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.
- rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - radial stem implant #4 (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer, Sterile The blood…
FDA Device · Class II · 2018-08-15 · Icu Medical - 125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessor…
FDA Device · Class II · 2018-08-15 · Icu Medical - The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrad…
FDA Device · Class II · 2018-08-15 · Datex Ohmeda - 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessor…
FDA Device · Class II · 2018-08-15 · Icu Medical - Radial Head Assy Size #4, Rad
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Steri…
FDA Device · Class II · 2018-08-15 · Icu Medical - Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rH…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - radial stem implant #2 (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Pa…
FDA Device · Class I · 2018-08-15 · Vyaire Medical - 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile The…
FDA Device · Class II · 2018-08-15 · Icu Medical - 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connec…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead R…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through w…
FDA Device · Class II · 2018-08-15 · Boston Scientific - 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubin…
FDA Device · Class II · 2018-08-15 · Icu Medical - Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Ra…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Think Surgical Cutter, Flat, ¿6.2mm x 144mm
FDA Device · Class II · 2018-08-15 · Think Surgical - Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Hea…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
FDA Device · Class II · 2018-08-15 · New Era Orthopaedics - rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Hea…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use,…
FDA Device · Class II · 2018-08-15 · Icu Medical - 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Sterile…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radi…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volum…
FDA Device · Class II · 2018-08-15 · Icu Medical - 137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing acces…
FDA Device · Class II · 2018-08-15 · Icu Medical - Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Ra…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Lat Assembly, Rad Stem Implant,Collar 6mm, Size1
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Con…
FDA Device · Class II · 2018-08-15 · Icu Medical - 143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lo…
FDA Device · Class II · 2018-08-15 · Icu Medical - Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Ra…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blo…
FDA Device · Class II · 2018-08-15 · Icu Medical - 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a…
FDA Device · Class II · 2018-08-15 · Icu Medical - #2 Bipolar stem implant (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector…
FDA Device · Class II · 2018-08-15 · Icu Medical - 121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2…
FDA Device · Class II · 2018-08-15 · Icu Medical - Radio Capitellum Small, Right
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radi…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a si…
FDA Device · Class II · 2018-08-15 · Icu Medical - Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing acces…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead R…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing a…
FDA Device · Class II · 2018-08-15 · Icu Medical - 112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLA…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radi…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead R…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - #2 Bipolar radial head Implant (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing…
FDA Device · Class II · 2018-08-15 · Icu Medical - 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAV…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile The bl…
FDA Device · Class II · 2018-08-15 · Icu Medical - Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow) 1o2¿ Manifold, Baseplate, 1 Ext…
FDA Device · Class II · 2018-08-15 · Icu Medical - 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Lu…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radia…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Hea…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - radial stem implant #2 (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-inst…
FDA Device · Class I · 2018-08-15 · Qiagen Sciences - Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level)
FDA Device · Class II · 2018-08-08 · Elitech Clinical Systems Sas - Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
FDA Device · Class II · 2018-08-08 · Ge Healthcare - Optima CT 520
FDA Device · Class II · 2018-08-08 · Ge Healthcare - Elite HV Introducer, Catalog #: a) CLI-200-26
FDA Device · Class II · 2018-08-08 · Galt Medical - 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04
FDA Device · Class II · 2018-08-08 · Galt Medical - Revolution CT 160 1.5D STD WAUK
FDA Device · Class II · 2018-08-08 · Ge Healthcare - SOMATOM Perspective 16 (Model 10891666)
FDA Device · Class II · 2018-08-08 · Siemens Medical Solutions Usa - Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
FDA Device · Class III · 2018-08-08 · Diamedix - Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10
FDA Device · Class II · 2018-08-08 · Galt Medical - MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during…
FDA Device · Class II · 2018-08-08 · Integra Lifesciences - SOMATOM Scope ( Model 10967666)
FDA Device · Class II · 2018-08-08 · Siemens Medical Solutions Usa - MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification…
FDA Device · Class II · 2018-08-08 · Beckman Coulter - SOMATOM Emotion 6 (Model 10165888)
FDA Device · Class II · 2018-08-08 · Siemens Medical Solutions Usa - SOMATOM Spirit(Model 10045692 )
FDA Device · Class II · 2018-08-08 · Siemens Medical Solutions Usa - Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
FDA Device · Class II · 2018-08-08 · Covidien - Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
FDA Device · Class II · 2018-08-08 · Ge Healthcare - BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only
FDA Device · Class III · 2018-08-08 · Becton Dickinson And Bd Biosciences - Custom Made Implant System with Minimum Invasive Grower (MIG) component
FDA Device · Class II · 2018-08-08 · Howmedica Osteonics - CT Goldseal Optima CT 600
FDA Device · Class II · 2018-08-08 · Ge Healthcare - FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
FDA Device · Class II · 2018-08-08 · Stryker Neurovascular - 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01
FDA Device · Class II · 2018-08-08 · Galt Medical - MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a pa…
FDA Device · Class II · 2018-08-08 · Integra Lifesciences - MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patie…
FDA Device · Class II · 2018-08-08 · Integra Lifesciences - Discovery MI Digital Ready
FDA Device · Class II · 2018-08-08 · Ge Healthcare - MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patie…
FDA Device · Class II · 2018-08-08 · Integra Lifesciences - Liquid Cardiac Control - Level 3, cat. no
FDA Device · Class II · 2018-08-08 · Randox Laboratories - Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and t…
FDA Device · Class II · 2018-08-08 · Encore Medical - Merge Unity software, formerly known as DR Systems Unity PACS software
FDA Device · Class II · 2018-08-08 · Merge Healthcare - TVS LPA, Catalog #: DIL-059-00
FDA Device · Class II · 2018-08-08 · Galt Medical - Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300
FDA Device · Class II · 2018-08-08 · Cayenne Medical - Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15
FDA Device · Class II · 2018-08-08 · Galt Medical - 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, St…
FDA Device · Class II · 2018-08-08 · Galt Medical - Revolution EVO 3.6, labeled as a. HVY WAUK
FDA Device · Class II · 2018-08-08 · Ge Healthcare - 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12
FDA Device · Class II · 2018-08-08 · Galt Medical - SOMATOM Scope Power (Model 10967888)
FDA Device · Class II · 2018-08-08 · Siemens Medical Solutions Usa
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)