Becton Dickinson & Co
Cockeysville, MD, US
BECTON, DICKINSON & CO. appears in FDA device records in Cockeysville, MD. FDA records list 345 510(k) clearances between and , 29 PMA records and 18 registered establishments. As of , FDA records show 754 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
5 namesFDA records resolved to Becton Dickinson & Co carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Bd Diagnosticenforcement report, recall
- BD Opthalmic Systemsrecall
- Beaver Visitecenforcement report, recall
- Beaver-Visitec International, Ltdregistration, 510(k), PMA, enforcement report, recall
- Tripath Imaging, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 345FDA records hold 345 510(k) clearances for Becton Dickinson & Co between 2001 and 2026. The busiest year on record is 2005, with 35. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 4 |
| 2002 | 27 |
| 2003 | 26 |
| 2004 | 25 |
| 2005 | 35 |
| 2006 | 24 |
| 2007 | 11 |
| 2008 | 11 |
| 2009 | 9 |
| 2010 | 9 |
| 2011 | 7 |
| 2012 | 8 |
| 2013 | 21 |
| 2014 | 11 |
| 2015 | 10 |
| 2016 | 15 |
| 2017 | 11 |
| 2018 | 10 |
| 2019 | 6 |
| 2020 | 8 |
| 2021 | 7 |
| 2022 | 14 |
| 2023 | 13 |
| 2024 | 6 |
| 2025 | 12 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | JKA | Substantially Equivalent | |
| K252506 | BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | JKA | Substantially Equivalent | |
| K260184 | Onclarity™ Self-Collection Kit | SEP | Substantially Equivalent | |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes | JKA | Substantially Equivalent | |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe | NGT | Substantially Equivalent | |
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | PCI | Substantially Equivalent | |
| K250059 | BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) | ONB | Substantially Equivalent | |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | LON | Substantially Equivalent | |
| K251350 | BD Plastipak™ Syringe | FMF | Substantially Equivalent | |
| K243207 | BD Vacutainer® Eclipse™ Blood Collection Needle | JKA | Substantially Equivalent | |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | PHC | Substantially Equivalent | |
| K243872 | BD Veritor System for SARS-CoV-2 | QVF | Substantially Equivalent | |
| K250447 | BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | LON | Substantially Equivalent | |
| K240615 | Leos Laser and Endoscopy System | HQF | Substantially Equivalent | |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | JKA | Substantially Equivalent | |
| K250344 | BD Phoenix™ Automated Microbiology System | LON | Substantially Equivalent | |
| K243725 | BD Vaginal Panel | PQA | Substantially Equivalent | |
| K242320 | BD Vacutainer® One Use Holder | JKA | Substantially Equivalent | |
| K240455 | BD Vacutainer® Citrate Blood Collection Tubes | GIM | Substantially Equivalent | |
| K233986 | BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) | LON | Substantially Equivalent | |
| K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | JKA | Substantially Equivalent | |
| K231237 | BD Vacutainer® Fluoride Blood Collection Tubes | JKA | Substantially Equivalent | |
| K230855 | BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes | JKA | Substantially Equivalent | |
| K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube | JKA | Substantially Equivalent | |
| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | GIM | Substantially Equivalent | |
| K222563 | BD Kiestra IdentifA | QQV | Substantially Equivalent | |
| K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes | GIM | Substantially Equivalent | |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe | NGT | Substantially Equivalent | |
| K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes | JKA | Substantially Equivalent | |
| K230651 | BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) | JTN | Substantially Equivalent | |
| K222591 | BD BACTEC™ Plus Aerobic/F Culture Vials | MDB | Substantially Equivalent | |
| K222559 | BD BACTEC™ Myco/F Lytic Culture Vials | MDB | Substantially Equivalent | |
| K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | |
| K222478 | BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device | JKA | Substantially Equivalent | |
| K223653 | BD Vaginal Panel | PQA | Substantially Equivalent | |
| K223286 | BD AutoShield Duo™ Pen Needle | FMI | Substantially Equivalent | |
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | JTN | Substantially Equivalent | |
| K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets | FMK | Substantially Equivalent | |
| K220607 | BD MAX Enteric Viral Panel | PCH | Substantially Equivalent | |
| K220193 | BD MAX Enteric Parasite Panel | PCH | Substantially Equivalent | |
| K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | PCI | Substantially Equivalent | |
| K213955 | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | QTI | Substantially Equivalent | |
| K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | BSP | Substantially Equivalent | |
| K213478 | BD Pen Needle | FMI | Substantially Equivalent | |
| K210983 | BD Epilor Syringe | CAZ | Substantially Equivalent | |
| K210585 | BD CTGCTV2 | QEP | Substantially Equivalent | |
| K213616 | BD Surgiphor Antimicrobial Irrigation System | FQH | Substantially Equivalent | |
| K212499 | BD Insulin Syringe (0.3mL) | FMF | Substantially Equivalent | |
| K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set | JKA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2243072 | 2243072 | BECTON DICKINSON | 1 Becton Dr, FRANKLIN LAKES, NJ 07417 US | 2026 | and 42 more, listed in full below |
| 1911916 | 1911916 | BECTON DICKINSON AND COMPANY | 2153 12th Ave, COLUMBUS, NE 68601 US | 2026 | and 7 more, listed in full below |
| 9680577 | 1000366600 | BECTON DICKINSON GMBH | TULLASTRASSE 8-12, HEIDELBERG Baden-Wurttemberg 69126 DE | 2026 | |
| 3002682307 | 3002682307 | BECTON DICKINSON, S.A. | CR MEQUINENZA, S/N, FRAGA Huesca 22520 ES | 2026 | |
| 3003152976 | 3003152976 | BECTON DICKINSON, S.A. | CAMINO DE VALDEOLIVIA, S/N, SAN AGUSTIN DE GUADALIX Madrid(Province) 28750 ES | 2026 | |
| 1111096 | 1111096 | BECTON, DICKINSON & CO. | 250 Schilling Cir, Cockeysville, MD 21030 US | 2026 | and 6 more, listed in full below |
| 1119779 | 1119779 | BECTON, DICKINSON & CO. | 7 LOVETON CIR., SPARKS, MD 21152 US | 2026 | and 92 more, listed in full below |
| 1917413 | 1917413 | BECTON, DICKINSON & CO. | 150 S 1st Ave, BROKEN BOW, NE 68822 US | 2026 | and 3 more, listed in full below |
| 3007886372 | 3007886372 | BECTON, DICKINSON & CO. | 3750 Torrey View Ct, San Diego, CA 92130 US | 2026 | |
| 9616657 | 3005698992 | BECTON, DICKINSON AND CO. | DONORE RD., DROGHEDA Louth -- IE | 2026 | |
| 3032916632 | 3032916632 | BECTON, DICKINSON AND COMPANY | 17200 Laguna Canyon Rd, Irvine, CA 92618 US | 2026 | and 26 more, listed in full below |
| 2247224 | 1000122089 | Beaver-Visitec International, Inc | 39 Sycamore Avenue, Little Silver, NJ 07739 US | 2026 | |
| 1211998 | 1211998 | Beaver-Visitec International, Inc. | 303 Wyman St Ste 350, Waltham, MA 02451 US | 2026 | and 44 more, listed in full below |
| 3013421458 | 3013421458 | Beaver-Visitec International, Inc. | Valle del Cedro No. 1520, Parque Industrial Intermex, Ciudad Juarez Chihuahua CP 32575 MX | 2026 | and 26 more, listed in full below |
| 9680620 | 3002808441 | Beaver-Visitec International, Ltd | WATERLOO INDUSTRIAL ESTATE, BIDFORD-ON-AVON Warwickshire B50 4JH GB | 2026 | and 21 more, listed in full below |
| 3015983454 | 3015983454 | Becton Dickinson Pty Ltd | 66 Waterloo Road, Macquarie Park New South Wales 2113 AU | 2026 | |
| 1213809 | 1213809 | Becton, DIckinson and Company | ROUTE 7 AND GRACE WAY, CANAAN, CT 06018 US | 2026 | |
| 3008007472 | 3008007472 | Becton, Dickinson and Company | 1022 CORPORATE PARK DRIVE, Mebane, NC 27302 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAZAnesthesia Conduction Kit
- GMQAntigens, Nontreponemal, All
- GNAAntisera, All Types, Escherichia Coli
- GNBAntisera, All Types, Shigella Spp.
- GMPAntisera, Control For Nontreponemal Tests
- EMXBalloon, Epistaxis
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- GESBlade, Scalpel
- GECBrush, Scrub, Operating-Room
- FGYCannula, Injection
- FEZCatheter And Tube, Suprapubic
- BSOCatheter, Conduction, Anesthetic
- DXECatheter, Embolectomy
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- DQECatheter, Oximeter, Fiber-Optic
- DQYCatheter, Percutaneous
- GDJClamp, Surgical, General & Plastic Surgery
- DXCClamp, Vascular
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- FMHContainer, Specimen, Sterile
- FLLContinuous Measurement Thermometer
- GKZCounter, Differential Cell
- DREDilator, Vessel, For Percutaneous Catheterization
- GIFDiluent, Blood Cell
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- CGAGlucose Oxidase, Glucose
- FYAGown, Surgical
- GDFGuide, Needle, Surgical
- GDZHandle, Scalpel
- GHYHematocrit, Tube, Rack, Sealer, Holder
- GDGHook, Surgical, General & Plastic Surgery
- DYBIntroducer, Catheter
- FQHLavage, Jet
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FMINeedle, Hypodermic, Single Lumen
- DSBPlethysmograph, Impedance
- GEXPowered Laser Surgical Instrument
- DSFRecorder, Paper Chart
- FNSRing Cutter
- GDXScalpel, One-Piece
- FPASet, Administration, Intravascular
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- GJHStain, Reticulocyte
- FOXStand, Infusion
- FGEStents, Drains And Dilators For The Biliary Ducts
- FMGStopcock, I.V. Set
- FMFSyringe, Piston
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- GAXTourniquet, Nonpneumatic
- DRSTransducer, Blood-Pressure, Extravascular
- DXOTransducer, Pressure, Catheter Tip
- GIOTube, Collection, Capillary Blood
- GHCTube, Sedimentation Rate
- GIMTubes, Vacuum Sample, With Anticoagulant
Recall records
Showing 25 of 754| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2257-2026 | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2256-2026 | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2255-2026 | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2254-2026 | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2253-2026 | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2252-2026 | BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2251-2026 | BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2250-2026 | BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2249-2026 | BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2248-2026 | BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609. | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Class I | Open, Classified | |
| Z-2204-2026 | Swan-Ganz Pacing Catheter, Models: D200F7; | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | Class II | Open, Classified | |
| Z-2203-2026 | Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | Class II | Open, Classified | |
| Z-2202-2026 | Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8; | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | Class II | Open, Classified | |
| Z-1983-2026 | 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. | Class II | Open, Classified | |
| Z-1982-2026 | 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. | Class II | Open, Classified | |
| Z-1496-2026 | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. | During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. | Class II | Open, Classified | |
| Z-1008-2026 | BVI Leos Laser and Endoscopy System. Model Number: OME6000U. | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable). | Class II | Open, Classified | |
| Z-0484-2026 | 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. | Class II | Open, Classified | |
| Z-0504-2026 | BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; | BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. | Class II | Open, Classified | |
| Z-0240-2026 | 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. | Class II | Open, Classified | |
| Z-0239-2026 | 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. | Class II | Open, Classified | |
| Z-0238-2026 | 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. | Class II | Open, Classified | |
| Z-0237-2026 | 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. | Class II | Open, Classified | |
| Z-0236-2026 | 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. | Class II | Open, Classified | |
| Z-0235-2026 | 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. | Class II | Open, Classified |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Becton Dickinson & Co edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain