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.
- ITST THREADED GUIDE PIN
FDA Device · Class II · 2014-01-08 · Zimmer - STERRAD Cyclesure Biological Indicator (BI, Part No. 14324
FDA Device · Class II · 2014-01-08 · Advanced Sterilization Products - Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed b…
FDA Device · Class II · 2014-01-08 · Asante Solutions - DIST LAT FEM LOCK PLT, LT
FDA Device · Class II · 2014-01-08 · Zimmer - Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in w…
FDA Device · Class II · 2014-01-08 · Philips Medical Systems - Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for…
FDA Device · Class II · 2014-01-08 · Philips Medical Systems - Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: s…
FDA Device · Class II · 2014-01-08 · Zimmer - DIST LAT FEM LOCK PLT, RT
FDA Device · Class II · 2014-01-08 · Zimmer - VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation t…
FDA Device · Class II · 2014-01-08 · Steris - Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals
FDA Device · Class II · 2014-01-08 · Stryker Medical Division - Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactur…
FDA Device · Class II · 2014-01-08 · Asante Solutions - FEM COND BUTTRESS PLT, LT
FDA Device · Class II · 2014-01-08 · Zimmer - Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Cam…
FDA Device · Class II · 2014-01-08 · Integra Lifesciences - TIB NAIL
FDA Device · Class II · 2014-01-08 · Zimmer - Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or…
FDA Device · Class II · 2014-01-08 · Zimmer - NGK Stem Ext 24 x 245mm
FDA Device · Class II · 2014-01-08 · Zimmer - Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asa…
FDA Device · Class II · 2014-01-08 · Asante Solutions - Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4)
FDA Device · Class II · 2014-01-08 · Asante Solutions - Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx…
FDA Device · Class II · 2014-01-08 · Philips Medical Systems - CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis
FDA Device · Class II · 2014-01-08 · Zimmer - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class II · 2014-01-08 · Ge Healthcare It - Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature
FDA Device · Class II · 2014-01-08 · Merit Medical Systems - Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4)
FDA Device · Class II · 2014-01-08 · Asante Solutions - Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered
FDA Device · Class II · 2014-01-01 · Spinefrontier - Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System
FDA Device · Class II · 2014-01-01 · Ziehm Imaging - Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System
FDA Device · Class II · 2014-01-01 · Ziehm Imaging - G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
FDA Device · Class II · 2014-01-01 · Biomet - Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System
FDA Device · Class II · 2014-01-01 · Ziehm Imaging - McKesson Radiology 12.0, Picture Archiving Communication System (PACSA)
FDA Device · Class II · 2014-01-01 · Mckesson Information Solutions - Viscocel and Viscocel Plus
FDA Device · Class I · 2014-01-01 · C L R Medicals International - Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery
FDA Device · Class II · 2014-01-01 · Stryker Howmedica Osteonics - Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.0…
FDA Device · Class II · 2014-01-01 · Data Innovations - Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling
FDA Device · Class II · 2014-01-01 · Spinefrontier - PedFuse Reset Screw Inserters
FDA Device · Class II · 2014-01-01 · Spinefrontier - IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD
FDA Device · Class II · 2014-01-01 · Siemens Healthcare Diagnostics - OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation T…
FDA Device · Class II · 2014-01-01 · Orthopediatrics - ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use On…
FDA Device · Class II · 2014-01-01 · Materialise Usa - HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT…
FDA Device · Class II · 2014-01-01 · Abbott Vascular - Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13
FDA Device · Class II · 2014-01-01 · Varian Medical Systems - Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip
FDA Device · Class III · 2014-01-01 · Edwards Lifesciences - REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc
FDA Device · Class II · 2014-01-01 · Smith And Nephew - Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in s…
FDA Device · Class II · 2014-01-01 · Clark Laboratories Dba Trinity Biotech Usa - PedFuse Reset Screw Inserters
FDA Device · Class II · 2014-01-01 · Spinefrontier - Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System
FDA Device · Class II · 2014-01-01 · Ziehm Imaging - Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular ta…
FDA Device · Class II · 2014-01-01 · Philips Medical Systems - Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System
FDA Device · Class II · 2014-01-01 · Ziehm Imaging - Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterog…
FDA Device · Class II · 2014-01-01 · Siemens Healthcare Diagnostics - Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600
FDA Device · Class I · 2014-01-01 · Carefusion 303 - VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
FDA Device · Class II · 2014-01-01 · Ortho Clinical Diagnostics - Integra Cranial Access Kit, Model Number HITHSP10, Rx Only
FDA Device · Class II · 2014-01-01 · Integra Lifesciences D B A Integra Pain Management - Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping
FDA Device · Class II · 2014-01-01 · Spinefrontier - Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery
FDA Device · Class II · 2014-01-01 · Stryker Howmedica Osteonics - Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System
FDA Device · Class II · 2014-01-01 · Ziehm Imaging - Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System
FDA Device · Class II · 2014-01-01 · Ziehm Imaging - steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is…
FDA Device · Class II · 2014-01-01 · Eos Imaging - ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx o…
FDA Device · Class II · 2014-01-01 · Materialise Usa - PedFuse Reset Screw Inserters
FDA Device · Class II · 2014-01-01 · Spinefrontier - Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling
FDA Device · Class II · 2014-01-01 · Spinefrontier - B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02
FDA Device · Class II · 2014-01-01 · B Braun Medical
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