FDA Device Recalls

Recalls / Firms / Becton Dickinson & Co.

Becton Dickinson & Co.

161 FDA device recalls on record.

DateClassProductReason
2025-10-23BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
2025-09-23BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology Syste
2025-09-23BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 4
2025-09-23BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MA
2025-09-23BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epic
2025-09-23BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged
2025-09-23BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Tr
2025-06-23BD COR System Software. Model Number: 444829.
2025-05-20BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium
2025-02-12BD BBL TB Stain Kit K, Catalog (REF): 212522
2024-12-19BD PCR Cartridges used with MAX System. Model Number: 437519
2024-11-06BD BBL Sensi Disc Ampicillin 2 g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 g (AM-2) are used
2024-10-31BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
2024-10-31BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
2024-10-31BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
2024-10-31BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
2024-10-31BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
2024-10-31BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
2024-10-31BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
2024-10-31BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 44
2024-10-31BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
2024-10-31BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
2024-10-31BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
2024-10-31BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number:
2024-10-31BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
2024-09-12BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standa
2024-08-01BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibili
2024-08-01BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (
2024-07-18BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium
2024-07-09BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444
2024-05-07BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngea
2024-02-29BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology
2024-02-29BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology
2024-01-08BD BBL Sensi Disc Azithromycin -15 g, Catalog Number 231682used for semi-quantitative in vitro susce
2024-01-08BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility testing. Catal
2024-01-08BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vi
2024-01-08BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptib
2024-01-08BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing
2024-01-08BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Ca
2024-01-08BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Cata
2024-01-08BD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in vitro susceptib
2024-01-08BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Ca
2024-01-08BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing.
2024-01-08BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Cat
2024-01-08BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Ca
2024-01-08BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. C
2024-01-08BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catal
2024-01-08BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalo
2024-01-08BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing.
2024-01-08BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Cata
2024-01-08BD BBL Sensi Disc Ampicillin - 10 g, Catalog No. 230705 and 231264; 2 g, Catalog No. 231263. Used fo
2024-01-08BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Ca
2024-01-08BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. C
2024-01-08Sensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and 231629. These discs ar
2024-01-08BD BBL Sensi Disc Cefepime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Cat
2024-01-08BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catal
2024-01-08BD BBL Sensi Disc Cefaclor - 30 ug, used for semi-quantitative in vitro susceptibility testing. Cata
2024-01-08BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Cat
2024-01-08BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Ca
2024-01-08BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Ca
2024-01-08BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. C
2024-01-08BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Cata
2024-01-08BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 g, Catalog Number 231660. Used for semi-quantita
2023-09-12BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
2023-06-08BD Synapsys Informatics Solution, Catalog Number 444150
2023-05-01BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended
2023-03-22BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the
2022-11-21BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Nu
2022-10-13BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and suscepti
2022-03-09BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
2022-01-05BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog
2021-03-24BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of
2021-03-17BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from s
2021-03-17BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria fr
2021-01-07BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. S
2020-12-08BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive b
2020-12-08BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive
2020-12-08BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive
2020-12-08BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive
2020-12-08BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive ba
2020-12-08BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive ba
2020-12-08BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive ba
2020-12-08BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive
2020-07-20BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500
2020-04-14BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number:
2020-04-14BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 2
2020-04-14BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Cata
2019-07-26BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 4472
2019-07-26BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
2019-07-17Kit BD Max GC RT PCR Assay; Catalog # 443486
2019-07-17Kit BD Max ExK DNA 2 USA; Catalog # 442819
2019-07-17Kit BD Max Vaginal Panel; Catalog # 443712
2019-07-17Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
2019-07-17Kit BD Max ExK TNA 2; Catalog # 442825
2019-07-17Kit BD Max MRSA; Catalog # 442953
2019-07-17Kit BD Max StaphSR; Catalog # 443418
2019-07-17Kit BD Max MRSA XT; Catalog # 443461
2019-07-17Kit BD Max Enteric Viral Panel EU Catalog # 443985
2019-07-17Kit EXT Enteric Bacterial Panel; Catalog # 443812
2019-07-17Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
2019-07-17Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
2019-07-17Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
2019-07-17Kit BD Max ExK DNA 1 USA; Catalog # 442817
2019-07-17Kit BD Max Cdiff EU; Catalog # 442555
2019-07-17Kit BD Max Enteric Viral Panel RUO; Catalog # 443715
2019-07-17Kit BD Max StaphSR; Catalog # 443419
2019-07-17Kit BD Max CT/GC/TV; Catalog # 442970
2019-07-17Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
2019-04-03BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devic
2019-04-03BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalo
2019-02-21BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory
2019-01-14BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 4
2018-12-20Phoenix AST Indicator, Catalog Number 246004
2018-12-20Phoenix AST-s Indicator, Catalog Number 246009
2018-12-20Phoenix AP AST Indicator Bag, Catalog Number 246006
2018-10-22BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential
2017-10-03Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impuri
2017-07-18BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vagi
2017-07-18BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of va
2017-07-18BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of
2017-06-01BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD
2017-05-22TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with
2017-05-11BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025
2015-03-27BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglob
2010-01-25BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, an
2009-12-09Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickins
2009-11-11BD BACTEC(TM) Plus Anaerobic/F Medium, catalog 442193, packed in tubes, 50 tubes/case and labeled in
2009-11-11BD BACTEC(TM) Lytic 10 Anaerobic/F Medium, catalog 442265, packed in tubes, 50 tubes/case and labele
2009-11-11BD BACTEC(TM) Standard 10 Aerobic/F Medium, catalog 442260, packed in tubes, 50 tubes/case and label
2009-11-11BD BACTEC(TM) Plus + Aerobic/F Medium, catalog 442192, packed in tubes, 50 tubes/case and labeled in
2009-09-28BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers,
2009-09-18BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog nu
2009-08-17CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge,
2009-02-19BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is
2007-11-30Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or pack
2007-11-30Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and label
2007-02-19BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, l
2006-08-17BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tes
2006-01-17BD PhoenixSpec Nephelometer, Catalog #440910.
2005-12-01BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit
2005-11-23BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packe
2005-07-28Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 p
2005-01-10BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage
2004-10-29BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708
2004-09-29Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8
2004-07-02BBL Brain Heart Infusion Agar CC w/Sheep Blood - Catalog Number 296178.
2004-07-02Sheep Blood, Defibrinated - Catalog Number 212390, Unit 60 ml.
2004-07-02Sheep Blood, Defibrinated - Catalog Number 211947, Unit 500 ml.
2004-07-02Sheep Blood, Defibrinated - Catalog Number 211946, Unit 100 ml.
2004-07-02BBL Brain Heart Infusion Agar w/10% Sheep Blood - Catalog Number 297655.
2004-07-02BBL Columbia C.N.A. Agar w/5% Sheep Blood - Catalog Number 297831.
2004-07-02Sheep Blood, Defibrinated - Catalog Number 212391, Unit 250 ml.
2004-07-02Sheep Blood, Defibrinated - Catalog Number 211945, Unit 15 ml.
2004-07-02BBL Columbia C.N.A. Agar w/5% Sheep Blood/Levine EMB - Catalog Number 295618.
2004-07-02BBL TSA II w/5% Sheep Blood, Spacesaver - Catalog Number 292537.
2004-07-02Sheep Blood, Defibrinated - Catalog Number 212389, Unit 30 ml.
2003-12-15Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests,
2003-10-10Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological media plates, Catalo
2003-08-11BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
2003-07-21Becton Dickinson's ProbeTec (tm) ET Instrument
2002-11-18Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog