FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- Rusch Greenlite MAC 1, Catalog Number 004551001
FDA Device · Class II · 2018-03-07 · Teleflex Medical - Agility with Integrity R3.2
FDA Device · Class II · 2018-03-07 · Elekta - Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body co…
FDA Device · Class II · 2018-03-07 · Lifecell A Wholly Owned Subsidiary - MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless…
FDA Device · Class II · 2018-03-07 · Zevex Dba Moog Medical Medical Devices Group - AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03
FDA Device · Class II · 2018-03-07 · Avid Medical - V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
FDA Device · Class II · 2018-03-07 · Steris - Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used…
FDA Device · Class II · 2018-03-07 · Terumo Medical - ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
FDA Device · Class II · 2018-03-07 · Avid Medical - BC Thrombin Reagent Kit Lot Number 46751
FDA Device · Class II · 2018-03-07 · Siemens Healthcare Diagnostics - Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 772…
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips P…
FDA Device · Class II · 2018-03-07 · Philips Electronics North America - VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600…
FDA Device · Class III · 2018-03-07 · Ortho Clinical Diagnostics - AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
FDA Device · Class II · 2018-03-07 · Avid Medical - ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy p…
FDA Device · Class II · 2018-03-07 · Alcon Research - Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
FDA Device · Class II · 2018-03-07 · Avid Medical - Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015)
FDA Device · Class II · 2018-03-07 · Angiodynamics - Coated VICRYL RAPIDETM (Polyglactin 910) Suture
FDA Device · Class II · 2018-03-07 · Ethicon - AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
FDA Device · Class II · 2018-03-07 · Avid Medical - Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy
FDA Device · Class II · 2018-03-07 · Fresenius Medical Care Renal Therapies Group - Vis-U-All High Temperature Tubing 14"x100'. One roll per box
FDA Device · Class II · 2018-03-07 · Steris - AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
FDA Device · Class II · 2018-03-07 · Avid Medical - Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoul…
FDA Device · Class II · 2018-03-07 · Depuy Orthopaedics - Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC C…
FDA Device · Class II · 2018-03-07 · Philips Electronics North America - CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
FDA Device · Class I · 2018-03-07 · Ventana Medical Systems - Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORK…
FDA Device · Class II · 2018-03-07 · Oakworks - 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers…
FDA Device · Class II · 2018-03-07 · Depuy Mitek A Johnson And Johnson - Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
FDA Device · Class II · 2018-03-07 · Baxter Healthcare - Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2018-03-07 · Steris - Truth Renew
FDA Device · Class II · 2018-03-07 · Accord Media - AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02
FDA Device · Class II · 2018-03-07 · Avid Medical - MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully pla…
FDA Device · Class II · 2018-03-07 · Medistim Asa - ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
FDA Device · Class II · 2018-03-07 · Tosoh Bioscience - AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
FDA Device · Class II · 2018-03-07 · Avid Medical - SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-se…
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
FDA Device · Class II · 2018-03-07 · Avid Medical - Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355
FDA Device · Class II · 2018-03-07 · Siemens Medical Solutions Usa - A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W
FDA Device · Class II · 2018-03-07 · Olympus - Versys 6 inch Beaded Full Coat Plus Hip Prosthesis
FDA Device · Class II · 2018-03-07 · Zimmer Biomet - Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Ven…
FDA Device · Class II · 2018-02-28 · Medtronic Perfusion Systems - Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3…
FDA Device · Class II · 2018-02-28 · Cosman Medical - PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-…
FDA Device · Class II · 2018-02-28 · Merit Medical Systems - Multi Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-02-28 · Arrow International - Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
FDA Device · Class II · 2018-02-28 · Philips Consumer Lifestyle - Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features
FDA Device · Class II · 2018-02-28 · Arrow International - Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
FDA Device · Class II · 2018-02-28 · Deroyal Industries - NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty
FDA Device · Class II · 2018-02-28 · Zimmer Orthopedic Mfg - Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1)
FDA Device · Class I · 2018-02-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - AGB+ Multi Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-02-28 · Arrow International - Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1)
FDA Device · Class I · 2018-02-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatr…
FDA Device · Class II · 2018-02-28 · Covidien - Allen Medical Bow Frame Model A-70800
FDA Device · Class II · 2018-02-28 · Allen Medical Systems - Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-02-28 · Arrow International - ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
FDA Device · Class II · 2018-02-28 · Arrow International - Radiolucent Surgery Spine Frame (F70801)
FDA Device · Class II · 2018-02-28 · Allen Medical Systems - Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
FDA Device · Class II · 2018-02-28 · Hologic - Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva
FDA Device · Class I · 2018-02-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Implantable Cardioverter Defibrillators (ICDs), Evera
FDA Device · Class I · 2018-02-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions
FDA Device · Class II · 2018-02-28 · Arrow International - Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DV…
FDA Device · Class I · 2018-02-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device
FDA Device · Class II · 2018-02-28 · Zimmer Biomet - Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features
FDA Device · Class II · 2018-02-28 · Arrow International - Central Venous Catheterization Kit with Blue FlexTip Catheter
FDA Device · Class II · 2018-02-28 · Arrow International - 20Ga x .75 LifeGuard Huber Needle with Y-site
FDA Device · Class II · 2018-02-28 · Vygon Mfg Dba Churchill Medical Systems - Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical…
FDA Device · Class II · 2018-02-28 · Pentax - Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, a…
FDA Device · Class II · 2018-02-28 · Ethicon Endo Surgery - Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1…
FDA Device · Class I · 2018-02-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter)
FDA Device · Class II · 2018-02-28 · Arrow International - Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
FDA Device · Class III · 2018-02-28 · Ivoclar Vivadent - Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and…
FDA Device · Class II · 2018-02-28 · Innovasis - Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated exter…
FDA Device · Class II · 2018-02-28 · Philips Electronics North America - Cobas 8000 Modular Series system
FDA Device · Class II · 2018-02-28 · Roche Diagnostics - Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
FDA Device · Class II · 2018-02-28 · Zimmer Biomet - Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR M…
FDA Device · Class II · 2018-02-28 · Fujifilm Medical Systems U - LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small…
FDA Device · Class II · 2018-02-28 · Synthes - ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mam…
FDA Device · Class II · 2018-02-28 · Fujifilm Medical Systems U - Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter…
FDA Device · Class II · 2018-02-28 · Medtronic Perfusion Systems - Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthrop…
FDA Device · Class II · 2018-02-28 · Zimmer Biomet - Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1…
FDA Device · Class I · 2018-02-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - 3-Way Standardbore Stopcock
FDA Device · Class II · 2018-02-28 · Vygon Mfg Dba Churchill Medical Systems - Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6…
FDA Device · Class II · 2018-02-28 · Med Tec - Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1…
FDA Device · Class I · 2018-02-28 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography imag…
FDA Device · Class II · 2018-02-28 · Fujifilm Medical Systems U - ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device
FDA Device · Class II · 2018-02-28 · Zimmer Biomet - Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
FDA Device · Class III · 2018-02-28 · Ivoclar Vivadent - 19Ga x 1 Huber Needle Set
FDA Device · Class II · 2018-02-28 · Vygon Mfg Dba Churchill Medical Systems - OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13
FDA Device · Class II · 2018-02-28 · Oculus Optikgeraete - Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
FDA Device · Class III · 2018-02-28 · Ivoclar Vivadent - Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-02-28 · Arrow International - Innova Self-Expanding Stent System, 180mm
FDA Device · Class II · 2018-02-28 · Boston Scientific - Arrow Multi Lumen CVC Kit (Central venous catheter)
FDA Device · Class II · 2018-02-28 · Arrow International - Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2018-02-28 · Arrow International
Other years
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