BEUDAMED
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    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019

    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code CCW·November 27, 2019

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019

    EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OAE·November 22, 2010

    EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OAE·November 22, 2010

    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OCC·October 10, 2013

    Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.

    FDA Recall
    Terminated ·Abbott·Product code OAE·May 22, 2020

    EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OAE·November 22, 2010

    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OAE·March 19, 2015

    Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests

    FDA Recall
    Terminated ·Quidel Corporation·Product code OCC·January 25, 2017

    cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OCC·May 17, 2016

    Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code OCC·January 10, 2014

    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.

    FDA Recall
    Terminated ·Alere Scarborough, Inc. dba Binax, Inc.·Product code OCC·June 26, 2015

    Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code OCC·May 15, 2014

    EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code OAE·November 22, 2010

    TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.

    FDA Recall
    Terminated ·Product code OAE·November 25, 2014

    cobas Liat Analyzer, for in vitro diagnostic use.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OCC·July 24, 2015

    cobas Liat Analyzer

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OCC·May 9, 2016