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.
- LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
FDA Device · Class II · 2018-07-11 · Howmedica Osteonics - microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
FDA Device · Class II · 2018-07-11 · Fhc - Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
FDA Device · Class II · 2018-07-11 · Trilliant Surgical - Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
FDA Device · Class II · 2018-07-11 · Medtronic - microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
FDA Device · Class II · 2018-07-11 · Fhc - LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
FDA Device · Class II · 2018-07-11 · Howmedica Osteonics - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - da Vinci X Surgical System, Model IS4200
FDA Device · Class II · 2018-07-11 · Intuitive Surgical - microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
FDA Device · Class II · 2018-07-11 · Fhc - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Angio-Seal Evolution Vascular Closure Device, Cat
FDA Device · Class II · 2018-07-11 · Terumo Medical - ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/sh…
FDA Device · Class III · 2018-07-11 · Ecolab - GE Healthcare CARESCAPE Monitor B650
FDA Device · Class II · 2018-07-11 · Ge Healthcare Finland Oy - Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
FDA Device · Class II · 2018-07-11 · Beaver Visitec - microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
FDA Device · Class II · 2018-07-11 · Fhc - microTargeting" Drive System, Product Number MT-DS
FDA Device · Class II · 2018-07-11 · Fhc - 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
FDA Device · Class II · 2018-07-11 · B Braun Medical - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to…
FDA Device · Class II · 2018-07-11 · Arrow International - microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
FDA Device · Class II · 2018-07-11 · Fhc - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - microTargeting" Drive System, Product Number 66-ZD-MD
FDA Device · Class II · 2018-07-11 · Fhc - St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and…
FDA Device · Class II · 2018-07-11 · St Jude Medical - ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/s…
FDA Device · Class III · 2018-07-11 · Ecolab - Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
FDA Device · Class II · 2018-07-11 · Implant Direct Sybron Manufacturing - microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
FDA Device · Class II · 2018-07-11 · Fhc - LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
FDA Device · Class II · 2018-07-11 · Howmedica Osteonics - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
FDA Device · Class II · 2018-07-11 · Howmedica Osteonics - microTargeting" Drive System, Product Number MT-DS-01
FDA Device · Class II · 2018-07-11 · Fhc - microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
FDA Device · Class II · 2018-07-11 · Fhc - microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8)
FDA Device · Class II · 2018-07-11 · Fhc - LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140
FDA Device · Class II · 2018-07-11 · Howmedica Osteonics - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FDA Device · Class II · 2018-07-11 · Fhc - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 22.5
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
FDA Device · Class II · 2018-07-04 · Intersurgical - HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160
FDA Device · Class II · 2018-07-04 · Cenorin - Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no
FDA Device · Class II · 2018-07-04 · Randox Laboratories - Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
FDA Device · Class II · 2018-07-04 · Philips Medical Systems Nederlands - Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Merlin PCS programmer (Model # 3650), Software (Model # 3330)
FDA Device · Class II · 2018-07-04 · St Jude Medical - Ingenuity Core128/Elite China 728324
FDA Device · Class II · 2018-07-04 · Philips Medical Systems Cleveland - Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no
FDA Device · Class II · 2018-07-04 · Randox Laboratories - Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
FDA Device · Class II · 2018-07-04 · Safe N Simple - Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195
FDA Device · Class II · 2018-07-04 · St Jude Medical - Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Ingenuity Core128 728323
FDA Device · Class II · 2018-07-04 · Philips Medical Systems Cleveland - Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407
FDA Device · Class II · 2018-07-04 · St Jude Medical - The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
FDA Device · Class II · 2018-07-04 · Ion Beam Applications - Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, A…
FDA Device · Class II · 2018-07-04 · B Braun Medical - Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623
FDA Device · Class II · 2018-07-04 · St Jude Medical - Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
FDA Device · Class II · 2018-07-04 · Exsurco Medical - Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944
FDA Device · Class II · 2018-07-04 · St Jude Medical - Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904
FDA Device · Class II · 2018-07-04 · St Jude Medical - Single Chamber Temporary External Pacemaker, Model 53401
FDA Device · Class II · 2018-07-04 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ImagePilot, Model No. D9MA
FDA Device · Class II · 2018-07-04 · Konica Minolta Medical Imaging Usa - Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095,…
FDA Device · Class II · 2018-07-04 · St Jude Medical - ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure…
FDA Device · Class II · 2018-07-04 · Horiba Instruments - Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115
FDA Device · Class II · 2018-07-04 · St Jude Medical - Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
FDA Device · Class II · 2018-07-04 · Philips Medical Systems Nederlands - Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846
FDA Device · Class II · 2018-07-04 · St Jude Medical - Ingenuity TF PET/CT 882442
FDA Device · Class II · 2018-07-04 · Philips Medical Systems Cleveland - Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
FDA Device · Class II · 2018-07-04 · Teleflex Medical Europe - Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177
FDA Device · Class II · 2018-07-04 · St Jude Medical - RayStation Radiation Therapy Treatment Planning System
FDA Device · Class II · 2018-07-04 · Raysearch Laboratories Ab - CS-7, Model No. A4C1
FDA Device · Class II · 2018-07-04 · Konica Minolta Medical Imaging Usa - Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407
FDA Device · Class II · 2018-07-04 · St Jude Medical - Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Diagnostic Ultrasound System, Aplio I-series
FDA Device · Class II · 2018-07-04 · Toshiba American Medical Systems - VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France
FDA Device · Class II · 2018-07-04 · Biomerieux - Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no
FDA Device · Class II · 2018-07-04 · Randox Laboratories - Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981
FDA Device · Class II · 2018-07-04 · St Jude Medical - Brilliance Big Bore Radiology 728244
FDA Device · Class II · 2018-07-04 · Philips Medical Systems Cleveland - Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Philips Ingenuity Core 728321
FDA Device · Class II · 2018-07-04 · Philips Medical Systems Cleveland - Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
FDA Device · Class II · 2018-07-04 · Siemens Medical Solutions Usa - Vanguard Complete Knee System
FDA Device · Class II · 2018-07-04 · Zimmer Biomet - DRILL PT GUIDE WIRE 2MM X 60CM
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 7412…
FDA Device · Class II · 2018-06-27 · Smith And Nephew - Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15
FDA Device · Class II · 2018-06-27 · Trimed - Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is inten…
FDA Device · Class III · 2018-06-27 · Quantimetrix - 3.2MM X 560MM COCR THD TIP
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17
FDA Device · Class II · 2018-06-27 · Trimed - Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter…
FDA Device · Class II · 2018-06-27 · Vascular Solutions - RECON DRILL 6MM X 439MM
FDA Device · Class II · 2018-06-27 · Zimmer Biomet - CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical vent…
FDA Device · Class II · 2018-06-27 · Datex Ohmeda
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)