Drug & Device Safety Atlas

FDA recall record · openFDA

Becton Dickinson & Co.

69 FDA recalls on record (2023–2026) — 69 device. 69 still ongoing.

0
Class I (most serious)
69
Class II
0
Class III
69
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H 30
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were 13
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an un 6
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, w 2
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD 2

Recalls

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use Class II 2026-04-07 BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use Class II 2026-04-07 BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cul Class II 2025-05-20 BD BBL TB Stain Kit K, Catalog (REF): 212522 Class II 2025-02-12 BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Class II 2025-09-23 BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. Class II 2025-09-23 BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro d Class II 2025-09-23 BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: Class II 2025-09-23 BD COR System Software. Model Number: 444829. Class II 2025-06-23 BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; Class II 2025-10-23 BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Cata Class II 2025-09-23 BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers Class II 2025-09-23 BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catal Class II 2024-01-08 BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing. Class II 2024-01-08 BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and Class II 2024-01-08 BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of Class II 2024-08-01 BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 Class II 2024-01-08 Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-q Class II 2024-01-08 BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 23125 Class II 2024-01-08 BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿ Class II 2024-01-08 BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 Class II 2024-01-08 BD PCR Cartridges used with MAX System. Model Number: 437519 Class II 2024-12-19 BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 a Class II 2024-01-08 BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically s Class II 2024-08-01 BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990 Class II 2024-10-31 BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150 Class II 2024-10-31 BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 an Class II 2024-01-08 BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916 Class II 2024-10-31 BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231 Class II 2024-01-08 BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿ Class II 2024-01-08 BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and Class II 2024-01-08 BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿ Class II 2024-01-08 BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230 Class II 2024-01-08 BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385 Class II 2024-10-31 BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 an Class II 2024-01-08 BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007 Class II 2024-10-31 BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from c Class II 2024-07-18 BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657 Class II 2024-01-08 BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 23164 Class II 2024-01-08 BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 Class II 2024-01-08 BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing. Class II 2024-01-08 BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility t Class II 2024-01-08 BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿ Class II 2024-01-08 BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981 Class II 2024-10-31 BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿ Class II 2024-01-08 BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿ Class II 2024-01-08 BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475 Class II 2024-10-31 BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989 Class II 2024-10-31 BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887 Class II 2024-10-31 BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitativ Class II 2024-01-08 BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene Class II 2024-02-29 BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988 Class II 2024-10-31 BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296 Class II 2024-10-31 BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory sof Class II 2024-09-12 BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitat Class II 2024-11-06 BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿ Class II 2024-01-08 BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570 Class II 2024-10-31 BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 Class II 2024-01-08 BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624 Class II 2024-10-31 BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swa Class II 2024-05-07 BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900; Class II 2024-07-09 BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿ Class II 2024-01-08 BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene Class II 2024-02-29 BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susce Class II 2024-01-08 BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 2316 Class II 2024-01-08 BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, s Class II 2023-05-01 BD Synapsys Informatics Solution, Catalog Number 444150 Class II 2023-06-08 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 II 2023-03-22 BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023 Class II 2023-09-12

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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