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Becton Dickinson & Company FDA Recalls

39 recalls on file across devices, 10 of them Class I and 38 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¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivClass IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8Class IApr 27, 2026This is a sub-recall of a product recall from Huons Co, Ltd.
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.Class IIJan 27, 2026During the bulk packaging process, some Luer Slip syringes w
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;Class IIOct 14, 2025BD has confirmed through internal testing that certain devic
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number Class IINov 16, 2023An incorrect stopper was used in nine lots of 10mL BD PosiFl
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bondClass IIOct 11, 2023Affected infusion sets labeled as free of DEHP actually do c
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABClass IIOct 11, 2023Affected infusion sets labeled as free of DEHP actually do c
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter SmallboreClass IIOct 11, 2023Affected infusion sets labeled as free of DEHP actually do c
BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designClass IIFeb 1, 2023Nonsterile syringe potentially exposing the patient to patho
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment oClass IIFeb 1, 2023Nonsterile syringe potentially exposing the patient to patho
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatmenClass IIFeb 1, 2023Nonsterile syringe potentially exposing the patient to patho
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of Class IIFeb 1, 2023Nonsterile syringe potentially exposing the patient to patho
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed fClass IIFeb 1, 2023Nonsterile syringe potentially exposing the patient to patho
BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed Class IIFeb 1, 2023Nonsterile syringe potentially exposing the patient to patho
BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatmentClass IIFeb 1, 2023Nonsterile syringe potentially exposing the patient to patho
BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment Class IIFeb 1, 2023Nonsterile syringe potentially exposing the patient to patho
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transportinClass IISep 15, 2022The affected product contains isobutylene which has recently
BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanicallyClass IIJul 18, 2022Incorrect expiration date listed on the product labels. The
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)Class IIMay 9, 2022May have the potential for leakage at the housing component
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a caClass IIIJan 6, 2022May shed contaminant particles into the urine specimen that
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container clClass IISep 27, 2021Holes in product packaging impacts package integrity and may

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