FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component conta…
FDA Device · Class II · 2019-11-06 · Hycor Biomedical - ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
FDA Device · Class I · 2019-11-06 · Ethicon Endo Surgery - Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Produc…
FDA Device · Class II · 2019-11-06 · Stryker Neurovascular - Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monito…
FDA Device · Class II · 2019-11-06 · Mindray Ds Usa - ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
FDA Device · Class I · 2019-11-06 · Ethicon Endo Surgery - A&E Medical Thorecon Plating System Kits Model No. 94-1700-10
FDA Device · Class II · 2019-11-06 · Alto Development - Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Produc…
FDA Device · Class II · 2019-11-06 · Stryker Neurovascular - Kit, Port Access Product Code: DYNDC1582A
FDA Device · Class II · 2019-11-06 · Centurion Medical Products - Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The mo…
FDA Device · Class II · 2019-11-06 · Mindray Ds Usa - A&E Medical Thorecon Plating System Kits Model No. 94-1200-08
FDA Device · Class II · 2019-11-06 · Alto Development - Port full Access Tray Product Code: DT19330
FDA Device · Class II · 2019-11-06 · Centurion Medical Products - ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
FDA Device · Class I · 2019-11-06 · Ethicon Endo Surgery - Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: produc…
FDA Device · Class II · 2019-11-06 · Stryker Neurovascular - The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor
FDA Device · Class II · 2019-11-06 · Draegar Medical Systems - A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum
FDA Device · Class II · 2019-11-06 · Alto Development - Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt)
FDA Device · Class II · 2019-11-06 · Orthopediatrics - Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product U…
FDA Device · Class II · 2019-11-06 · Stryker Neurovascular - CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Bl…
FDA Device · Class I · 2019-11-06 · Thoratec Switzerland - Posey Connected Twice-As-Tough Cuffs
FDA Device · Class II · 2019-11-06 · Tidi Products - Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
FDA Device · Class II · 2019-10-30 · Siemens Healthcare Diagnostics - Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005…
FDA Device · Class II · 2019-10-30 · Life Technologies Holdings Pte - BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to…
FDA Device · Class II · 2019-10-30 · Becton Dickinson And - Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Device · Class II · 2019-10-30 · Andover Healthcare - GRIPPER Needles sold individually
FDA Device · Class II · 2019-10-30 · Smiths Medical Asd - Rifton E-Pacer, SKU K660, powered lift device
FDA Device · Class II · 2019-10-30 · Community Products - Rifton TRAM Low Base, SKU K320, powered lift device
FDA Device · Class II · 2019-10-30 · Community Products - Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Device · Class II · 2019-10-30 · Andover Healthcare - Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698
FDA Device · Class II · 2019-10-30 · Beckman Coulter - Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Produ…
FDA Device · Class II · 2019-10-30 · Arrow International - Beckman Coulter Lipase, REF OSR6130 and OSR6230
FDA Device · Class II · 2019-10-30 · Beckman Coulter - Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICE…
FDA Device · Class II · 2019-10-30 · Brainlab Ag - Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Device · Class II · 2019-10-30 · Andover Healthcare - Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser
FDA Device · Class II · 2019-10-30 · Candela - IMRIS MR/X-ray head fixation device, Model HFD200
FDA Device · Class II · 2019-10-30 · Deerfield Imaging - Semi-Rigid Suction Canister, 3000cc
FDA Device · Class II · 2019-10-30 · Medline Industries - Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser
FDA Device · Class II · 2019-10-30 · Candela - Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser
FDA Device · Class II · 2019-10-30 · Candela - Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
FDA Device · Class II · 2019-10-30 · Siemens Healthcare Diagnostics - Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser
FDA Device · Class II · 2019-10-30 · Candela - Rifton TRAM Standard Base, SKU K310, powered lift device
FDA Device · Class II · 2019-10-30 · Community Products - Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components accord…
FDA Device · Class II · 2019-10-30 · Exactech - xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel)
FDA Device · Class II · 2019-10-30 · Luminex Molecular Diagnostics - Irrisept Wound Debridement and Cleansing System. 12 units per case
FDA Device · Class II · 2019-10-30 · Irrimax - Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010
FDA Device · Class II · 2019-10-30 · Icu Medical - MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
FDA Device · Class II · 2019-10-30 · Crossroads Extremity Systems - GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU,…
FDA Device · Class II · 2019-10-30 · Smiths Medical Asd - Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Device · Class II · 2019-10-30 · Andover Healthcare - EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL
FDA Device · Class II · 2019-10-30 · Baxter Healthcare - ApexPro Telemetry Server System
FDA Device · Class II · 2019-10-30 · Ge Healthcare - Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
FDA Device · Class II · 2019-10-30 · Life Technologies Holdings Pte - Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Device · Class II · 2019-10-30 · Andover Healthcare - Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
FDA Device · Class II · 2019-10-30 · Andover Healthcare - Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and…
FDA Device · Class II · 2019-10-30 · Siemens Medical Solutions Usa - The ICS CHARTR EP 200
FDA Device · Class II · 2019-10-30 · Gn Otometrics - OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip…
FDA Device · Class II · 2019-10-30 · Omnilife Science - Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
FDA Device · Class II · 2019-10-30 · Life Technologies Holdings Pte - OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Steri…
FDA Device · Class III · 2019-10-30 · Xintec - Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-…
FDA Device · Class II · 2019-10-30 · Life Technologies Holdings Pte - Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01
FDA Device · Class II · 2019-10-30 · Abbott Laboratories - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron…
FDA Device · Class II · 2019-10-23 · Icu Medical - Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X,…
FDA Device · Class II · 2019-10-23 · Medtronic Vascular Galway - Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filte…
FDA Device · Class II · 2019-10-23 · Icu Medical - Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
FDA Device · Class II · 2019-10-23 · Xodus Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Co…
FDA Device · Class II · 2019-10-23 · Icu Medical - Cerelink ICP Monitor, Model Number 826820
FDA Device · Class II · 2019-10-23 · Integra Lifesciences - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron…
FDA Device · Class II · 2019-10-23 · Icu Medical - Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
FDA Device · Class II · 2019-10-23 · Xodus Medical - Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bi…
FDA Device · Class III · 2019-10-23 · Roche Diagnostics Operations - Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemis…
FDA Device · Class II · 2019-10-23 · Vital Scientific N V - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yello…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filt…
FDA Device · Class II · 2019-10-23 · Icu Medical - Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
FDA Device · Class II · 2019-10-23 · Xodus Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron…
FDA Device · Class II · 2019-10-23 · Icu Medical - Siemens Atellica CH 930 Analyzer
FDA Device · Class II · 2019-10-23 · Siemens Healthcare Diagnostics - Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination…
FDA Device · Class III · 2019-10-23 · Roche Diagnostics Operations - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Fil…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yello…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yello…
FDA Device · Class II · 2019-10-23 · Icu Medical - V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
FDA Device · Class II · 2019-10-23 · Vital Scientific N V - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yello…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with…
FDA Device · Class II · 2019-10-23 · Icu Medical - OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant…
FDA Device · Class II · 2019-10-23 · Orthopediatrics - Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
FDA Device · Class II · 2019-10-23 · Vital Scientific N V - Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
FDA Device · Class II · 2019-10-23 · Vital Scientific N V - Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of th…
FDA Device · Class II · 2019-10-23 · Olympus - Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filt…
FDA Device · Class II · 2019-10-23 · Icu Medical - Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Fil…
FDA Device · Class II · 2019-10-23 · Icu Medical - Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X,…
FDA Device · Class II · 2019-10-23 · Medtronic Vascular Galway - Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical labo…
FDA Device · Class II · 2019-10-23 · Vital Scientific N V - EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100
FDA Device · Class III · 2019-10-16 · Baxter Healthcare - Achilles Express Bone Sonometer
FDA Device · Class II · 2019-10-16 · Ge Healthcare - CareFusion MaxPlus Clear Needleless Connector
FDA Device · Class II · 2019-10-16 · Becton Dickinson And
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