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.
- HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Ma…
FDA Device · Class II · 2018-08-22 · Arrow International - 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-i…
FDA Device · Class II · 2018-08-22 · Convatec - Monitor with one Blood Parameter Module and one HSat Probe
FDA Device · Class II · 2018-08-22 · Terumo Cardiovascular Systems - 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic devi…
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body
FDA Device · Class II · 2018-08-22 · Merit Medical Systems - O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography
FDA Device · Class II · 2018-08-22 · Beekley - 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
FDA Device · Class II · 2018-08-22 · Zimmer Biomet - The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller
FDA Device · Class II · 2018-08-22 · Intuitive Surgical - 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcoc…
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Ma…
FDA Device · Class II · 2018-08-22 · Arrow International - TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography
FDA Device · Class II · 2018-08-22 · Beekley - Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualita…
FDA Device · Class III · 2018-08-22 · Clarity Diagnostics - Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999
FDA Device · Class I · 2018-08-22 · Spacelabs Healthcare - TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube¿ O…
FDA Device · Class II · 2018-08-22 · Guangzhou Wondfo Biotech - Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in sal…
FDA Device · Class II · 2018-08-22 · Drg Instruments - PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560
FDA Device · Class II · 2018-08-22 · Tosoh Bioscience - MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Device · Class II · 2018-08-22 · Megadyne Medical Products - 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic de…
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile The blo…
FDA Device · Class II · 2018-08-15 · Icu Medical - 126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The blood…
FDA Device · Class II · 2018-08-15 · Icu Medical - Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
FDA Device · Class II · 2018-08-15 · Smiths Medical Asd - #1 Bipolar stem implant (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Recon Stem Implant 6mm Collar, Size 3. 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 - Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of…
FDA Device · Class II · 2018-08-15 · Arjohuntleigh Magog - rHead Stem Implant Plasma Coated, 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 - AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004
FDA Device · Class I · 2018-08-15 · Vyaire Medical - Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rH…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubin…
FDA Device · Class II · 2018-08-15 · Icu Medical - Radio Capitellum, Recon Head, Size #3. 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 - Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust IC…
FDA Device · Class II · 2018-08-15 · Natus Neurology - Lateral Assembly, Radial Head 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 Recon Extended Stem Size 3. 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 - rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - radial head implant #3 (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a p…
FDA Device · Class II · 2018-08-15 · Arjohuntleigh Magog - #4 Bipolar radial head Implant (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - radial stem implant #1 (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - #3 Bipolar radial head Implant (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003
FDA Device · Class II · 2018-08-15 · Vitalgo - 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear,…
FDA Device · Class II · 2018-08-15 · Icu Medical - 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory with…
FDA Device · Class II · 2018-08-15 · Icu Medical - 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory…
FDA Device · Class II · 2018-08-15 · Icu Medical - Radial Head Assy Size #2, Rad
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rH…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Ster…
FDA Device · Class II · 2018-08-15 · Icu Medical - #3 Bipolar stem implant (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - radial head implant #4 (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Stem Implant 6mm Collar, 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 - Leica M530 OHX Microscope System Supplied with 100 - 120 Vac
FDA Device · Class II · 2018-08-15 · Leica Microsystems - radial head implant #2 (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing…
FDA Device · Class II · 2018-08-15 · Icu Medical - 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotati…
FDA Device · Class II · 2018-08-15 · Icu Medical - 119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile…
FDA Device · Class II · 2018-08-15 · Icu Medical - 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The bloo…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Stem Implant Plasma Coated, Size 1. 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 - radial stem implant #3 (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Recon Stem Implant Plasma Coated, Size 3. 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 - Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pier…
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 - Lateral Assembly, Radial Head Implant, Size 2. 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, Radial Implant 6 mm Collar, 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 - Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operat…
FDA Device · Class II · 2018-08-15 · Water Pik - 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood…
FDA Device · Class II · 2018-08-15 · Icu Medical - Radio Capitellum Broach Large, Right
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Radio Capitellum Large, Right
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead, Radial Implant 6 mm Collar, Size 1. 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 - #4 Bipolar stem implant (Sterile packed)
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connecto…
FDA Device · Class II · 2018-08-15 · Icu Medical - Lateral Assembly, Radial Stem Implant, Size 2. 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 - 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a s…
FDA Device · Class II · 2018-08-15 · Icu Medical - rHead Recon Stem Implant 6mm Collar, Size 2. 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 - Radio Capitellum Small, Left
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - 185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use,…
FDA Device · Class II · 2018-08-15 · Icu Medical - 132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing acces…
FDA Device · Class II · 2018-08-15 · Icu Medical - Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System
FDA Device · Class II · 2018-08-15 · Ino Therapeutics Dba Ikaria - Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial H…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery
FDA Device · Class II · 2018-08-15 · Beaver Visitec - Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an…
FDA Device · Class II · 2018-08-15 · Icu Medical - 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing acces…
FDA Device · Class II · 2018-08-15 · Icu Medical - 80" (203 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 - rHead Stem Implant 6mm Collar, Size 3. 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 - 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubin…
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 - Radial Head Assy Size #3, Rad
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - rHead Recon Stem Implant non-coated, Size 2. 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 - 175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating…
FDA Device · Class II · 2018-08-15 · Icu Medical - Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-…
FDA Device · Class II · 2018-08-15 · Howmedica Osteonics - iTOVi Tracker/Scanner, Model Nos
FDA Device · Class II · 2018-08-15 · Hudson Scientific - 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE…
FDA Device · Class II · 2018-08-15 · Icu Medical - Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion…
FDA Device · Class II · 2018-08-15 · Medtronic Sofamor Danek Usa - rHead Recon Stem Implant non-coated, Size 3. 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
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)