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.
- North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system
FDA Device · Class II · 2017-11-15 · North Star Imaging - WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
FDA Device · Class II · 2017-11-15 · Teleflex Medical - Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use…
FDA Device · Class II · 2017-11-15 · Encore Medical - Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart…
FDA Device · Class II · 2017-11-15 · Invivo - Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use…
FDA Device · Class II · 2017-11-15 · Encore Medical - BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x…
FDA Device · Class II · 2017-11-15 · Becton Dickinson And - TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
FDA Device · Class II · 2017-11-15 · Epimed International - COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
FDA Device · Class II · 2017-11-15 · Epimed International - FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device
FDA Device · Class II · 2017-11-15 · Sorin Group Usa - Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cem…
FDA Device · Class II · 2017-11-15 · Encore Medical - NucliSENS Lysis Buffer Extended lot for RES 76675
FDA Device · Class II · 2017-11-15 · Biomerieux - Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cem…
FDA Device · Class II · 2017-11-15 · Encore Medical - Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100…
FDA Device · Class II · 2017-11-15 · Bioseal - AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Sci…
FDA Device · Class II · 2017-11-15 · Aaren Scientific - Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic li…
FDA Device · Class II · 2017-11-15 · Northgate Technologies - VIGILANT X4 CRT-D, Model G247, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - THERMI250 Radiofrequency System
FDA Device · Class II · 2017-11-08 · Bios S R L - THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
FDA Device · Class II · 2017-11-08 · Biosense Webster - THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
FDA Device · Class II · 2017-11-08 · Biosense Webster - THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
FDA Device · Class II · 2017-11-08 · Biosense Webster - CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer
FDA Device · Class II · 2017-11-08 · Smiths Medical Asd - CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except…
FDA Device · Class II · 2017-11-08 · Smiths Medical Asd - Alcon Custom Pak
FDA Device · Class II · 2017-11-08 · Alcon Research - Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Mar…
FDA Device · Class II · 2017-11-08 · Teleflex Medical - THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
FDA Device · Class II · 2017-11-08 · Biosense Webster - THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
FDA Device · Class II · 2017-11-08 · Biosense Webster - CADD(TM) Medication Cassette Reservoir with clamp and female Luer
FDA Device · Class II · 2017-11-08 · Smiths Medical Asd - EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra…
FDA Device · Class II · 2017-11-01 · Encore Medical - Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex…
FDA Device · Class II · 2017-11-01 · Sysmex America - EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ul…
FDA Device · Class II · 2017-11-01 · Encore Medical - MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use…
FDA Device · Class II · 2017-11-01 · Microport Orthopedics - Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symb…
FDA Device · Class II · 2017-11-01 · Siemens Medical Solutions Usa - Power Processor 1K Stockyard
FDA Device · Class II · 2017-11-01 · Beckman Coulter - BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm
FDA Device · Class II · 2017-11-01 · Bard Peripheral Vascular - Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning softwa…
FDA Device · Class II · 2017-11-01 · Nucletron Bv - The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device
FDA Device · Class I · 2017-11-01 · Origen Biomedical - GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of…
FDA Device · Class II · 2017-11-01 · W L Gore And Associates - Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasoun…
FDA Device · Class II · 2017-11-01 · Edap Technomed - PM 1250 and PM 2250 ZENEX
FDA Device · Class II · 2017-10-25 · St Jude Medical - Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
FDA Device · Class II · 2017-10-25 · St Jude Medical - Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-…
FDA Device · Class II · 2017-10-25 · Philips Electronics North America - Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-section…
FDA Device · Class II · 2017-10-25 · Philips Electronics North America - PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the b…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Anthem Model Numbers: PM3210, PM3212
FDA Device · Class II · 2017-10-25 · St Jude Medical - Proclaim DRG Implantable Pulse Generator Model 3664
FDA Device · Class II · 2017-10-25 · St Jude Medical - Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
FDA Device · Class II · 2017-10-25 · St Jude Medical - Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for rad…
FDA Device · Class II · 2017-10-25 · Toshiba American Medical Systems - Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional…
FDA Device · Class II · 2017-10-25 · Philips Electronics North America - VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip
FDA Device · Class II · 2017-10-25 · Medtronic Navigation - Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sect…
FDA Device · Class II · 2017-10-25 · Philips Electronics North America - Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
FDA Device · Class II · 2017-10-25 · Hologic - Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervi…
FDA Device · Class II · 2017-10-25 · Genesys Orthopedics Systems - PM1214 NUANCE SR RF
FDA Device · Class II · 2017-10-25 · St Jude Medical - Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indi…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sect…
FDA Device · Class II · 2017-10-25 · Philips Electronics North America - Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable…
FDA Device · Class II · 2017-10-25 · St Jude Medical - PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be p…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitt…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-section…
FDA Device · Class II · 2017-10-25 · Philips Electronics North America - Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are i…
FDA Device · Class II · 2017-10-25 · Teleflex Medical - Alaris Pump Module model 8100 manufactured between November 2011 and March 2012
FDA Device · Class II · 2017-10-25 · Carefusion 303 - Xpert EV Assay, Catalog GXEV-100N-10
FDA Device · Class II · 2017-10-25 · Cepheid - PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Assurity Model Numbers: PM1240, PM2240
FDA Device · Class II · 2017-10-25 · St Jude Medical - Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q
FDA Device · Class I · 2017-10-18 · St Jude Medical - PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
FDA Device · Class II · 2017-10-18 · Handicare Usa - ARCHITECT c4000 Cuvette Segment, List number 02P75-01
FDA Device · Class II · 2017-10-18 · Abbott Laboratories - Unify, Model Numbers: CD3231-40 and CD3231-40Q
FDA Device · Class I · 2017-10-18 · St Jude Medical - Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
FDA Device · Class II · 2017-10-18 · Handicare Ab - Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component
FDA Device · Class II · 2017-10-11 · Implant Direct Sybron Manufacturing - SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R
FDA Device · Class II · 2017-10-11 · The Metrix - AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are…
FDA Device · Class II · 2017-10-11 · Radiometer America - Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500
FDA Device · Class II · 2017-10-11 · Carl Zeiss Meditec Ag - Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
FDA Device · Class II · 2017-10-11 · Permobil Ab - Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
FDA Device · Class II · 2017-10-11 · Permobil Ab - IVEA Product Part Number 16100 Model 500A
FDA Device · Class II · 2017-10-11 · Firefly Medical - Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd.,…
FDA Device · Class II · 2017-10-11 · The Binding Site Group - BOMImed Disposable Fiber Optic Medium Laryngoscope Handle
FDA Device · Class II · 2017-10-11 · Bomimed - Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular a…
FDA Device · Class II · 2017-10-04 · Sorin Group Italia Srl Crf - Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Ou…
FDA Device · Class I · 2017-10-04 · Spectranetics - Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft t…
FDA Device · Class II · 2017-10-04 · Teleflex Medical - ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile. orthopedic surgic…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsteril…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular…
FDA Device · Class II · 2017-10-04 · Sorin Group Italia Srl Crf - ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile. orthopedic surgic…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular anti…
FDA Device · Class II · 2017-10-04 · Sorin Group Italia Srl Crf - TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34
FDA Device · Class II · 2017-10-04 · Zimmer Dental - Ultradent Products, Inc
FDA Device · Class II · 2017-10-04 · Ultradent Products - Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile. orthopedic surgical inst…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instrum…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - THREAD RETRIEVAL DRILL REF 2224
FDA Device · Class II · 2017-10-04 · Zimmer Dental - ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgica…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular anti…
FDA Device · Class II · 2017-10-04 · Sorin Group Italia Srl Crf - Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrum…
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet - Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patie…
FDA Device · Class II · 2017-10-04 · C R Bard - Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI 00480718025, Nonsterile. orthopedic surgical instrument
FDA Device · Class II · 2017-10-04 · Zimmer Biomet
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)