Recall archive
74 recalls · page 1 of 4
Reported May 6, 2026
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a…
FDA (openFDA device enforcement)
Reported Oct 29, 2025
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
BD COR System Software. Model Number: 444829.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
FDA (openFDA device enforcement)
Reported Jul 2, 2025
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis…
FDA (openFDA device enforcement)
Reported Mar 12, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of…
FDA (openFDA device enforcement)
Reported Jan 29, 2025
BD PCR Cartridges used with MAX System. Model Number: 437519
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Potential for signal drift in specific lots of BD PCR Cartridges.
FDA (openFDA device enforcement)
Reported Dec 11, 2024
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Oct 2, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2024
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
FDA (openFDA device enforcement)
Reported Aug 21, 2024
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jun 12, 2024
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
FDA (openFDA device enforcement)
Reported Apr 10, 2024
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause…
29 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 18, 2023
BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on…
FDA (openFDA device enforcement)
Reported Jul 12, 2023
BD Synapsys Informatics Solution, Catalog Number 444150
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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)…
FDA (openFDA device enforcement)
Reported Jun 14, 2023
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Apr 26, 2023
BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Dec 21, 2022
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support…
FDA (openFDA device enforcement)
Reported Nov 23, 2022
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility…
FDA (openFDA device enforcement)
Reported May 11, 2022
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Feb 16, 2022
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Apr 21, 2021
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
Matched: Brand — 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…
FDA (openFDA device enforcement)
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