FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - VITEK¿ 2 Gram Positive Susceptibility card (AST-GP71), REF 410750, 20 cards per carton
FDA Device · Class II · 2017-06-21 · Biomerieux - VITEK¿ 2 Gram Negative Susceptibility card (AST-N345), IVD, REF 420580, 20 cards per carton
FDA Device · Class II · 2017-06-21 · Biomerieux - Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - VITEK¿ 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton
FDA Device · Class II · 2017-06-21 · Biomerieux - FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RI…
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and…
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - Por fullct fem st 17x200mm, Sterile
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and…
FDA Device · Class II · 2017-06-21 · Zimmer Biomet - VITEK¿ 2 Gram Negative Susceptibility card (AST-N203), REF 412864, 20 cards per carton
FDA Device · Class II · 2017-06-21 · Biomerieux - VITEK¿ 2 Gram Negative Susceptibility card (AST-N324), IVD, REF 418603, 20 cards per carton
FDA Device · Class II · 2017-06-21 · Biomerieux - AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or…
FDA Device · Class II · 2017-06-14 · Arrow International - Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" P…
FDA Device · Class II · 2017-06-14 · Arrow International - Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Feat…
FDA Device · Class II · 2017-06-14 · Arrow International - Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Pr…
FDA Device · Class II · 2017-06-14 · Arrow International - ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Ac…
FDA Device · Class II · 2017-06-14 · Arrow International - LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Device · Class II · 2017-06-14 · Cook - ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit
FDA Device · Class II · 2017-06-14 · Arrow International - Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" P…
FDA Device · Class II · 2017-06-14 · Arrow International - Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001,…
FDA Device · Class II · 2017-06-14 · Zimmer Biomet Spine - Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety…
FDA Device · Class II · 2017-06-14 · Arrow International - Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral acce…
FDA Device · Class II · 2017-06-14 · Arrow International - ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for…
FDA Device · Class II · 2017-06-14 · Arrow International - Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E,…
FDA Device · Class II · 2017-06-14 · Convatec - Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral acce…
FDA Device · Class II · 2017-06-14 · Arrow International - Magellan Diagnostics LeadCare and LeadCare II test Kits
FDA Device · Class I · 2017-06-14 · Magellan Diagnostics - Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
FDA Device · Class II · 2017-06-14 · Arrow International - Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-…
FDA Device · Class II · 2017-06-14 · Alphatec Spine - LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Device · Class II · 2017-06-14 · Cook - Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
FDA Device · Class II · 2017-06-14 · Convatec - Beekley Medical 0-SPOT Mammography Skin Markers REF 652
FDA Device · Class III · 2017-06-14 · Beekley - Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console…
FDA Device · Class II · 2017-06-14 · Arrow International - Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
FDA Device · Class II · 2017-06-14 · Iba Dosimetry - Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector C…
FDA Device · Class II · 2017-06-14 · Convatec - Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral a…
FDA Device · Class II · 2017-06-14 · Arrow International - ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide shor…
FDA Device · Class II · 2017-06-14 · Arrow International - Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Device · Class II · 2017-06-14 · Cook - Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console…
FDA Device · Class II · 2017-06-14 · Arrow International - Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Ch…
FDA Device · Class II · 2017-06-14 · Convatec - Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p…
FDA Device · Class II · 2017-06-14 · Roche Diagnostics - Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease producti…
FDA Device · Class III · 2017-06-14 · Acumedia Manufacturers - Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use o…
FDA Device · Class II · 2017-06-14 · Arrow International - Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Device · Class II · 2017-06-14 · Cook - Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg+ard Blue Plus" antimicrobial catheter i…
FDA Device · Class II · 2017-06-14 · Arrow International - Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is…
FDA Device · Class II · 2017-06-14 · Arrow International - Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral a…
FDA Device · Class II · 2017-06-14 · Arrow International - Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimic…
FDA Device · Class II · 2017-06-14 · Arrow International - Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard Blue…
FDA Device · Class II · 2017-06-14 · Arrow International - NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. Th…
FDA Device · Class II · 2017-06-14 · Nexstim - ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for…
FDA Device · Class II · 2017-06-14 · Arrow International - MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and M…
FDA Device · Class II · 2017-06-14 · Arrow International - Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 91…
FDA Device · Class II · 2017-06-14 · Convatec - Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Shea…
FDA Device · Class II · 2017-06-14 · Arrow International - Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
FDA Device · Class II · 2017-06-14 · Convatec - ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit
FDA Device · Class II · 2017-06-14 · Arrow International - Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation…
FDA Device · Class II · 2017-06-14 · Arrow International - Arterial Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other s…
FDA Device · Class II · 2017-06-14 · Arrow International - ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide shor…
FDA Device · Class II · 2017-06-14 · Arrow International - Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based…
FDA Device · Class II · 2017-06-14 · Orthosoft - Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" P…
FDA Device · Class II · 2017-06-14 · Arrow International - Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal…
FDA Device · Class II · 2017-06-14 · Arrow International - Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use o…
FDA Device · Class II · 2017-06-14 · Arrow International - Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation…
FDA Device · Class II · 2017-06-14 · Arrow International - Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
FDA Device · Class II · 2017-06-14 · Convatec - Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
FDA Device · Class II · 2017-06-14 · Convatec - Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (…
FDA Device · Class II · 2017-06-14 · Laserex Systems - Pediatric, High Conc
FDA Device · Class II · 2017-06-14 · Convatec - Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introdu…
FDA Device · Class II · 2017-06-14 · Arrow International - "Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits veno…
FDA Device · Class II · 2017-06-14 · Arrow International - Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral acce…
FDA Device · Class II · 2017-06-14 · Arrow International - QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral a…
FDA Device · Class II · 2017-06-14 · Arrow International - KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R
FDA Device · Class II · 2017-06-14 · Medtronic Sofamor Danek Usa - QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arte…
FDA Device · Class II · 2017-06-14 · Arrow International - Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central c…
FDA Device · Class II · 2017-06-14 · Arrow International - Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product…
FDA Device · Class II · 2017-06-14 · Convatec - Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only
FDA Device · Class II · 2017-06-14 · Teleflex Medical - Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimic…
FDA Device · Class II · 2017-06-14 · Arrow International - ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permit…
FDA Device · Class II · 2017-06-14 · Arrow International - MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and bla…
FDA Device · Class III · 2017-06-14 · Medtest Holdings - MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Ma…
FDA Device · Class II · 2017-06-14 · Arrow International - Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier P…
FDA Device · Class II · 2017-06-14 · Arrow International - Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body s…
FDA Device · Class II · 2017-06-14 · Stryker Communications - Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral acce…
FDA Device · Class II · 2017-06-14 · Arrow International - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Fe…
FDA Device · Class II · 2017-06-14 · Arrow International - Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
FDA Device · Class II · 2017-06-14 · Convatec - Clear Flashback Needle 7cm x 18G AMC/4
FDA Device · Class II · 2017-06-14 · Argon Medical Devices - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit
FDA Device · Class II · 2017-06-14 · Baxter Healthcare - Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
FDA Device · Class II · 2017-06-14 · Arrow International - Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector,…
FDA Device · Class II · 2017-06-14 · Convatec - SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of…
FDA Device · Class II · 2017-06-14 · Circadiance - Nexstim eXima NBS System Software version 2.2 or higher
FDA Device · Class II · 2017-06-14 · Nexstim - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial ca…
FDA Device · Class II · 2017-06-14 · Arrow International - Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits
FDA Device · Class I · 2017-06-14 · Magellan Diagnostics - ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit
FDA Device · Class II · 2017-06-14 · Arrow International - Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
FDA Device · Class II · 2017-06-14 · Convatec - Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The Arrow(r) CVC is indicated to provide s…
FDA Device · Class II · 2017-06-14 · Arrow International - Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Device · Class II · 2017-06-14 · Cook
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)