BEUDAMED
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    THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code OAD·September 7, 2022

    Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code MND·February 23, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510; d. OR CATHETER INSERTION SETUP PACK, Model Number: ECVC7165A; e. VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number: STCVC01145B; f. VANTEX TRIPLE LUMEN BUNDLE, Model Number: STCVC2000;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFD·May 15, 2023

    Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

    FDA Recall
    Open, Classified ·Medtronic, Inc.·Product code OAD·March 11, 2026

    Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number DYNDH1693A; 6) PACK,ULTRASOUND, Pack Number DYNDL1461; 7) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 8) ARTHROGRAM TRAY, Pack Number SPEC0143A; 9) PD CATH KIT, Pack Number UVT1205

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFD·April 8, 2024

    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFD·May 18, 2023

    Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·June 20, 2018

    IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018

    Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code MND·October 30, 2025

    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018

    Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFD·April 8, 2024

    ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device

    FDA Recall
    Open, Classified ·J & T Health and Wellness LLC·Product code LEJ·March 31, 2023

    BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTY·November 21, 2022

    BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010454; BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog # 10013072; BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog # 10013361; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 10013890; BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog # 10015012; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog # 10015862; BD AlarisTM Pump Infusion Blood Set 180 Micron Filter 2 Blunt Spikes, Catalog # 10062818; BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog # 10821753; BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog # 11171447; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 11426964; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog # 11532269; BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog # 11613191; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog # 10015861A; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog # 22000-B007T; BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog # 2202-0007; BD AlarisTM Pump Infusion Set, Catalog # 2204-0007; BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog # 2206-0007; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 2260-0500; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22600-0007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22601-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22602-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22603-B007T; BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog # 24001-0007; BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog # 2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog # 24301-0007T; BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog # 2441-0007; BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog # 2450-0500; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog # 24600-0007; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog # 24601-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog # 2465-0007; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog # 2466-0007.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code FPA·October 11, 2023

    BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code FPA·October 11, 2023

    BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632and 231633

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640and 231641.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in vitro susceptibility testing.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for yeast identification.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code LON·February 29, 2024