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.
- Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc…
FDA Device · Class III · 2018-02-28 · Livanova Usa - Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software…
FDA Device · Class II · 2018-02-28 · Fujifilm Medical Systems U - Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features
FDA Device · Class II · 2018-02-28 · Arrow International - Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended t…
FDA Device · Class II · 2018-02-28 · Medtronic - CVC Tray Pediatrics
FDA Device · Class II · 2018-02-28 · Vygon Mfg Dba Churchill Medical Systems - Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, t…
FDA Device · Class II · 2018-02-28 · Covidien - Philips QCPR Meter - used with FR3 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 - Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
FDA Device · Class II · 2018-02-28 · Hologic - Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
FDA Device · Class III · 2018-02-28 · Ivoclar Vivadent - Innova Self-Expanding Stent System, 200 mm
FDA Device · Class II · 2018-02-28 · Boston Scientific - Nutrisafe 2 35 mL Syringe for Safety Connection
FDA Device · Class II · 2018-02-28 · Vygon Mfg Dba Churchill Medical Systems - CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
FDA Device · Class II · 2018-02-21 · Depuy Orthopaedics - Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentu…
FDA Device · Class II · 2018-02-21 · Keystone Dental - NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the…
FDA Device · Class II · 2018-02-21 · Aesculap Implant Systems - Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan…
FDA Device · Class II · 2018-02-21 · Sanofi Genzyme - ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 E…
FDA Device · Class II · 2018-02-21 · Aesculap Implant Systems - Spinal & Epidural Anesthesia Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove mat…
FDA Device · Class II · 2018-02-21 · Zimmer Biomet - ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL…
FDA Device · Class II · 2018-02-21 · Aesculap Implant Systems - Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
FDA Device · Class II · 2018-02-21 · Medtronic Sofamor Danek Usa - Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
FDA Device · Class II · 2018-02-21 · Orthopediatrics - ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A
FDA Device · Class II · 2018-02-21 · Arrow International - Perifix Epidural AnesthesiaTray
FDA Device · Class II · 2018-02-21 · B Braun Medical - AVID Medical QA Pack AV10654-10
FDA Device · Class II · 2018-02-21 · Avid Medical - The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Sur…
FDA Device · Class II · 2018-02-21 · Aesculap Implant Systems - Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN numb…
FDA Device · Class II · 2018-02-21 · Roche Diabetes Care - Video Cystoscope models ECY-1570 and ECY-1570K
FDA Device · Class II · 2018-02-21 · Pentax - Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrum…
FDA Device · Class II · 2018-02-21 · Hologic - Contiplex Nerve Block Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - Norian Drillable Inject
FDA Device · Class II · 2018-02-21 · Synthes Usa - Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to oth…
FDA Device · Class II · 2018-02-21 · Arrow International - EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
FDA Device · Class II · 2018-02-21 · Little Rapids - CORAIL HIGH OFFSET STEM Collarless SIZE 14
FDA Device · Class II · 2018-02-21 · Depuy Orthopaedics - Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is…
FDA Device · Class II · 2018-02-21 · Cook - 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
FDA Device · Class II · 2018-02-21 · Synthes Usa Products - Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is design…
FDA Device · Class II · 2018-02-21 · Cook - Customer Epidural Anesthesia Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
FDA Device · Class II · 2018-02-21 · Ge Medical Systems China - Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emissio…
FDA Device · Class II · 2018-02-21 · Philips Medical Systems Cleveland - Pencan Spinal Needle Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf ca…
FDA Device · Class II · 2018-02-21 · Kalila Medical - BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor…
FDA Device · Class II · 2018-02-21 · C R Bard - Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation…
FDA Device · Class II · 2018-02-21 · Zimmer Biomet - Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT…
FDA Device · Class II · 2018-02-21 · Cepheid - Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/…
FDA Device · Class II · 2018-02-21 · Conformis - Perifix Continuous Epidural Anesthesia Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is inten…
FDA Device · Class II · 2018-02-21 · 3m Health Care Business - PENCAN Spinal Anesthesia Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is…
FDA Device · Class II · 2018-02-21 · 3m Health Care Business - JS Series SterilContainer S2 System
FDA Device · Class II · 2018-02-21 · Aesculap Implant Systems - ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO…
FDA Device · Class II · 2018-02-21 · Aesculap Implant Systems - Purely Yours Breast Pump
FDA Device · Class III · 2018-02-21 · Ameda - AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802
FDA Device · Class II · 2018-02-21 · Zimmer Biomet - A.T.S. 2200TS Tourniquet Systems, Personalized Pressure
FDA Device · Class II · 2018-02-21 · Zimmer Surgical - Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
FDA Device · Class II · 2018-02-21 · Exactech - ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
FDA Device · Class II · 2018-02-21 · Arrow International - Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens
FDA Device · Class II · 2018-02-21 · Gibson Laboratories - Artis oneFloor-mounted system for uncompromised imaging
FDA Device · Class II · 2018-02-21 · Siemens Medical Solutions Usa - A.T.S. 4000TS Tourniquet Systems, Personalized Pressure
FDA Device · Class II · 2018-02-21 · Zimmer Surgical - Perifix FX Epidural Anesthesia Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods…
FDA Device · Class II · 2018-02-21 · Beckman Coulter - Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infus…
FDA Device · Class II · 2018-02-21 · Smiths Medical Asd - Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that sup…
FDA Device · Class II · 2018-02-21 · Cincinnati Sub Zero Products - Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile,…
FDA Device · Class II · 2018-02-21 · Kalila Medical - Perifix Single Dose Epidural Anesthesia Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - Norian Drillable Inject
FDA Device · Class II · 2018-02-21 · Synthes Usa - Pain Management Tray
FDA Device · Class II · 2018-02-21 · B Braun Medical - G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and…
FDA Device · Class II · 2018-02-21 · Zimmer Biomet - Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Produc…
FDA Device · Class II · 2018-02-21 · Cook - Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1)
FDA Device · Class II · 2018-02-21 · Medtronic Neurosurgery - Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is des…
FDA Device · Class II · 2018-02-21 · Cook - Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLM…
FDA Device · Class II · 2018-02-21 · Cook - Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA Device · Class II · 2018-02-21 · Ge Medical Systems China - AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804
FDA Device · Class II · 2018-02-21 · Zimmer Biomet - Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Tip and T…
FDA Device · Class II · 2018-02-14 · Zimmer Biomet - ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2
FDA Device · Class II · 2018-02-14 · 3m Health Care Business - Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UD…
FDA Device · Class III · 2018-02-14 · Medtronic Neuromodulation - Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V…
FDA Device · Class II · 2018-02-14 · Angiodynamics - Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
FDA Device · Class II · 2018-02-14 · Implant Direct Sybron Manufacturing - Disposable Light Handle Cover, Item Number B1-715-65
FDA Device · Class II · 2018-02-14 · Ecolab - AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications fo…
FDA Device · Class II · 2018-02-14 · Brainlab Ag - Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon…
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a…
FDA Device · Class II · 2018-02-14 · Angiodynamics - TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
FDA Device · Class II · 2018-02-14 · Mindray Ds Usa - Philips Ingenuity Core computed tomography x-ray system
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
FDA Device · Class II · 2018-02-14 · Covidien - Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection…
FDA Device · Class II · 2018-02-14 · Spacelabs Healthcare - Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon…
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and inte…
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product U…
FDA Device · Class II · 2018-02-14 · Zimmer Biomet - Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
FDA Device · Class II · 2018-02-14 · Covidien - Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplan…
FDA Device · Class II · 2018-02-14 · Siemens Medical Solutions Usa - BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imagi…
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Philips Ingenuity Core 128 computed tomography x-ray system
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Philips Ingenuity CT computed tomography x-ray system
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen
FDA Device · Class II · 2018-02-14 · Bard Access Systems
Other years
2026 (2,088) · 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)