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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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DateProductReasonClassFirm
Jul 17, 2019 Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818 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 TNA 2; Catalog # 442825 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 Viral Panel EU Catalog # 443985 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 Check-Points CPO IVD EU; Catalog # 278102 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 EXT Enteric Bacterial Panel; Catalog # 443812 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 1 USA; Catalog # 442817 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 # 443418 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 Viral Panel RUO; Catalog # 443715 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Apr 3, 2019 BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Ve... Background calibration has the potential to cause false positive or false negative test results. ... Class II Becton Dickinson & Co.
Apr 3, 2019 BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System ... Background calibration has the potential to cause false positive or false negative test results. ... Class II Becton Dickinson & Co.
Feb 21, 2019 BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: B... BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect c... Class II Becton Dickinson & Co.
Jan 14, 2019 BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX S... False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically... Class II Becton Dickinson & Co.
Dec 20, 2018 Phoenix AST-s Indicator, Catalog Number 246009 Panels inoculated using certain lots of the indicator solution are demonstrating an increased occ... Class II Becton Dickinson & Co.
Dec 20, 2018 Phoenix AP AST Indicator Bag, Catalog Number 246006 Panels inoculated using certain lots of the indicator solution are demonstrating an increased occ... Class II Becton Dickinson & Co.
Dec 20, 2018 Phoenix AST Indicator, Catalog Number 246004 Panels inoculated using certain lots of the indicator solution are demonstrating an increased occ... Class II Becton Dickinson & Co.
Oct 22, 2018 BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-sele... a portion of a single lot was not manufactured in accordance with the internal formulation result... Class II Becton Dickinson & Co.
Sep 24, 2018 BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 ... A trend for false positive Candida glabrata results has been confirmed. The discrepant results i... Class II Becton Dickinson & Co.
Sep 24, 2018 BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Pr... A trend for false positive Candida glabrata results has been confirmed. The discrepant results i... Class II Becton Dickinson & Co.
Sep 21, 2018 BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos... The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. ... Class III Becton Dickinson & Co.
Jun 21, 2018 BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium pro... A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an i... Class II Becton Dickinson & Co.
Mar 2, 2018 BD MAX DNA MMK Lab Use, catalog no. 442828 The package insert incorrectly lists the volume of the primer and probe diluent to use for the re... Class III Becton Dickinson & Co.
Mar 2, 2018 BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 The package insert incorrectly lists the volume of the primer and probe diluent to use for the re... Class III Becton Dickinson & Co.
Oct 3, 2017 Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is e... HighPuragar was mislabeled and inadvertently sold as Noble Agar. Class II Becton Dickinson & Co.
Jul 18, 2017 BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for colle... BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and i... Class II Becton Dickinson & Co.
Jul 18, 2017 BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collecti... BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and i... Class II Becton Dickinson & Co.
Jul 18, 2017 BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for col... BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and i... Class II Becton Dickinson & Co.
Jun 1, 2017 BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is desi... Potential unexpected movement of robot arm Class III Becton Dickinson & Co.
May 22, 2017 TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 ... Listeria monocytogenes contamination of non-sterile plated media Class II Becton Dickinson & Co.
May 11, 2017 BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)70... BD has recently confirmed quality control failures, related to a manufacturing issue, for the ind... Class II Becton Dickinson & Co.
Jun 1, 2016 PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoeni... BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the fol... Class III Becton Dickinson & Co.
Jun 1, 2016 PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec &#38; Phoenix ... BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following... Class III Becton Dickinson & Co.
Mar 28, 2016 Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar C... Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with L... Class II Becton Dickinson & Co.
Feb 12, 2016 BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, ... BD has confirmed that a portion of BD SurePath" collection vials associated with specific product... Class II Becton Dickinson & Co.
Aug 27, 2015 BD AffirM VPIII Microbial Identification Test BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) o... Class II Becton Dickinson & Co.
Jun 29, 2015 Vancomycin Screen Agar The affected expired lots of product may have exhibited breakthrough growth of vancomycin suscep... Class II Becton Dickinson & Co.
Jun 29, 2015 Enterococcus Screen Agar QUAD Plate The affected expired lots of product may have exhibited breakthrough growth of vancomycin suscep... Class II Becton Dickinson & Co.
Mar 27, 2015 BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (G... BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophil... Class III Becton Dickinson & Co.
Nov 21, 2014 BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes... The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the ... Class II Becton Dickinson & Co.
Nov 21, 2014 BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For pati... The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the ... Class II Becton Dickinson & Co.
Nov 7, 2014 BD Viper LT System, catalog number 442839 when used in conjunction with the B... Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) re... Class II Becton Dickinson & Co.
Aug 25, 2014 EpiCenter Plus Microbiology Data Management System software version 6.20A, wh... The information in the EpiCenter interface translation tables was not updated to match the Bruker... Class II Becton Dickinson & Co.
Jul 28, 2014 BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar... These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus ... Class II Becton Dickinson & Co.
Jul 23, 2014 The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitr... The performance of the assay no longer conforms to this statement in the Analytical Specificity s... Class II Becton Dickinson & Co.
Jun 6, 2014 CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an en... A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... Class II Becton Dickinson & Co.
Jun 6, 2014 Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a g... A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... Class II Becton Dickinson & Co.
Jun 6, 2014 TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar ... A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... Class II Becton Dickinson & Co.
May 21, 2014 BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catal... A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 322... Class III Becton Dickinson & Co.
Dec 9, 2013 BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit ins... Improperly functioning component of a diagnostic medical device may cause false negative results ... Class II Becton Dickinson & Co.
Dec 9, 2013 BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnos... Improperly functioning component of a diagnostic medical device may cause false negative results ... Class II Becton Dickinson & Co.
Oct 11, 2013 BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tube... An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in u... 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.