Browse Device Recalls

183 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 183 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 183 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jan 8, 2024	BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro suscep...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro sus...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro su...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susce...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susc...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro su...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susc...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro s...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 an...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro su...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro suscept...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-qu...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Jan 8, 2024	BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantita...	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil...	Class II	Becton Dickinson & Co.
Sep 12, 2023	BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023	Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicat...	Class II	Becton Dickinson & Co.
Jun 8, 2023	BD Synapsys Informatics Solution, Catalog Number 444150	There is a risk of mis-association of patient demographic data for users who choose to report res...	Class II	Becton Dickinson & Co.
May 1, 2023	BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use ...	IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and th...	Class II	Becton Dickinson & Co.
Mar 22, 2023	BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 a...	Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A...	Class II	Becton Dickinson & Co.
Nov 21, 2022	BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria sp...	Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide e...	Class II	Becton Dickinson & Co.
Oct 13, 2022	BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid iden...	Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) ...	Class II	Becton Dickinson & Co.
Mar 9, 2022	BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Softwar...	When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set b...	Class II	Becton Dickinson & Co.
Jan 5, 2022	BD Veritor Plus Analyzer - intended to provide rapid test results in near-pat...	May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized ...	Class II	Becton Dickinson & Co.
Mar 24, 2021	BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qu...	BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed ...	Class II	Becton Dickinson & Co.
Mar 17, 2021	BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of path...	Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (exp...	Class II	Becton Dickinson & Co.
Mar 17, 2021	BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of ...	Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (exp...	Class II	Becton Dickinson & Co.
Jan 7, 2021	BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In...	Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MA...	Class II	Becton Dickinson & Co.
Dec 8, 2020	BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (...	BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur...	Class II	Becton Dickinson & Co.
Dec 8, 2020	BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identificatio...	BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur...	Class II	Becton Dickinson & Co.
Dec 8, 2020	BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identificatio...	BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur...	Class II	Becton Dickinson & Co.
Dec 8, 2020	BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identificatio...	BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur...	Class II	Becton Dickinson & Co.
Dec 8, 2020	BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification ...	BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur...	Class II	Becton Dickinson & Co.
Dec 8, 2020	BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (...	BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur...	Class II	Becton Dickinson & Co.
Dec 8, 2020	BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identificatio...	BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur...	Class II	Becton Dickinson & Co.
Dec 8, 2020	BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (...	BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur...	Class II	Becton Dickinson & Co.
Jul 20, 2020	BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-0...	BD is experiencing elevated rates of potential false positive results from certain customers when...	Class II	Becton Dickinson & Co.
Apr 14, 2020	BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential sta...	May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit...	Class II	Becton Dickinson & Co.
Apr 14, 2020	BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorgan...	May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit...	Class II	Becton Dickinson & Co.
Apr 14, 2020	BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorga...	May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit...	Class II	Becton Dickinson & Co.
Jul 26, 2019	BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing ...	An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a m...	Class II	Becton Dickinson & Co.
Jul 26, 2019	BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing ...	An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a m...	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max MRSA XT; Catalog # 443461	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max ExK DNA 2 USA; Catalog # 442819	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max Enteric Parasite Panel EU; Catalog # 442960	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max GC RT PCR Assay; Catalog # 443486	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max Cdiff EU; Catalog # 442555	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max CT/GC/TV; Catalog # 442970	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max StaphSR; Catalog # 443419	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max Vaginal Panel; Catalog # 443712	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.
Jul 17, 2019	Kit BD Max MRSA; Catalog # 442953	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.	Class II	Becton Dickinson & Co.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.