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.
- Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Suli…
FDA Device · Class II · 2018-02-14 · Angiodynamics - The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, gra…
FDA Device · Class II · 2018-02-14 · Microline Surgical - Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical p…
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at…
FDA Device · Class II · 2018-02-14 · Cardiovascular Systems - VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS…
FDA Device · Class II · 2018-02-14 · Cyberonics - BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging a…
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at…
FDA Device · Class II · 2018-02-14 · Cardiovascular Systems - Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and T…
FDA Device · Class II · 2018-02-14 · Zimmer Biomet - Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
FDA Device · Class II · 2018-02-14 · Covidien - Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires…
FDA Device · Class II · 2018-02-14 · Zimmer Biomet - SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802
FDA Device · Class II · 2018-02-14 · Convatec - Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Commun…
FDA Device · Class II · 2018-02-14 · Siemens Medical Solutions Usa - DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
FDA Device · Class II · 2018-02-14 · Zimmer Biomet - Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
FDA Device · Class II · 2018-02-14 · Covidien - Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V G…
FDA Device · Class II · 2018-02-14 · Angiodynamics - Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure
FDA Device · Class II · 2018-02-14 · Robert Busse And D B A Busse Hospital Disposables - Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis…
FDA Device · Class II · 2018-02-14 · Angiodynamics - Philips Brilliance 64 computed tomography x-ray system
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
FDA Device · Class II · 2018-02-14 · Philips Medical Systems Cleveland - 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product…
FDA Device · Class II · 2018-02-14 · Medical Components - M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Produ…
FDA Device · Class II · 2018-02-14 · Zimmer Biomet - Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are…
FDA Device · Class II · 2018-02-14 · Covidien - Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor i…
FDA Device · Class II · 2018-02-14 · The Binding Site Group - ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack
FDA Device · Class II · 2018-02-14 · Siemens Healthcare Diagnostics - PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
FDA Device · Class II · 2018-02-14 · Panoramic Rental - MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the terminatio…
FDA Device · Class I · 2018-02-14 · Philips North America - Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures
FDA Device · Class II · 2018-02-14 · Medtronic Perfusion Systems - Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
FDA Device · Class II · 2018-02-14 · Covidien - Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Gener…
FDA Device · Class II · 2018-02-14 · Angiodynamics - Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use…
FDA Device · Class II · 2018-02-14 · Exactech - Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
FDA Device · Class II · 2018-02-14 · Covidien - Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A
FDA Device · Class II · 2018-02-07 · Siemens Medical Solutions Usa - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bev…
FDA Device · Class II · 2018-02-07 · Beaver Visitec International - Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Speci…
FDA Device · Class II · 2018-02-07 · Beaver Visitec International - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with…
FDA Device · Class II · 2018-02-07 · Exactech - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump
FDA Device · Class II · 2018-02-07 · Smiths Medical Asd - Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart C…
FDA Device · Class II · 2018-02-07 · Edwards Lifesciences - Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04…
FDA Device · Class II · 2018-02-07 · Roche Diagnostics - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Stra…
FDA Device · Class II · 2018-02-07 · Beaver Visitec International - Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal
FDA Device · Class II · 2018-02-07 · Carl Zeiss Metrology - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut inci…
FDA Device · Class II · 2018-02-07 · Beaver Visitec International - Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty…
FDA Device · Class II · 2018-02-07 · Beaver Visitec International - 7x10" Small Utility Positioner with Cover
FDA Device · Class II · 2018-02-07 · Molnlycke Health Care - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is ind…
FDA Device · Class II · 2018-02-07 · C R Bard - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932
FDA Device · Class II · 2018-02-07 · Tosoh Bioscience - Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments - Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals wit…
FDA Device · Class II · 2018-02-07 · Exactech - 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments - Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - 9x15" Medium Utility Positioner with Cover
FDA Device · Class II · 2018-02-07 · Molnlycke Health Care - Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admi…
FDA Device · Class II · 2018-02-07 · Baxter Healthcare - Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet
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)