RegWardenFDA facility compliance records
Facility

BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES

160 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 11 recalls; 2013: 16 recalls; 2014: 11 recalls; 2015: 8 recalls; 2016: 12 recalls; 2017: 13 recalls; 2018: 13 recalls; 2019: 23 recalls; 2020: 15 recalls; 2021: 4 recalls; 2022: 8 recalls; 2023: 7 recalls; 2024: 10 recalls; 2025: 6 recalls; 2026: 3 recalls11’1216’1311’148’1512’1613’1713’1823’1915’204’218’227’2310’246’253’26
  • Recalls (160)

Devices registered here (1)

Recalls & enforcement

20263 records
  • Class IOngoing2026-04-27
    This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to …
  • Class IIOngoing2026-04-07
    BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
  • Class IIOngoing2026-01-27
    During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
20256 records
  • Class IIOngoing2025-10-23
    The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
  • Class IIOngoing2025-10-14
    BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
  • Class IIOngoing2025-09-23
    Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and…
  • Class IIOngoing2025-06-23
    Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
  • Class IIOngoing2025-05-20
    BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
  • Class IIOngoing2025-02-12
    One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
202410 records
  • Class IIOngoing2024-12-19
    Potential for signal drift in specific lots of BD PCR Cartridges.
  • Class IIOngoing2024-11-06
    BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
  • Class IIOngoing2024-10-31
    BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidential…
  • Class IIOngoing2024-09-12
    Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identif…
  • Class IIOngoing2024-08-01
    Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
  • Class IIOngoing2024-07-18
    May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
  • Class IIOngoing2024-07-09
    There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.
  • Class IIOngoing2024-05-07
    Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
  • Class IIOngoing2024-02-29
    Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abor…
  • Class IIOngoing2024-01-08
    There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappro…
20237 records
  • Class IIOngoing2023-11-16
    An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if use…
  • Class IIOngoing2023-10-11
    Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
  • Class IIOngoing2023-09-12
    Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.
  • Class IIOngoing2023-06-08
    There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.
  • Class IIOngoing2023-05-01
    IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false posi…
  • Class IIOngoing2023-03-22
    Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys" after processing has occurred. This could possibly lead to a delayed diagnosis and/or treatment or need for specimen recollec…
  • Class IIOngoing2023-02-01
    Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
20228 records
  • Class IIOngoing2022-11-21
    Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.
  • Class IIOngoing2022-10-13
    Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control …
  • Class IIOngoing2022-09-15
    The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
  • Class IIOngoing2022-07-18
    Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.
  • Class IIOngoing2022-05-09
    May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
  • Class IITerminated2022-03-09
    When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
  • Class IIIOngoing2022-01-06
    May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
  • Class IIOngoing2022-01-05
    May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.
20214 records
  • Class IITerminated2021-09-27
    Holes in product packaging impacts package integrity and may compromise sterility.
  • Class IITerminated2021-03-24
    BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System
  • Class IITerminated2021-03-17
    Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in pr…
  • Class IITerminated2021-01-07
    Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel d…
202015 records
  • Class IITerminated2020-12-23
    The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
  • Class IITerminated2020-12-09
    BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications
  • Class IITerminated2020-12-08
    BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection
  • Class IITerminated2020-11-18
    BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
  • Class IITerminated2020-10-23
    Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.
  • Class IITerminated2020-09-14
    Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted
  • Class IITerminated2020-09-14
    Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
  • Class IITerminated2020-07-28
    Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.
  • Class IITerminated2020-07-20
    BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if …
  • Class IITerminated2020-06-19
    Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could re…
  • Class IITerminated2020-04-16
    This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
  • Class IITerminated2020-04-14
    May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
  • Class IITerminated2020-03-26
    The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
  • Class IITerminated2020-03-17
    Iincorrectly packaged without the required lidocaine as labeled
  • Class IITerminated2020-02-26
    The kits contain surgical gowns which were subject to a recall by the supplier.
201923 records
  • Class IITerminated2019-11-04
    The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only
  • Class IITerminated2019-10-14
    Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.
  • Class IITerminated2019-09-16
    A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
  • Class IITerminated2019-08-01
    Product Pouches may not be sealed properly and compromise the sterility of the device
  • Class IITerminated2019-07-31
    Separation of front and rear barrels upon activation of the safety feature that retracts the needle
  • Class IITerminated2019-07-26
    An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
  • Class IITerminated2019-07-17
    The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
  • Class IITerminated2019-06-12
    False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
  • Class IITerminated2019-06-03
    The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of …
  • Class IITerminated2019-05-30
    Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2…
  • Class IITerminated2019-05-13
    Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
  • Class ITerminated2019-05-06
    An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in …
  • Class IITerminated2019-05-02
    After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.
  • Class IITerminated2019-04-10
    BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection.
  • Class IITerminated2019-04-03
    Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
  • Class IITerminated2019-03-07
    BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.
  • Class IITerminated2019-03-07
    The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.
  • Class IITerminated2019-03-05
    The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
  • Class IITerminated2019-03-01
    Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
  • Class ITerminated2019-02-28
    Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
  • Class IITerminated2019-02-21
    BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
  • Class IITerminated2019-02-01
    The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
  • Class IITerminated2019-01-14
    False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.
201813 records
  • Class IITerminated2018-12-20
    Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
  • Class IITerminated2018-10-22
    a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
  • Class IITerminated2018-09-26
    The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
  • Class IITerminated2018-09-24
    A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
  • Class IIITerminated2018-09-21
    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 th…
  • Class IITerminated2018-08-30
    BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as pe…
  • Class IITerminated2018-08-23
    One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.
  • Class IITerminated2018-06-21
    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 negati…
  • Class IITerminated2018-04-11
    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%.
  • Class ITerminated2018-03-22
    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 o…
  • Class IITerminated2018-03-20
    Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
  • Class IIITerminated2018-03-02
    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.
  • Class IITerminated2018-02-13
    Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
201713 records
  • Class IITerminated2017-10-03
    HighPuragar was mislabeled and inadvertently sold as Noble Agar.
  • Class IITerminated2017-09-18
    Increased amount of residual blood present on the top of stopper well after venipuncture
  • Class IITerminated2017-08-29
    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 seriou…
  • Class IITerminated2017-07-18
    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.
  • Class IITerminated2017-06-13
    Presence of loose polypropylene foreign matter above release specification.
  • Class IIITerminated2017-06-01
    Potential unexpected movement of robot arm
  • Class IITerminated2017-05-31
    Hub damage resulting in breakage and/or leakage during use.
  • Class IITerminated2017-05-25
    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 co…
  • Class IITerminated2017-05-22
    Listeria monocytogenes contamination of non-sterile plated media
  • Class IITerminated2017-05-11
    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 …
  • Class IITerminated2017-03-16
    BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper f…
  • Class IITerminated2017-01-27
    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.
  • Class IITerminated2017-01-16
    A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
201612 records
  • Class IITerminated2016-12-23
    Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.
  • Class IITerminated2016-12-20
    BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.
  • Class IITerminated2016-11-07
    BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray, Cat (Ref) 406069.
  • Class IITerminated2016-09-16
    BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
  • Class IIOngoing2016-08-08
    BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer® Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.
  • Class IITerminated2016-08-08
    Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts the needle.
  • Class IITerminated2016-08-02
    A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul, NDC # 0409-4712-01. Some BD" Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being …
  • Class IIITerminated2016-06-01
    BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but d…
  • Class IITerminated2016-03-28
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.
  • Class IITerminated2016-03-25
    BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
  • Class IITerminated2016-03-18
    The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.
  • Class IITerminated2016-02-12
    BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
20158 records
  • Class IITerminated2015-12-09
    The sterility of the product cannot be assured. This may result in increased risk of infection.
  • Class IITerminated2015-12-03
    Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
  • Class IITerminated2015-11-17
    Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
  • Class IITerminated2015-08-27
    BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
  • Class IITerminated2015-06-29
    The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 2…
  • Class IIITerminated2015-06-23
    Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.
  • Class IIITerminated2015-03-27
    BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.
  • Class IITerminated2015-02-19
    Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
201411 records
  • Class IITerminated2014-12-19
    The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.
  • Class IITerminated2014-11-21
    The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.
  • Class IITerminated2014-11-07
    Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument.
  • Class IITerminated2014-10-09
    BD Insyte Autoguard may have potential damage along the body of the catheter.
  • Class IITerminated2014-08-25
    The information in the EpiCenter interface translation tables was not updated to match the Bruker MALDI BioTyper database identifications for some organisms. This could lead to a possible mis-identification of an organism.
  • Class IITerminated2014-07-28
    These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Agar that allows susceptible enterococci to grow appears as a falsely resistant culture. If a lab does not QC, the error would be identified as falsely resi…
  • Class IITerminated2014-07-23
    The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX M…
  • Class IITerminated2014-07-22
    BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
  • Class IITerminated2014-07-03
    BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
  • Class IITerminated2014-06-06
    A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when p…
  • Class IIITerminated2014-05-21
    A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on…
201316 records
  • Class IITerminated2013-12-09
    Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
  • Class IITerminated2013-11-26
    BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.
  • Class IITerminated2013-10-11
    An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
  • Class IITerminated2013-09-09
    An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
  • Class IITerminated2013-08-23
    BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.
  • Class IITerminated2013-07-10
    The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
  • Class IITerminated2013-07-08
    PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.
  • Class IITerminated2013-06-13
    In vitro diagnostic test kit may exhibit invalid internal negative control results.
  • Class IITerminated2013-06-06
    Microbiological identification media may exhibit reduced levels of Vancomycin.
  • Class IIITerminated2013-05-31
    Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
  • Class IITerminated2013-05-01
    There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.
  • Class IITerminated2013-05-01
    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.
  • Class IITerminated2013-04-12
    In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
  • Class IITerminated2013-03-11
    Microbiological media may be contaminated with bacteria.
  • Class IIITerminated2013-02-14
    The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag l…
  • Class IITerminated2013-02-08
    Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
201211 records
  • Class IITerminated2012-12-13
    In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.
  • Class IITerminated2012-12-11
    Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
  • Class IITerminated2012-12-10
    Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
  • Class IITerminated2012-11-12
    BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.
  • Class IITerminated2012-11-06
    An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
  • Class IITerminated2012-10-22
    In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.
  • Class IITerminated2012-10-02
    BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
  • Class IITerminated2012-09-18
    Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
  • Class IITerminated2012-05-22
    Leakage in Cepheid SmartCycler reaction tubes.
  • Class IITerminated2012-04-12
    Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
  • Class IIITerminated2012-03-05
    BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES (FEI 3015292643) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015292643-becton-dickinson-and-company-bd-bioscien/

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