FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids
FDA Device · Class III · 2014-08-06 · Siemens Healthcare Diagnostics - MC-500 Multicolor Laser Photocoagulator
FDA Device · Class II · 2014-08-06 · Nidek - Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a produ…
FDA Device · Class II · 2014-08-06 · Novocol - Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve…
FDA Device · Class II · 2014-08-06 · Mckesson Medical Immaging - Medtronic Nexdrive Micropositioning Drive
FDA Device · Class II · 2014-08-06 · Medtronic Neuromodulation - Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX"…
FDA Device · Class II · 2014-08-06 · Small Bone Innovations - Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox
FDA Device · Class II · 2014-08-06 · Brainlab Ag - DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc
FDA Device · Class II · 2014-08-06 · Deroyal Industries - FlowCOUPLER. An implantable device that is used to detect blood flow in vessels
FDA Device · Class II · 2014-08-06 · Baxter Healthcare - IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing
FDA Device · Class I · 2014-08-06 · Wellspring Pharmaceutical - Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only)
FDA Device · Class II · 2014-08-06 · Zimmer - PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
FDA Device · Class II · 2014-08-06 · Ra Medical Systems - CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporatio…
FDA Device · Class II · 2014-08-06 · Dynarex - DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc
FDA Device · Class II · 2014-08-06 · Deroyal Industries - InTouch Critical Care Bed, Stryker Medical
FDA Device · Class II · 2014-08-06 · Stryker Medical Division - Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical
FDA Device · Class II · 2014-08-06 · Teleflex Medical - Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heate…
FDA Device · Class II · 2014-07-30 · Teleflex Medical - Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product U…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery
FDA Device · Class III · 2014-07-30 · Zoll Circulation - Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use
FDA Device · Class II · 2014-07-30 · Teleflex Medical - QLAB 10.1 Core Module PN 453561728001
FDA Device · Class II · 2014-07-30 · Philips Ultrasound - Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit
FDA Device · Class II · 2014-07-30 · Exactech - GE Healthcare, CARESCAPE Monitor B850, B650 or B450
FDA Device · Class II · 2014-07-30 · Ge Healthcare - ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are u…
FDA Device · Class I · 2014-07-30 · Diabetic Supply - Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System)
FDA Device · Class II · 2014-07-30 · Synthes - MK5 NX Controller--Wheelchair controller
FDA Device · Class II · 2014-07-30 · Invacare - EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fib…
FDA Device · Class II · 2014-07-30 · Pentax Medical - Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage:…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to displ…
FDA Device · Class II · 2014-07-30 · Siemens Medical Solutions Usa - RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes
FDA Device · Class II · 2014-07-30 · Depuy Orthopaedics - Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The V…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip
FDA Device · Class II · 2014-07-30 · Stryker Endoscopy - GE Healthcare, CARESCAPE Monitor B650
FDA Device · Class II · 2014-07-30 · Ge Healthcare - Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the…
FDA Device · Class II · 2014-07-30 · Perouse Medical - Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of t…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449
FDA Device · Class II · 2014-07-30 · Siemens Healthcare Diagnostics - Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic S…
FDA Device · Class II · 2014-07-30 · Salter Labs - RECLAIM DISTAL TAPERED Distal Stem, various sizes
FDA Device · Class II · 2014-07-30 · Depuy Orthopaedics - Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is ind…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aort…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette
FDA Device · Class II · 2014-07-30 · Itc Nexus Dx - RECLAIM Taper Protector Sleeve
FDA Device · Class II · 2014-07-30 · Depuy Orthopaedics - Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10
FDA Device · Class II · 2014-07-30 · Alphatec Spine - DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC…
FDA Device · Class I · 2014-07-30 · Ge Healthcare - Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: T…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusi…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator…
FDA Device · Class II · 2014-07-30 · Heartsine Technologies - CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannu…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physi…
FDA Device · Class II · 2014-07-30 · Agfa - QLAB 10 Core Module PN 453561704771
FDA Device · Class II · 2014-07-30 · Philips Ultrasound - Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Re…
FDA Device · Class II · 2014-07-30 · Terumo Cardiovascular Systems - InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use
FDA Device · Class II · 2014-07-30 · Biogenex Laboratories - BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and…
FDA Device · Class II · 2014-07-23 · Stryker Communications - Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional
FDA Device · Class II · 2014-07-23 · Axcentria Pharmaceuticals - ACL TOP 700 LAS, automated coagulation laboratory instrument
FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory - Symbia E camera system
FDA Device · Class II · 2014-07-23 · Siemens Medical Solutions Usa - Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm
FDA Device · Class II · 2014-07-23 · Innovasis - Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile
FDA Device · Class II · 2014-07-23 · Pioneer Surgical Technology - Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09)
FDA Device · Class II · 2014-07-23 · Spacelabs Healthcare - SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supp…
FDA Device · Class II · 2014-07-23 · Stryker Communications - BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and…
FDA Device · Class II · 2014-07-23 · Stryker Communications - SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
FDA Device · Class II · 2014-07-23 · Smith And Nephew Endoscopy Division - Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set
FDA Device · Class II · 2014-07-23 · Excelsior Medical - SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
FDA Device · Class II · 2014-07-23 · Smith And Nephew Endoscopy Division - LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery an…
FDA Device · Class II · 2014-07-23 · Laser Peripherals - ACL TOP 300 CTS, automated coagulation laboratory instrument
FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory - ACL TOP CTS, automated coagulation laboratory instrument
FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory - Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation
FDA Device · Class II · 2014-07-23 · Baxter Healthcare - Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat
FDA Device · Class II · 2014-07-23 · Integra Lifesciences - Siemens RAPIDComm¿ Data Management System
FDA Device · Class III · 2014-07-23 · Siemens Healthcare Diagnostics - Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use
FDA Device · Class II · 2014-07-23 · Terumo Cardiovascular Systems - SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
FDA Device · Class II · 2014-07-23 · Smith And Nephew Endoscopy Division - SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
FDA Device · Class II · 2014-07-23 · Smith And Nephew Endoscopy Division - Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device
FDA Device · Class II · 2014-07-23 · Terumo Cardiovascular Systems - Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device
FDA Device · Class II · 2014-07-23 · Terumo Cardiovascular Systems - V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc
FDA Device · Class II · 2014-07-23 · Mindray Ds Usa - ACL TOP 700 CTS, automated coagulation laboratory instrument
FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory - e.cam camera system
FDA Device · Class II · 2014-07-23 · Siemens Medical Solutions Usa - Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
FDA Device · Class II · 2014-07-23 · Zimmer - Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linea…
FDA Device · Class II · 2014-07-23 · Siemens Medical Solutions Usa - ACL TOP 700, automated coagulation laboratory instrument
FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory - Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
FDA Device · Class II · 2014-07-23 · Mti Precision Products - SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and po…
FDA Device · Class II · 2014-07-23 · Stryker Communications - ACL TOP 500 CTS, automated coagulation laboratory instrument
FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory - Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
FDA Device · Class II · 2014-07-23 · Siemens Healthcare Diagnostics - SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and posi…
FDA Device · Class II · 2014-07-23 · Stryker Communications - SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
FDA Device · Class II · 2014-07-23 · Smith And Nephew Endoscopy Division - Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel…
FDA Device · Class II · 2014-07-23 · Remel - ACL TOP (Base), automated coagulation laboratory instrument
FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory - BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of…
FDA Device · Class III · 2014-07-23 · Becton Dickinson And - Shape HF Cardiopulmonary System
FDA Device · Class II · 2014-07-23 · Shape Medical Systems - Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries…
FDA Device · Class II · 2014-07-23 · Dental Ez Group Star Dental Division - GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150
FDA Device · Class II · 2014-07-16 · Hospira - Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system
FDA Device · Class II · 2014-07-16 · Intuitive Surgical - 3M Attest Auto-reader
FDA Device · Class II · 2014-07-16 · 3m Health Care Business - Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor
FDA Device · Class II · 2014-07-16 · Teleflex Medical - Amerigel Wound Dressing 55 gallons/drum
FDA Device · Class II · 2014-07-16 · Kova Laboratories
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)