating TransportJSM172
- Reagents, 2019-Novel Coronavirus Nucleic AcidQJR143
- Container, Specimen Mailer And Storage, SterileKDT113
- Stains, MicrobiologicJTS106
- Real Time Nucleic Acid Amplification SystemOOI75
- Lymphocyte Separation MediumJCF48
- Coronavirus Antigen Detection Test System.QKP40
- Container, Specimen, SterileFMH39
Recent recalls
- 2026-04-29Open, ClassifiedUnder Investigation by firm
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
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.
- 2026-04-29Open, ClassifiedUnder Investigation by firm
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
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.
- 2025-11-07Open, ClassifiedUnder Investigation by firm
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
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.
- 2025-10-23Open, ClassifiedSoftware design
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
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.
- 2025-10-23Open, ClassifiedSoftware design
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.
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.
- 2025-10-23Open, ClassifiedSoftware design
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
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.
- 2025-10-23Open, ClassifiedSoftware design
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
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.
- 2025-10-23Open, ClassifiedSoftware design
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
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.
- 2025-10-23Open, ClassifiedSoftware design
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
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.
- 2025-07-23Open, ClassifiedUnder Investigation by firm
BD COR System Software. Model Number: 444829.
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
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