Becton, Dickinson and Company

Medical device manufacturer in Irvine, CA.

140510(k) clearances
1PMA approvals
29recalls

Device types

510(k) clearances

510(k)DeviceDecision
K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesJKA · Special 04/15/2026SE
K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood…JKA · Traditional 04/10/2026SE
K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood…JKA · Traditional 04/10/2026SE
K260184Onclarity™ Self-Collection KitSEP · Traditional 04/02/2026SE
K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional 03/13/2026SE
K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeNGT · Traditional 12/02/2025SE
K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…PCI · Traditional 10/31/2025SE
K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)ONB · Traditional 09/12/2025SE
K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)LON · Traditional 08/08/2025SE
K251350BD Plastipak™ SyringeFMF · Traditional 07/29/2025SE
K243207BD Vacutainer® Eclipse™ Blood Collection NeedleJKA · Traditional 07/03/2025SE
K243872BD Veritor System for SARS-CoV-2QVF · Dual Track 06/16/2025SE
K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)LON · Traditional 05/19/2025SE
K243649BD Vacutainer® Multiple Sample Luer AdapterJKA · Traditional 03/21/2025SE
K250344BD Phoenix™ Automated Microbiology SystemLON · Special 03/06/2025SE
K243725BD Vaginal PanelPQA · Special 12/19/2024SE
K242320BD Vacutainer® One Use HolderJKA · Traditional 11/01/2024SE
K240455BD Vacutainer® Citrate Blood Collection TubesGIM · Traditional 10/31/2024SE
K233986BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)LON · Traditional 03/15/2024SE
K231373BD Vacutainer® K2 EDTA Blood Collection TubesJKA · Traditional 02/02/2024SE
K231237BD Vacutainer® Fluoride Blood Collection TubesJKA · Traditional 01/19/2024SE
K230855BD Vacutainer® Serum Separator (SST™) Blood Collection TubesJKA · Traditional 12/20/2023SE
K230391BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood…JKA · Traditional 12/01/2023SE
K230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood…GIM · Traditional 11/27/2023SE
K222563BD Kiestra IdentifAQQV · Traditional 08/31/2023SE
K213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesGIM · Traditional 08/25/2023SE
K2311610.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush SyringeNGT · Traditional 07/21/2023SE
K213953BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum TubesJKA · Traditional 07/17/2023SE
K230651BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)JTN · Traditional 06/07/2023SE
K222591BD BACTEC™ Plus Aerobic/F Culture VialsMDB · Special 03/24/2023SE
K222559BD BACTEC™ Myco/F Lytic Culture VialsMDB · Traditional 03/24/2023SE
K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood…JKA · Traditional 03/24/2023SE
K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceJKA · Traditional 03/10/2023SE
K223653BD Vaginal PanelPQA · Traditional 03/06/2023SE
K223286BD AutoShield Duo™ Pen NeedleFMI · Traditional 12/28/2022SE
K221826BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)JTN · Traditional 12/21/2022SE
K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsFMK · Traditional 12/16/2022SE
K220607BD MAX Enteric Viral PanelPCH · Traditional 09/21/2022SE
K220193BD MAX Enteric Parasite PanelPCH · Traditional 08/19/2022SE
K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelPCI · Traditional 07/28/2022SE
K2139550.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubQTI · Traditional 07/16/2022SE
K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBSP · Traditional 07/01/2022SE
K213478BD Pen NeedleFMI · Traditional 06/28/2022SE
K210983BD Epilor SyringeCAZ · Traditional 05/19/2022SE
K210585BD CTGCTV2QEP · Traditional 05/10/2022SE
K213616BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional 03/23/2022SE
K212499BD Insulin Syringe (0.3mL)FMF · Traditional 03/09/2022SE
K212724BD Vacutainer UltraTouch Push Button Blood Collection SetJKA · Traditional 02/04/2022SE
K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBSP · Traditional 12/22/2021SE
K213156BD Nano 2nd Gen Pen NeedleFMI · Special 12/08/2021SE
K212015BD Nano 2nd Gen Pen NeedleFMI · Traditional 11/19/2021SE
K191964BD Kiestra IdentifAQQV · Traditional 11/03/2021SE
K203359BD Flu+ SyringeFMF · Traditional 07/28/2021SE
K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter SystemFOZ · Traditional 06/02/2021SE
K203453BD Hypodermic SyringeFMF · Traditional 01/25/2021SE
K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…FOZ · Traditional 12/18/2020SE
K193190BD PureHub Disinfecting CapQBP · Traditional 11/09/2020SE
K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer…BSP · Traditional 09/29/2020SE
K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…OYE · Traditional 09/28/2020SE
K202446BD Preset Syringe & BD A-Line SyringeJKA · Special 09/25/2020SE
K192538BD Syringe NRFit Lok and BD Syringe NRFit SlipQEH · Traditional 09/04/2020SE
K201099BD PhaSeal Optima Closed System Drug Transfer DeviceONB · Special 08/12/2020SE
K201234BD SoloShot Mini Syringe/ BD Auto Disable SyringeFMF · Traditional 07/15/2020SE
K190054BD Insulin SyringeFMF · Traditional 10/21/2019SE
K190905BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)LON · Traditional 07/01/2019SE
K182092BD Intelliport SystemPHC · Traditional 04/30/2019SE
K182589BD Plastipak SyringeFMF · Traditional 03/14/2019SE
K181730BD Vacutainer Eclipse UltraFill Blood Collection NeedleFMI · Traditional 03/01/2019SE
K182692BD MAX CTGCTV2, BD MAX SystemOUY · Traditional 01/08/2019SE
K182320BD Contoured Base Pen NeedleFMI · Traditional 12/20/2018SE
K181221BD PhaSeal Optima Closed System Transfer DeviceONB · Traditional 11/30/2018SE
K181427BD MAX Enteric Viral Panel, BD MAX InstrumentPCH · Traditional 11/29/2018SE
K172670BD Single Use, Hypodermic SyringeFMF · Traditional 10/23/2018SE
K181718BD FlowSmart Set/MiniMed Pro-SetFPA · Traditional 10/18/2018SE
K181665BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNLON · Traditional 09/21/2018SE
K170824BD Vacutainer Eclipse Signal Blood Collection NeedleFMI · Traditional 08/20/2018SE
K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic…MDB · Traditional 03/16/2018SE
K173523BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)LON · Traditional 02/09/2018SE
K173252BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)LON · Traditional 01/05/2018SE
K172506BD Cathena Safety IV CatheterFOZ · Traditional 09/17/2017SE
K172204BD Intima II PLUS Closed IV Catheter SystemFOZ · Traditional 08/17/2017SE
K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…OYE · Traditional 07/03/2017SE
K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemPCH · Traditional 05/02/2017SE
K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorFOZ · Traditional 03/10/2017SE
K170283BD Nexiva Diffusics Closed IV Catheter SystemFOZ · Traditional 02/28/2017SE
K163591BD PosiFlush Heparin Lock Flush SyringeNZW · Special 02/27/2017SE
K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeNGT · Special 02/02/2017SE
K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…FMF · Traditional 12/19/2016SE
K162516BD Pen NeedleFMI · Traditional 12/09/2016SE
K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeJKA · Traditional 09/23/2016SE
K151589BD Max Ct/Gc/Tv, BD Max InstrumentOUY · Traditional 09/06/2016SE
K151870BD U-500 Insulin SyringeFMF · Traditional 07/08/2016SE
K161553BD SafeAssistFMI · Special 07/06/2016SE
K161170BD Eclipse Hypodermic NeedleFMI · Special 05/27/2016SE
K160651BD FlowSmart Set, MiniMed Pro-SetFPA · Special 04/07/2016SE
K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeNGT · Traditional 04/04/2016SE
K151866BD BACTEC Peds Plus/F Culture Vials (plastic)MDB · Traditional 02/25/2016SE
K153309BD Vacutainer UltraTouch Push Button Blood Collection SetJKA · Special 02/12/2016SE
K151320BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/mlLON · Traditional 01/15/2016SE
K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitPMG · Traditional 12/17/2015SE
K153257BD FlowSmart Set, MiniMed Pro-SetFPA · Special 12/11/2015SE
K152874BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitPSZ · Special 10/27/2015SE
K152870BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitPSZ · Special 10/27/2015SE
K152516BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test DisksJTN · Traditional 10/13/2015SE
K151766BD Single Use, Hypodermic SyringeFMF · Special 09/02/2015SE
K143648BD MAX Enteric Parasite Panel, BD MAX InstrumentPCH · Traditional 08/25/2015SE
K151291BD Veritor (TM) System for the Rapid Detection of Flu A+BPSZ · Special 06/10/2015SE
K151301BD Veritor™ System Flu A+B AssayPSZ · Special 06/08/2015SE
K141810BD Bactec Plus Anaerobic/F (Plastic)MDB · Traditional 12/10/2014SE
K142170BD Phoenix Automated Microbiology Systesm - Tigecycline (0.313-4UG/ML) GPLON · Traditional 10/28/2014SE
K1413110.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF SyringeNGT · Special 07/25/2014SE
K140468BD Phoenix Automated Microbiology System - Ceftaroline (0.625-4 Ug/Ml)LON · Traditional 06/02/2014SE
K140447BD Viper LT SystemOOI · Traditional 05/20/2014SE
K140111BD Max(Tm) Enteric Bacterial Panel;Bd Max(Tm) InstrumentPCI · Traditional 05/06/2014SE
K132909BD Phoenix Automated Microbiology System Tigecycline (0.25-16 Ug/Ml)LON · Traditional 02/14/2014SE
K132674BD Phoenix Automated Microbiology System- Meropenem (0.125-32 Ug/Ml)LON · Traditional 12/27/2013SE
K132456BD Veritor (TM) System for Rapid Detection of RSVGQG · Traditional 11/07/2013SE
K132693BD Veritor™ System Flu A+B AssayPSZ · Special 10/02/2013SE
K132692BD Veritor System for the Rapid Detection of Flu A+BPSZ · Special 09/23/2013SE
K132259BD Veritor System for the Rapid Detection of Flu A+BPSZ · Special 08/07/2013SE
K132256BD Veritor System for the Rapid Detection of Flu A+BPSZ · Special 08/07/2013SE
K123266BD Phoenix Automated Microiology System- Ertapenem 0.0625-8 Ug/Ml-GnLON · Traditional 06/26/2013SE
K130197BD Phaseal Closed System Transfer Device - P55ONB · Special 02/27/2013SE
K122718BD Veritor(Tm) System for Rapid Detection of Group a StrepGTY · Traditional 02/06/2013SE
K121633BD Veritor(Tm) System for the Rapid Detection of RSVGQG · Traditional 09/18/2012SE
K121797BD Veritor(Tm) System for Rapid Detection of Flu A+BPSZ · Traditional 09/07/2012SE
K120994BD BACTEC Plus PRIME Aerobic/F Culture VialsMDB · Traditional 08/07/2012SE
K121283BD Emerald Saf-T Single Use, HypodermicFMF · Special 05/30/2012SE
K112774BD Recykleen Sharps CollectorsMMK · Traditional 03/28/2012SE
K120049BD Veritor System for the Rapid Detection of Flu A+BPSZ · Traditional 03/23/2012SE
K113558BD BACTEC Plus Aerobic/F Culture Vials (plastic)MDB · Traditional 03/16/2012SE
K112277BD Veritor(Tm) System for Rapid Detection of Flu A+BPSZ · Traditional 10/28/2011SE
K110703BD Autoshield Duo Pen NeedleFMI · Traditional 07/27/2011SE
K110771BD Single Use, Hypodermic SyringeFMF · Special 05/13/2011SE
K101461BD Directigen Ex Flu A+BPSZ · Special 06/24/2010SE
K100005BD Pen NeedleFMI · Special 04/15/2010SE
K100722Telavancin 30 Ug, BBL Sensi-DiscJTN · Traditional 03/29/2010SE
K041572BD Phoenix Automated Microbiology System-Pipercillin (GN) 0.5-128 Ug/MlLON · Traditional 08/12/2004SE
K010890BD Ultra-Fine II Insulin Syringe-Mini Needle, Model 30G * 3/16 (5MM)FMF · Special 04/19/2001SE
K010572BD Visidrape Ophthalmic Drapes; BD Visiflex Incise DrapeKKX · Special 03/12/2001SE

PMA approvals

Recalls

RecallProductInitiated
Z-3250-2026 ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The…Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. 08/11/2026Open, Classified
Z-2204-2026 Class IISwan-Ganz Pacing Catheter, Models: D200F7;Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal… 04/08/2026Open, Classified
Z-2203-2026 Class IISwan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PCatheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal… 04/08/2026Open, Classified
Z-2202-2026 Class IISwan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P…Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal… 04/08/2026Open, Classified
Z-2164-2011 S5-7606 Silicone Oil injection Cannula 6mm Long - 20G REF 585247 High Viscosity…Restricted or no fluid flow for Visitec High Viscosity Injector. 12/17/2010Terminated
Z-2163-2011 S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity…Restricted or no fluid flow for Visitec High Viscosity Injector. 12/17/2010Terminated
Z-2162-2011 BD Visitec High Viscosity Injector 6mm .90mm (20G) [Hammer] Catalog Number: 585228 High…Restricted or no fluid flow for Visitec High Viscosity Injector. 12/17/2010Terminated
Z-2161-2011 BD Visitec High Viscosity Injector 4mm [Hammer] .90 (20G) Catalog Number: 585208 High…Restricted or no fluid flow for Visitec High Viscosity Injector. 12/17/2010Terminated
Z-2160-2011 BD Visitec High Viscosity Injector 6mm [Hammer] .90mm (20G) Catalog Number: 585184 High…Restricted or no fluid flow for Visitec High Viscosity Injector. 12/17/2010Terminated
Z-2159-2011 BD Visitec High Viscosity Injector 4mm .90 (20G) [Hammer] REF 585173 High Viscosity…Restricted or no fluid flow for Visitec High Viscosity Injector. 12/17/2010Terminated
Z-0606-2011 Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0…Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury. 10/04/2010Terminated
Z-1597-2010 BD Visitec EdgeAhead MVR Knife, BD Opthalmic Systems, Waltham, MA. Intended for use in…A field action was initiated due to a recent customer complaint from Japan there is a labeling mixup and… 04/06/2010Terminated
Z-1638-2010 BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company…Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left. 06/12/2009Terminated
Z-0022-2009 BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for…Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip. 09/15/2008Terminated
Z-2433-2008 BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref:…Metal particulates present. 07/07/2008Terminated
Z-0454-2008 BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #:…No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow 11/20/2007Terminated
Z-0453-2008 BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF…No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow. 11/20/2007Terminated
Z-0066-2008 BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea 08/09/2007Terminated
Z-0672-2007 BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617… 03/02/2007Terminated
Z-0410-2007 BD Beaver Mini-Blade, Mini/Bulk 69, Catalog Number: 374823Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0409-2007 BD Beaver Mini-Blade, Mini/Bulk 67, Catalog Number: 374822Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0408-2007 BD Beaver Mini-Blade, Mini/Bulk 64, Catalog Number: 374820Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0407-2007 BD Beaver Mini-Blade, Blade Mini Sharp All Around S/SU, Catalog Number: 376900Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0406-2007 BD Beaver Mini-Blade, Blade Mini Curved Sharp on One, Catalog Number: 376700Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0405-2007 BD Beaver Mini-Blade, Blade Mini Pointed Tip S/SU, Catalog Number: 376500Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0404-2007 BD Beaver Mini-Blade, Blade Mini RND Tip Sharp One Side, Catalog Number: 376400Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0403-2007 BD Beaver Mini-Blade, Blade Sharp Two Sides Pointed, Catalog Number: 376300Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0402-2007 BD Beaver Mini-Blade, Blade Mini Orthopedic 1.31 in, Catalog Number: 376100Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated
Z-0401-2007 BD Beaver Mini-Blade, Blade Mini Orthopedic 1.255 in, Catalog Number: 374562Product sterility may be compromised due to incomplete package seal 12/26/2006Terminated