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Becton Dickinson & Recalls
364 recalls on record · July 25, 2012 to June 10, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
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The recall feeds record what looks like the same company under more than one name:
October 17, 2018Medical DevicesFDA
Becton Dickinson & Co. recalls BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 4
Hazard: The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in which case slides would require manual screening. Therefore, no slides are screened by the device and no results can be released in error. The instrument labeling has been revised to indicate an operating temperature lower limit of 18 deg. C and operating humidity of 20 to 80% relative humidity.
August 29, 2018Medical DevicesFDA
Becton Dickinson & Co. recalls BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neis
Hazard: A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment.
June 27, 2018Medical DevicesFDA
Becton Dickinson & Company recalls The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means
Hazard: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
June 27, 2018Medical DevicesFDA
Becton Dickinson & Company recalls The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means
Hazard: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
June 27, 2018Medical DevicesFDA
Becton Dickinson & Company recalls The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means
Hazard: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
June 13, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
Hazard: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
June 13, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
Hazard: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
May 9, 2018Medical DevicesFDA
Becton Dickinson & Co. recalls BD MAX DNA MMK Lab Use, catalog no. 442828
Hazard: The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
May 9, 2018Medical DevicesFDA
Becton Dickinson & Co. recalls BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Hazard: The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
May 2, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Hazard: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
May 2, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Hazard: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
May 2, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
Hazard: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
April 4, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 3650
Hazard: Increased amount of residual blood present on the top of stopper well after venipuncture
March 28, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 5038290
Hazard: BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
March 28, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3.
Hazard: BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
March 28, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
Hazard: BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
March 28, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509
Hazard: BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
March 21, 2018Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for who
Hazard: A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
March 21, 2018Medical DevicesFDA
Becton Dickinson & Co. recalls Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used i
Hazard: HighPuragar was mislabeled and inadvertently sold as Noble Agar.
January 31, 2018Medical DevicesFDA
Becton Dickinson & Co. recalls BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocerv
Hazard: BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
January 31, 2018Medical DevicesFDA
Becton Dickinson & Co. recalls BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervica
Hazard: BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
January 31, 2018Medical DevicesFDA
Becton Dickinson & Co. recalls BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endoce
Hazard: BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
December 13, 2017Medical DevicesFDA
Becton Dickinson & Company recalls BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose
Hazard: Hub damage resulting in breakage and/or leakage during use.
December 13, 2017Medical DevicesFDA
Becton Dickinson & Co. recalls BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is
Hazard: Potential unexpected movement of robot arm
December 13, 2017Medical DevicesFDA
Becton Dickinson & Co. recalls TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Bl
Hazard: Listeria monocytogenes contamination of non-sterile plated media
December 6, 2017Medical DevicesFDA
Becton Dickinson & Company recalls BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are inten
Hazard: Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle ¿mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle ¿mL 12.7mm 30G.
December 6, 2017Medical DevicesFDA
Becton Dickinson & Co. recalls BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is
Hazard: BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. The iMLSb resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. As the product should not be used when quality control (QC) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform QC testing and uses the panel, there is a potential to incorrectly treat a Staphylococcus infection with clindamycin based on the iMLSb test result. This issue can be detected 100% of the time when used per package insert instructions with iMLSb positive strain S. aureus BAA-977.
November 15, 2017Medical DevicesFDA
Becton Dickinson & Company recalls BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological St
Hazard: After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case and shelf pack level.
November 1, 2017DrugsFDA
Becton Dickinson & Company recalls ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator,
Hazard: Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
September 20, 2017Medical DevicesFDA
Becton Dickinson & Company recalls BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be
Hazard: Presence of loose polypropylene foreign matter above release specification.