FDA (Device enforcement)

11,102 recalls · page 86 of 112

• Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 7181322021-11-12
• Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG2021-11-12
• Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C2021-11-12
• Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP2021-11-12
• Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 7222242021-11-12
• SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 4678252021-11-10
• PIVO Blood Collection Device 20G, REF: 202-00052021-11-10
• Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).2021-11-08
• Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M722021-11-08
• Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator2021-11-08
• QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 6912232021-11-08
• Puritan Bennett 980 Series Ventilator, 980A1ENNISB2021-11-04
• Puritan Bennett 980 Series Ventilator, 980S1ENDICU2021-11-04
• Puritan Bennett 980 Series Ventilator, 980S3ENDICU2021-11-04
• Puritan Bennett 980 Series Ventilator, 980U1ENASAA2021-11-04
• Puritan Bennett 980 Series Ventilator, 980X1ENDIUU2021-11-04
• Puritan Bennett 980 Series Ventilator, 980X1ENNISB2021-11-04
• Puritan Bennett 980 Series Ventilator, 980X1JADIJJ2021-11-04
• Puritan Bennett 980 Series Ventilator, 980X3ENDIUU2021-11-04
• Puritan Bennett 980 Series Ventilator, 980X3JADIJJ2021-11-04
• FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test2021-11-04
• Leica Microsystems M220 F12 Microscope Systems2021-11-03
• The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Ge2021-11-02
• SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 324742021-11-02
• SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 90112021-11-02
• SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 90412021-11-02
• SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL2021-11-02
• Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 90102021-11-02
• Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 90402021-11-02
• Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 90702021-11-02
• RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 95182021-11-02
• RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 95482021-11-02
• RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 95782021-11-02
• RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 959982021-11-02
• Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-12021-11-02
• smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 725731012021-11-01
• Hanger-Bar 2P 45cm2021-11-01
• Hanger-Bar 2P 45cm2021-11-01
• NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP, 2021-10-29
• Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028,2021-10-29
• OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power 2021-10-28
• Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.2021-10-28
• Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.2021-10-25
• The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporate2021-10-22
• HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005458902021-10-21
• HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005459002021-10-21
• HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M005459102021-10-21
• HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005459202021-10-21
• HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005459302021-10-21
• HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005459402021-10-21
• HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005459502021-10-21
• HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005459602021-10-21
• CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 7090312021-10-21
• ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 7061102021-10-21
• Model B35200 - Percept PC BrainSense Implantable Neurostimulator2021-10-19
• Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP2021-10-19
• VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems2021-10-15
• Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S2021-10-15
• Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE2021-10-15
• Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF22021-10-15
• Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT 2021-10-15
• GE Centricity Universal Viewer Zero Footprint Client2021-10-15
• Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)2021-10-15
• Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)2021-10-15
• Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.32021-10-14
• Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.32021-10-14
• Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.32021-10-14
• Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.02021-10-14
• SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use o2021-10-14
• These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 20202021-10-14
• MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 7120072021-10-14
• Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-002021-10-13
• HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.2021-10-13
• Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.2021-10-13
• Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model 2021-10-12
• Artis pheno with software VE20C- diagnostic imaging angiography system Model: 108490002021-10-12
• Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 113276002021-10-12
• Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 113277002021-10-12
• GM Helix Acqua Implant 3.5x10, Article No. 140.9442021-10-11
• BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 42021-10-11
• Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.2021-10-08
• Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle2021-10-08
• Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 3738092021-10-08
• bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 3738092021-10-08
• VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX2021-10-08
• VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX2021-10-08
• VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX2021-10-08
• VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX2021-10-08
• 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring E2021-10-06
• Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis2021-10-05
• MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured 2021-09-30
• Hemodialysis Delivery System, Software Version 2.x.2021-09-29
• ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C892021-09-29
• ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;2021-09-29
• Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.2021-09-28
• Cardioblate CryoFlex Surgical Ablation Console2021-09-27
• HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL2021-09-27
• Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, A2021-09-24
• Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 112078612021-09-22
• ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 112078662021-09-22