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.
- VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - Capnostream20 (US) M TO MASIMO, Part Number CS08750
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - VITROS Sodium Slides, Catalog # 837 9034
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in…
FDA Device · Class II · 2018-10-10 · Stryker Neurovascular - smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm…
FDA Device · Class III · 2018-10-10 · Smiths Medical Asd - CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55,…
FDA Device · Class I · 2018-10-10 · Endologix - VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiothe…
FDA Device · Class II · 2018-10-10 · Varian Medical Systems - CNB200S CONTIPLEX INSULATED TUOHY NDL, Material Number 331697 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/…
FDA Device · Class I · 2018-10-10 · Endologix - Bronchovidescope BF-1T240
FDA Device · Class II · 2018-10-10 · Olympus - EC20C 20G X 100CM CATH CLOSED, Material Number 333540 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam…
FDA Device · Class II · 2018-10-10 · Varian Medical Systems - GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - EC20CST 20G CLSD SOFT TIP CATH, Material Number 333521 Connection device used by physicians to provide various anesthetic and fluid adminis…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TB CONT EPIDURAL TUOHY, Material Number 332224 Connection device used by physicians to provide various anesthetic and fluid administrat…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 Connection device used by physicians to provide various anesthetic and fluid administr…
FDA Device · Class II · 2018-10-10 · B Braun Medical - C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human e…
FDA Device · Class II · 2018-10-10 · Rayner Intraocular Lenses - Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217,…
FDA Device · Class II · 2018-10-10 · Smith And Nephew - ESPOCAN SPINAL/EPID TRAY W/ 18G TUOHY, Material Number 333193 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - EC19OF SPRINGWOUND 19G EPID CATHETER, Material Number 333514 Connection device used by physicians to provide various anesthetic and fluid a…
FDA Device · Class II · 2018-10-10 · B Braun Medical - ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-…
FDA Device · Class I · 2018-10-10 · Endologix - CE18TB CONT EPIDURAL TRAY, Material Number 332222 Connection device used by physicians to provide various anesthetic and fluid administrati…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CAPNOSTREAM 20P (US) N, Part Number CS08651-01
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection device used by physicians to provide various anesthetic and fluid ad…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18TIN CONT EPIDURAL SET LF, Material Number 332201 Connection device used by physicians to provide various anesthetic and fluid administr…
FDA Device · Class II · 2018-10-10 · B Braun Medical - JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 7402111…
FDA Device · Class II · 2018-10-10 · Smith And Nephew - Bronchovideoscope BF-P240
FDA Device · Class II · 2018-10-10 · Olympus - Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing…
FDA Device · Class II · 2018-10-10 · Covidien - CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapl…
FDA Device · Class II · 2018-10-10 · Covidien - Bronchofiberscope BF-40
FDA Device · Class II · 2018-10-10 · Olympus - CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CAPNOSTREAM 20 (US) N, Part Number CS08651
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope BF-3C40
FDA Device · Class II · 2018-10-10 · Olympus - CNBFX350C CONTIPLEX CONT NERVE BLOCK, Material Number 331672 Connection device used by physicians to provide various anesthetic and fluid a…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Capnostream20 N CYVITAL, CS08799
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope BF-160
FDA Device · Class II · 2018-10-10 · Olympus - Ultrasonic Bronchoscope BF-UC160F-OL8
FDA Device · Class II · 2018-10-10 · Olympus - BULK NONSTERILE PERIFIX CATHETER CONN., Material Number 8451699N Connection device used by physicians to provide various anesthetic and flu…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 Connection device used by physicians to provide various anesthetic and fluid administr…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a…
FDA Device · Class III · 2018-10-10 · Dannoritzer Medizintechnik And Kg - Bronchovideoscope BF-P160
FDA Device · Class II · 2018-10-10 · Olympus - Capnostream20 (INTL) M, CS08654
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - ES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device used by physicians to provide various anesthetic and fluid adminis…
FDA Device · Class II · 2018-10-10 · B Braun Medical - smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style
FDA Device · Class III · 2018-10-10 · Smiths Medical Asd - OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015
FDA Device · Class II · 2018-10-10 · Johnson And Johnson Surgical Vision - EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CONTIPLEX TUOHY ULTRA 4 IN CNB400TU, LF, Material Number 331691 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18TOD CONT EPIDURAL TRAY LF, Material Number 332236 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CONTIPLEX CONT 4 IN TUOHY ULTRA PNB TRAY, Material Number 332129 Connection device used by physicians to provide various anesthetic and flu…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Airway Mobilescope MAF-TM
FDA Device · Class II · 2018-10-10 · Olympus - CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection device used by physicians to provide various anesthetic and fluid ad…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope BF-240
FDA Device · Class II · 2018-10-10 · Olympus - CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CNB200T CONTIPLEX TUOHY SET 2 IN, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid admin…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used by physicians to provide various anesthetic and fluid administra…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CAPNOSTREAM 20 (INTL) N, Part Number CS08652
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CNB400TKU NON-STIM CATH FULL KIT, Material Number 332128 Connection device used by physicians to provide various anesthetic and fluid admin…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18HK ACCU-BLOC PERIFIX KIT, Material Number 332230 Connection device used by physicians to provide various anesthetic and fluid administr…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Rhino Laryngo scope ENF-VT2
FDA Device · Class II · 2018-10-10 · Olympus - ABL90 FLEX analyzers with software versions 3.3MR1 or below
FDA Device · Class II · 2018-10-10 · Radiometer America - CE18H CONT EPIDURAL SET, Material Number 332210 Connection device used by physicians to provide various anesthetic and fluid administration…
FDA Device · Class II · 2018-10-10 · B Braun Medical - EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection device used by physicians to provide various anesthetic and fluid adm…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia s…
FDA Device · Class II · 2018-10-10 · Surge Medical Sales Dba Surge Cardiovascular - Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory…
FDA Device · Class II · 2018-10-10 · Leica Microsystems - Capnostream20 (INTL) M REFURBISHED, CS78654
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - EC20CS EPIDURAL CATHETER, Material Number 333532 Connection device used by physicians to provide various anesthetic and fluid administratio…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope BF-P180
FDA Device · Class II · 2018-10-10 · Olympus - GOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 Connection device used by physicians to provide various anesthetic and fluid admini…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connection device used by physicians to provide various anesthetic and flu…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchofiberscope BF-XP60
FDA Device · Class II · 2018-10-10 · Olympus - CONTI ECHO CT W/2IN TUOHY ULTRA 360 SET, Material Number 331767 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - DESIGN OPTIONS¿ PAIN MANAGEMENT TRAY, Material Numbers 530029, 530029, 530031, 530035, 530041, 530048, 530068, 530071, 530083, 530108, 5301…
FDA Device · Class II · 2018-10-10 · B Braun Medical - ES1725K SPINAL/EPIDURAL TRAY, Material Number 333165 Connection device used by physicians to provide various anesthetic and fluid administr…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - EC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 Connection device used by physicians to provide various anesthetic and fluid admi…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18HKCD CONT EPIDURAL TRAY, Material Number 332206 Connection device used by physicians to provide various anesthetic and fluid administra…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CONTIPLEX TUOHY SET, 18GX6", 1.3X150MM, Material Number 331694 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchofiberscope BF-P40
FDA Device · Class II · 2018-10-10 · Olympus - CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is…
FDA Device · Class II · 2018-10-10 · Heartware - CE18HKST CONT EPID 20G SOFTIP, Material Number 332084 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection device used by physicians to provide various anesthetic and fluid adm…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Capnostream20 (US)M REFURBISHED, Part Number CS78653
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987
Other years
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