FDA Device · 2022
FDA Device recalls in 2022
RecallRadar indexes 2,191 FDA Device recall notices published in 2022. By classification: 168 Class I, 1,946 Class II, 77 Class III.
- (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product…
FDA Device · Class II · 2022-07-27 · Smith And Nephew - AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03
FDA Device · Class II · 2022-07-27 · Baxter Healthcare - GreenLight HPSEA Laser Fibers, UPN 0010-2092
FDA Device · Class III · 2022-07-27 · Boston Scientific - Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03
FDA Device · Class II · 2022-07-27 · Baxter Healthcare - BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrop…
FDA Device · Class II · 2022-07-27 · Siemens Medical Solutions Usa - Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - X80 RADiant Photoelectric Therapy System
FDA Device · Class II · 2022-07-27 · Xstrahl - MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - Ambu VivaSight 2 DLT
FDA Device · Class II · 2022-07-27 · Ambu - SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090
FDA Device · Class II · 2022-07-27 · Stryker Instruments Div - AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04
FDA Device · Class II · 2022-07-27 · Baxter Healthcare - AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161
FDA Device · Class III · 2022-07-27 · Randox Laboratories - AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000
FDA Device · Class II · 2022-07-27 · Ge Healthcare - BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
FDA Device · Class III · 2022-07-27 · Stryker Instruments Div - LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
FDA Device · Class II · 2022-07-27 · Coopersurgical - Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01
FDA Device · Class II · 2022-07-27 · Baxter Healthcare - RayStation 9B SP1. For radiation treatment planning
FDA Device · Class II · 2022-07-27 · Raysearch Laboratories Ab - Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - Wright EVOLVE TRIAD Plate Cutter, REF 49510120
FDA Device · Class II · 2022-07-20 · Wright Medical Technology - NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic r…
FDA Device · Class II · 2022-07-20 · Fresenius Medical Care Holdings - MiniMed 740G Insulin Pump (O.U.S. Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed - AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
FDA Device · Class II · 2022-07-20 · Aesculap Implant Systems - MiniMed 720G Insulin Pump (O.U.S. Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed - ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
FDA Device · Class II · 2022-07-20 · Science And Bio Materials - Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis
FDA Device · Class II · 2022-07-20 · Waldemar Link And Kg Mfg Site - DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
FDA Device · Class II · 2022-07-20 · Philips Medical Systems Dmc - Peak Universal Bond Self-Etch Bottle Kit, Part: 4541
FDA Device · Class II · 2022-07-20 · Ultradent Products - NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic r…
FDA Device · Class II · 2022-07-20 · Fresenius Medical Care Holdings - Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
FDA Device · Class II · 2022-07-20 · Spectranetics - PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX
FDA Device · Class II · 2022-07-20 · Cordis Us - Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Device · Class II · 2022-07-20 · Isopure - MiniMed 640G Insulin Pump (O.U.S. Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed - Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical…
FDA Device · Class II · 2022-07-20 · Breas Medical - MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed - MiniMed 620G Insulin Pump (O.U.S. version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed - MiniMed 780G Insulin Pump (O.U.S. Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed - Ivenix Infusion System (IIS)
FDA Device · Class II · 2022-07-20 · Ivenix - Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600…
FDA Device · Class II · 2022-07-20 · Ortho Clinical Diagnostics - Pressure Monitoring Set, Single-lumen uncoated central venous catheter
FDA Device · Class II · 2022-07-20 · Cook - MiniMed 630G Insulin Pump (U.S. and Canada Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed - CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
FDA Device · Class II · 2022-07-20 · Zeltiq Aesthetics - CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
FDA Device · Class II · 2022-07-20 · Zeltiq Aesthetics - MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive
FDA Device · Class II · 2022-07-20 · Depuy Orthopaedics - CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
FDA Device · Class II · 2022-07-20 · Zeltiq Aesthetics - ProxiDiagnost N90. radiography and fluoroscopy system
FDA Device · Class II · 2022-07-20 · Philips Medical Systems Dmc - Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
FDA Device · Class III · 2022-07-20 · Invacare - Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K58991…
FDA Device · Class III · 2022-07-20 · Agilent Technologies - CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
FDA Device · Class II · 2022-07-20 · Zeltiq Aesthetics - MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed - Ventana HE 600 System, automated slide preparer, for use in laboratories
FDA Device · Class II · 2022-07-20 · Ventana Medical Systems - Tibial Component Modular. orthopedic prosthesis
FDA Device · Class II · 2022-07-20 · Waldemar Link And Kg Mfg Site - Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTO…
FDA Device · Class II · 2022-07-20 · Alcon Research - CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
FDA Device · Class II · 2022-07-20 · Zeltiq Aesthetics - AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US…
FDA Device · Class II · 2022-07-20 · Fresenius Medical Care Holdings - epoc BGEM Test Card 25 Test Cards/box
FDA Device · Class II · 2022-07-20 · Siemens Healthcare Diagnostics - Tibial Component. orthopedic prosthesis
FDA Device · Class II · 2022-07-20 · Waldemar Link And Kg Mfg Site - DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
FDA Device · Class II · 2022-07-20 · Philips Medical Systems Dmc - DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
FDA Device · Class II · 2022-07-20 · Philips Medical Systems Dmc - Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthop…
FDA Device · Class II · 2022-07-20 · Waldemar Link And Kg Mfg Site - Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
FDA Device · Class II · 2022-07-20 · Draeger Medical Systems - HAMILTON-H900 Humidifier, Models: 950001, 950004
FDA Device · Class III · 2022-07-20 · Hamilton Medical Ag - DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
FDA Device · Class II · 2022-07-20 · Philips Medical Systems Dmc - Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during abla…
FDA Device · Class II · 2022-07-13 · Abbott - GE Centricity Universal Viewer Zero Footprint
FDA Device · Class II · 2022-07-13 · Ge Healthcare - Omnera 400A Digital Radiographic System
FDA Device · Class II · 2022-07-13 · Arcoma Ab - syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno…
FDA Device · Class II · 2022-07-13 · Siemens Medical Solutions Usa - Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Device · Class II · 2022-07-13 · Siemens Medical Solutions Usa - Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
FDA Device · Class II · 2022-07-13 · Siemens Medical Solutions Usa - RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton lab…
FDA Device · Class II · 2022-07-13 · Rayner Intraocular Lenses - Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to…
FDA Device · Class II · 2022-07-13 · Siemens Healthcare Diagnostics - Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma t…
FDA Device · Class II · 2022-07-13 · Siemens Healthcare Diagnostics - Palindrome Chronic Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - Verigene CDF Nucleic Acid Test, Part No. 30-002-22
FDA Device · Class II · 2022-07-13 · Luminex - ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
FDA Device · Class II · 2022-07-13 · Radiometer Medical Aps - Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
FDA Device · Class II · 2022-07-13 · Chromsystems Instruments And Chemicals - Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
FDA Device · Class II · 2022-07-13 · Fresenius Medical Care Holdings - CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (…
FDA Device · Class II · 2022-07-13 · Menarini Silicon Biosystems - Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only
FDA Device · Class I · 2022-07-13 · Covidien - Omnera 400T Digital Radiographic System
FDA Device · Class II · 2022-07-13 · Arcoma Ab - OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents
FDA Device · Class II · 2022-07-13 · Ossur Americas - VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
FDA Device · Class II · 2022-07-13 · Luminex - EEA Autosuture Circular Stapler with DST Series Technology, 25mm
FDA Device · Class II · 2022-07-13 · Covidien - Clean Catch Urine Kit NS 178489, AHMU58A
FDA Device · Class I · 2022-07-13 · American Contract Systems - EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion i…
FDA Device · Class II · 2022-07-13 · Depuy Spine
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