Becton Dickinson & Co.

FDA Regulatory Profile

Summary

Total Recalls
352 (6 Class I)
510(k) Clearances
2
Inspections
28
Compliance Actions
2

Known Names

becton dickinson and, becton, dickinson and, becton, dickinson and co., (bd)

Recent Recalls

NumberClassProductDate
Z-1496-2026Class II10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units peJanuary 27, 2026
Z-0484-2026Class IIBD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;October 23, 2025
Z-0504-2026Class IIBD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;October 14, 2025
Z-0237-2026Class IIBD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers:September 23, 2025
Z-0239-2026Class IIBD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology SysSeptember 23, 2025
Z-0235-2026Class IIBD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System EpSeptember 23, 2025
Z-0238-2026Class IIBD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD September 23, 2025
Z-0240-2026Class IIBD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. September 23, 2025
Z-0236-2026Class IIBD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, PackagSeptember 23, 2025
Z-2162-2025Class IIBD COR System Software. Model Number: 444829.June 23, 2025
Z-2023-2025Class IIBD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium May 20, 2025
Z-1296-2025Class IIBD BBL TB Stain Kit K, Catalog (REF): 212522February 12, 2025
Z-1004-2025Class IIBD PCR Cartridges used with MAX System. Model Number: 437519December 19, 2024
Z-0621-2025Class IIBD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are useNovember 6, 2024
Z-0585-2025Class IIBD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887October 31, 2024
Z-0590-2025Class IIBD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916October 31, 2024
Z-0589-2025Class IIBD COR GX Instrument Version or Model: 443990 Catalog Number: 443990October 31, 2024
Z-0593-2025Class IIBD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385October 31, 2024
Z-0586-2025Class IIBD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: October 31, 2024
Z-0596-2025Class IIBACTEC 9240 System Version or Model: 445475 Catalog Number: 445475October 31, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K170386BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD UApril 12, 2017
K163637BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)March 21, 2017