FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids i…
FDA Device · Class II · 2017-08-16 · International Medsurg Connection - PALLAS M/MAXIMIS 7.5 x 50mm screw
FDA Device · Class II · 2017-08-16 · Valorem Surgical - Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw…
FDA Device · Class II · 2017-08-16 · International Medsurg Connection - Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids in…
FDA Device · Class II · 2017-08-16 · International Medsurg Connection - Piston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or withdraw fluids from the body
FDA Device · Class II · 2017-08-16 · International Medsurg Connection - Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdr…
FDA Device · Class II · 2017-08-16 · International Medsurg Connection - PALLAS M/MAXIMIS Closed Extension
FDA Device · Class II · 2017-08-16 · Valorem Surgical - PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm
FDA Device · Class II · 2017-08-16 · Valorem Surgical - Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the…
FDA Device · Class II · 2017-08-09 · Ortho Solutions - SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument
FDA Device · Class II · 2017-08-09 · Hologic - SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41
FDA Device · Class II · 2017-08-09 · Sentinel Ch Spa - Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
FDA Device · Class II · 2017-08-09 · Stryker Neurovascular - NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
FDA Device · Class II · 2017-08-09 · Greatbatch Medical - NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neu…
FDA Device · Class II · 2017-08-09 · Zimmer Biomet - SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained
FDA Device · Class II · 2017-08-09 · Soft Computer Consultants - SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001
FDA Device · Class II · 2017-08-09 · Stryker Neurovascular - GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
FDA Device · Class II · 2017-08-09 · Ge Inspection Technologies - Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve)
FDA Device · Class II · 2017-08-09 · Greatbatch Medical - Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 1…
FDA Device · Class II · 2017-08-09 · Stryker Neurovascular - SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, incl…
FDA Device · Class II · 2017-08-09 · Spectranetics - Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
FDA Device · Class II · 2017-08-09 · Stryker Neurovascular - OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F
FDA Device · Class II · 2017-08-09 · Xintec - NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence
FDA Device · Class II · 2017-08-09 · Olympus Scientific Solutions Americas - Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 1…
FDA Device · Class II · 2017-08-09 · In2bones Sas - SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
FDA Device · Class II · 2017-08-09 · Myelotec - SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vi…
FDA Device · Class II · 2017-08-09 · Quidel - SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
FDA Device · Class II · 2017-08-09 · Sorin Group Usa - Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape…
FDA Device · Class II · 2017-08-02 · Cardinal Health 200 - STOCKERT Heater-Cooler System 3T, 120V/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - STOCKERT Heater-Cooler System 3T, 240V/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD
FDA Device · Class II · 2017-08-02 · Fisher Diagnostics - STOCKERT Heater-Cooler System 3T, 127V/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessor…
FDA Device · Class II · 2017-08-02 · Cardinal Health 200 - Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD
FDA Device · Class II · 2017-08-02 · Fisher Diagnostics - CS 100 Intra-Aortic Balloon Pump
FDA Device · Class I · 2017-08-02 · Maquet Datascope Cardiac Assist Division - Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide
FDA Device · Class II · 2017-08-02 · Smiths Medical Asd - DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula
FDA Device · Class II · 2017-08-02 · Medtronic Perfusion Systems - DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmo…
FDA Device · Class II · 2017-08-02 · Medtronic Perfusion Systems - CS 100i Intra-Aortic Balloon Pump
FDA Device · Class I · 2017-08-02 · Maquet Datascope Cardiac Assist Division - DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmona…
FDA Device · Class II · 2017-08-02 · Medtronic Perfusion Systems - DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
FDA Device · Class II · 2017-08-02 · Medtronic Perfusion Systems - STOCKERT Heater-Cooler System 3T, 208V/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
FDA Device · Class II · 2017-08-02 · Konica Minolta - VITEK 2 Gram Negative test kits containing colistin (cs01n)
FDA Device · Class II · 2017-08-02 · Biomerieux - PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and tra…
FDA Device · Class III · 2017-08-02 · Perkinelmer Health Sciences - CS 300 Intra-Aortic Balloon Pump
FDA Device · Class I · 2017-08-02 · Maquet Datascope Cardiac Assist Division - INVUITY(R) PhotonBlade(TM), REF PB1
FDA Device · Class II · 2017-08-02 · Invuity - STOCKERT Heater-Cooler System 3T, 230 V
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - Atrium iCAST Balloon Expandable Covered Stent
FDA Device · Class II · 2017-08-02 · Atrium Medical - STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
FDA Device · Class II · 2017-08-02 · Sorin Group Usa - Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1)…
FDA Device · Class II · 2017-08-02 · Medtronic Navigation - DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion
FDA Device · Class II · 2017-08-02 · Medtronic Perfusion Systems - Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to…
FDA Device · Class I · 2017-07-26 · Penumbra - 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display,…
FDA Device · Class II · 2017-07-26 · Pentax - BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for gen…
FDA Device · Class II · 2017-07-26 · Becton Dickinson And - 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video…
FDA Device · Class II · 2017-07-26 · Pentax - BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is…
FDA Device · Class II · 2017-07-26 · Becton Dickinson And - Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
FDA Device · Class II · 2017-07-26 · Draegar Medical Systems - BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration…
FDA Device · Class II · 2017-07-26 · Becton Dickinson And - Install CD, Spine tools, Plus and S7, Version 25
FDA Device · Class II · 2017-07-26 · Medtronic Navigation - MAKO RIO Standard System, internal cPCI Card CageP/N: 201337
FDA Device · Class II · 2017-07-26 · Mako Surgical - BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for gene…
FDA Device · Class II · 2017-07-26 · Becton Dickinson And - BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
FDA Device · Class II · 2017-07-26 · Becton Dickinson And - Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic ima…
FDA Device · Class II · 2017-07-26 · Siemens Medical Solutions Usa - BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals f…
FDA Device · Class II · 2017-07-26 · Becton Dickinson And - Standex International Bakers Pride Microwave Ovens Model E300
FDA Device · Class II · 2017-07-26 · Standex Intl - 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryng…
FDA Device · Class II · 2017-07-26 · Pentax - Agfa Healthcare NX 3.0.8950 Imaging Processing Software
FDA Device · Class II · 2017-07-26 · Agfa Healthcare - BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syring…
FDA Device · Class II · 2017-07-26 · Becton Dickinson And - 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video dat…
FDA Device · Class II · 2017-07-26 · Pentax - PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02
FDA Device · Class II · 2017-07-26 · Flowonix Medical - Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration o…
FDA Device · Class II · 2017-07-26 · Merge Healthcare - The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software
FDA Device · Class II · 2017-07-19 · Merge Healthcare - Medica ISE Module Calibrant A
FDA Device · Class III · 2017-07-19 · Ams Diagnostics - Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear
FDA Device · Class II · 2017-07-19 · Icu Medical - Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG)…
FDA Device · Class II · 2017-07-19 · St Jude Medical - Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20
FDA Device · Class II · 2017-07-19 · Natus Neurology - Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Gluco…
FDA Device · Class II · 2017-07-19 · Beckman Coulter - The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy an…
FDA Device · Class II · 2017-07-19 · Natus Medical - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA Device · Class II · 2017-07-19 · Ge Healthcare - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general s…
FDA Device · Class II · 2017-07-19 · Icu - Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG)…
FDA Device · Class II · 2017-07-19 · St Jude Medical - Exactech Optetrak Logic CC 15mm Tibial Augment Screws
FDA Device · Class II · 2017-07-19 · Exactech
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)