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.
- Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Atellica Sample Handler Prime (SMN 11069001)
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical sp…
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
FDA Device · Class II · 2018-10-24 · Origen Biomedical - Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Atellica IM 1300 Analyzer (SMN 11066001)
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid B…
FDA Device · Class II · 2018-10-24 · Valeris Medical - Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System
FDA Device · Class II · 2018-10-24 · Thoratec Switzerland - Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher
FDA Device · Class II · 2018-10-24 · Ge Healthcare - Atellica Sample Handler Connect (SMN 11069018)
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
FDA Device · Class II · 2018-10-24 · Baxter Healthcare - Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - AS-OBGYN Information System version 7.824.x
FDA Device · Class II · 2018-10-24 · As Software - Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - "Free and Total Protein S ELISA Kit" Cat
FDA Device · Class II · 2018-10-24 · Helena Laboratories - ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB…
FDA Device · Class II · 2018-10-24 · Siemens Healthcare Diagnostics - Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer
FDA Device · Class II · 2018-10-24 · A M Systems - Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
FDA Device · Class II · 2018-10-24 · Terumo Cardiovascular Systems - Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only
FDA Device · Class II · 2018-10-24 · Cypress Medical Products - Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as…
FDA Device · Class II · 2018-10-24 · Origen Biomedical - Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
FDA Device · Class II · 2018-10-24 · Life Technologies - Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S…
FDA Device · Class II · 2018-10-24 · Ge Medical Systems - Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Fl…
FDA Device · Class II · 2018-10-24 · Siemens Medical Solutions Usa - Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
FDA Device · Class II · 2018-10-24 · Life Technologies - Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
FDA Device · Class II · 2018-10-24 · Mindray Ds Usa - Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
FDA Device · Class II · 2018-10-24 · Zimmer Biomet - BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station
FDA Device · Class III · 2018-10-17 · Becton Dickinson And - INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
FDA Device · Class II · 2018-10-17 · Incisive Surgical - BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED
FDA Device · Class II · 2018-10-17 · Angiodynamics Navilyst Medical - OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L
FDA Device · Class II · 2018-10-17 · Orthosensor - Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limit…
FDA Device · Class II · 2018-10-17 · Widex A S - Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage…
FDA Device · Class II · 2018-10-17 · Bayer Medical Care - OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L
FDA Device · Class II · 2018-10-17 · Orthosensor - Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform
FDA Device · Class II · 2018-10-17 · Implant Direct Sybron Manufacturing - OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R
FDA Device · Class II · 2018-10-17 · Orthosensor - Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm…
FDA Device · Class II · 2018-10-17 · Sterilmed - Colpo-Pneumo Occluder, Part CPO-6
FDA Device · Class II · 2018-10-17 · Coopersurgical - GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE M…
FDA Device · Class II · 2018-10-17 · Ge Healthcare Finland Oy - VITROS 5600 Integrated System- (Refurbished)
FDA Device · Class II · 2018-10-17 · Ortho Clinical Diagnostics - OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R
FDA Device · Class II · 2018-10-17 · Orthosensor - Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archivin…
FDA Device · Class II · 2018-10-17 · Agfa Healthcare Nv - VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes…
FDA Device · Class II · 2018-10-17 · Ortho Clinical Diagnostics - OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L
FDA Device · Class II · 2018-10-17 · Orthosensor - OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R
FDA Device · Class II · 2018-10-17 · Orthosensor - AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices in…
FDA Device · Class II · 2018-10-17 · Stryker Spine - Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin…
FDA Device · Class II · 2018-10-17 · Instrumentation Laboratory - Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil po…
FDA Device · Class II · 2018-10-17 · Medline Industries - Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (…
FDA Device · Class II · 2018-10-17 · Reckitt Benckiser - GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monit…
FDA Device · Class II · 2018-10-17 · Ge Healthcare Finland Oy - NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm
FDA Device · Class II · 2018-10-17 · Neomed - CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 Connection device used by physicians to provide various anesthetic and fluid a…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TK CONT EPIDURALTUOHY, Material Number 332221 Connection device used by physicians to provide various anesthetic and fluid administrati…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18TKPS CONT EPIDURAL TRAY (LF), Material Number 332216 Connection device used by physicians to provide various anesthetic and fluid admin…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchofiberscope BF-XP40
FDA Device · Class II · 2018-10-10 · Olympus - Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondar…
FDA Device · Class II · 2018-10-10 · Covidien - CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18T CONT EPIDURAL SET, Material Number 332200 Connection device used by physicians to provide various anesthetic and fluid administration…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TO CONT EPIDURAL SET LF, Material Number 332204 Connection device used by physicians to provide various anesthetic and fluid administra…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchovideoscope BF-Q180
FDA Device · Class II · 2018-10-10 · Olympus - EPID. CATH. NG, 20GA. CLOSED TIP-LF, Material Number 333541 Connection device used by physicians to provide various anesthetic and fluid ad…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing…
FDA Device · Class II · 2018-10-10 · Covidien - CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Capnostream20 (US) M W/PRINTER, Part Number CS08659
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope BF-3C160
FDA Device · Class II · 2018-10-10 · Olympus - CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 Connection device used by physicians to provide various anesthetic and fluid ad…
FDA Device · Class II · 2018-10-10 · B Braun Medical - JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 7402312…
FDA Device · Class II · 2018-10-10 · Smith And Nephew - CE17TKFS EPIDURAL TRAY, Material Number 332098 Connection device used by physicians to provide various anesthetic and fluid administration…
FDA Device · Class II · 2018-10-10 · B Braun Medical
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)