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Becton Dickinson & Co. FDA Recalls
77 recalls on file across devices, 0 of them Class I and 72 still open. Matched by name to BDX.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic useClass IIApr 7, 2026BD identified an issue affecting certain lots of BD GasPak E |
| BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic useClass IIApr 7, 2026BD identified an issue affecting certain lots of BD GasPak E |
| BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;Class IIOct 23, 2025The 2D barcodes on these cuvettes contain formatting errors |
| BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro dClass IISep 23, 2025Product service credentials used by some BD technical suppor |
| BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog NumbersClass IISep 23, 2025Product service credentials used by some BD technical suppor |
| BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. Class IISep 23, 2025Product service credentials used by some BD technical suppor |
| BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, CatalogClass IISep 23, 2025Product service credentials used by some BD technical suppor |
| BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, CataClass IISep 23, 2025Product service credentials used by some BD technical suppor |
| BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: Class IISep 23, 2025Product service credentials used by some BD technical suppor |
| BD COR System Software. Model Number: 444829.Class IIJun 23, 2025Potential for functionality issue that supports the Over la |
| BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culClass IIMay 20, 2025BD has received additional complaints of intermittent false |
| BD BBL TB Stain Kit K, Catalog (REF): 212522Class IIFeb 12, 2025One component of the kit was shipped with an expiration date |
| BD PCR Cartridges used with MAX System. Model Number: 437519Class IIDec 19, 2024Potential for signal drift in specific lots of BD PCR Cartri |
| BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitatClass IINov 6, 2024BD identified through potency testing as part of a stability |
| BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570Class IIOct 31, 2024BD confirmed that product service credentials used by some B |
| BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory sofClass IISep 12, 2024Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 a |
| BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of Class IIAug 1, 2024Escherichia coli (E. coli) misidentification for clinical sa |
| BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically sClass IIAug 1, 2024Escherichia coli (E. coli) misidentification for clinical sa |
| BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cClass IIJul 18, 2024May intermittently produce falsely resistant results for pyr |
| BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;Class IIJul 9, 2024There is a potential risk that the image colony count does n |
| BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swaClass IIMay 7, 2024Assays may produce false negative results due to decreased a |
| BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene Class IIFeb 29, 2024Esculin, a substrate used in other panels and normally in A |
| BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene Class IIFeb 29, 2024Products were found to have confirmed drug cross contaminati |
| BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 23125Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 aClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitativClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-qClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 anClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 23164Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility tClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. CatalClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 anClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 andClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceClass IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 2316Class IIJan 8, 2024There is a possibility of reproducibility, accuracy, and/or |
| BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023Class IISep 12, 2023Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials |
| BD Synapsys Informatics Solution, Catalog Number 444150Class IIJun 8, 2023There is a risk of mis-association of patient demographic da |
| BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, sClass IIMay 1, 2023IFU- Instructions for Use (IFU) package insert and both the |
| BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform.Class IIMar 22, 2023Upon installation of BD Kiestra" InoqulA+" and BeA version 5 |
| BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267Class IINov 21, 2022Boxes contain a reduced concentration of Nicotinamide Adenin |
| BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobClass IIOct 13, 2022Misformulated minocycline-can cause erroneously increased Mi |
| BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10Class IIMar 9, 2022When updating BD Kiestra customers to BD Synapsys version 4. |
| BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066Class IIJan 5, 2022May have the potential to overheat and/or cause fire, the |
| BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from thClass IIMar 24, 2021BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buf |
| BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing Class IIMar 17, 2021Products show heavy growth of C. albicans after 24 hours of |
| BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containClass IIMar 17, 2021Products show heavy growth of C. albicans after 24 hours of |
| BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 ReagentsClass IIJan 7, 2021Some N1 and N2 master mix pouches packaged within the lots o |