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.
- TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Ne…
FDA Device · Class II · 2018-03-21 · Siemens Medical Solutions Usa - PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA)
FDA Device · Class II · 2018-03-21 · Smiths Medical Asd - CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT)
FDA Device · Class II · 2018-03-21 · Diagnostica Stago - CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA i…
FDA Device · Class II · 2018-03-21 · Hyphen Biomed - Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX P…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATC…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT)
FDA Device · Class II · 2018-03-21 · Diagnostica Stago - Alden HP59 Toric Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Reuter Tip Deflecting Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in…
FDA Device · Class III · 2018-03-21 · Philips Electronics North America - Vial2BagDC, Product Number 6070112
FDA Device · Class II · 2018-03-21 · Medimop Medical Projects - Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is in…
FDA Device · Class II · 2018-03-21 · Arrow International - Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Amplatz Extra Stiff Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - T/Pump temperature therapy pump, Models TP700 and TP700C
FDA Device · Class III · 2018-03-21 · Stryker Medical Division - Accolade and Restoration hip product
FDA Device · Class II · 2018-03-21 · Howmedica Osteonics - Fixed Core Bentson
FDA Device · Class II · 2018-03-21 · Cook - Movable Core Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - Disposable Reuter Tip Deflecting Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - IMRIS ORT100 Table, Part Number 110470-000
FDA Device · Class II · 2018-03-21 · Deerfield Imaging - LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORA…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Fixed Core Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570)
FDA Device · Class II · 2018-03-21 · Baxter Healthcare - LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Amplatz Extra Stiff Whisker Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - Bentson Cerebral Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - Bentson Plus Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus O…
FDA Device · Class II · 2018-03-21 · Ion Beam Applications - Rosen Curved Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays
FDA Device · Class II · 2018-03-21 · Medtronic Minimally Invasive Therapies Group - Alden Classic 38 Sphere Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - Alden HP54 Toric Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-00…
FDA Device · Class II · 2018-03-21 · Stanbio Laboratory - IMRIS T2X Table, Part Number 109682-600
FDA Device · Class II · 2018-03-21 · Deerfield Imaging - Alden HP49 Sphere Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constrained, Me…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
FDA Device · Class III · 2018-03-21 · Randox Laboratories - Amplatz Ultra Stiff Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM…
FDA Device · Class II · 2018-03-21 · Hyphen Biomed - Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medi…
FDA Device · Class II · 2018-03-21 · Ion Beam Applications - CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
FDA Device · Class II · 2018-03-21 · 3m Health Care Business - CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Alden HP54 Sphere Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R L…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - INFINITY DUAL HEMO MCable Pod
FDA Device · Class II · 2018-03-21 · Draegar Medical Systems - ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of disease…
FDA Device · Class II · 2018-03-21 · Arrow International - Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT)
FDA Device · Class II · 2018-03-21 · Diagnostica Stago - VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous…
FDA Device · Class II · 2018-03-21 · Arrow International - Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿…
FDA Device · Class II · 2018-03-21 · Arrow International - Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safet…
FDA Device · Class II · 2018-03-21 · Arrow International - NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - fastener, fixation, nondegradable, soft tissue
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices…
FDA Device · Class II · 2018-03-21 · Medtronic Minimally Invasive Therapies Group - AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous ac…
FDA Device · Class II · 2018-03-21 · Arrow International - VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncem…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Pr…
FDA Device · Class II · 2018-03-21 · Depuy Orthopaedics - LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - NovaKone Toric Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Bentson Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction…
FDA Device · Class II · 2018-03-21 · Fresenius Medical Care Renal Therapies Group - ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/LLAT¿ NGU PRC FEM SZD LMED/RLAT¿ ZUK PRC FEM SZD RMED/LLAT¿ ZUK…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Vygon IV Start Convenience Kits
FDA Device · Class II · 2018-03-21 · Vygon Mfg Dba Churchill Medical Systems - DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX P…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocal…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Coons Interventional Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - Amplatz Stiff Wire Guide
FDA Device · Class II · 2018-03-21 · Cook - ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joi…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous a…
FDA Device · Class II · 2018-03-21 · Arrow International - Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities
FDA Device · Class II · 2018-03-21 · Becton Dickinson And - AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous a…
FDA Device · Class II · 2018-03-21 · Arrow International - ASTERA Multifocal Toric Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Med…
FDA Device · Class II · 2018-03-21 · Stryker - JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - TFE Coated Curved Newton LLT
FDA Device · Class II · 2018-03-21 · Cook - STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT)
FDA Device · Class II · 2018-03-21 · Diagnostica Stago - GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transpor…
FDA Device · Class II · 2018-03-21 · Laerdal Medical - Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA)
FDA Device · Class II · 2018-03-21 · Smiths Medical Asd - CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ D-R¿ CR-FLEX GSF PRECOAT SZ E-L¿…
FDA Device · Class II · 2018-03-21 · Zimmer Biomet - Femoral Artery Pressure Monitoring Set
FDA Device · Class II · 2018-03-21 · Cook - Alden Classic 55 Toric Daily Wear Soft contact
FDA Device · Class II · 2018-03-21 · Alden Optical - ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) cent…
FDA Device · Class II · 2018-03-21 · Arrow International
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)