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.
- CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by physicians to provide various anesthetic and fluid admi…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Ultrasonic Bronchoscope BF-UC180F
FDA Device · Class II · 2018-10-10 · Olympus - Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - NES1727KFX W /17GA TUOHY 19GA SPRW OT, Material Number 333197 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - GOVCE18TKST CONT EPID W/SOFT TIP, Material Number 332604 Connection device used by physicians to provide various anesthetic and fluid admin…
FDA Device · Class II · 2018-10-10 · B Braun Medical - ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single us…
FDA Device · Class II · 2018-10-10 · Icu Medical - Capnostream20 (US) M, Part Number CS08653
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope BF-MP60
FDA Device · Class II · 2018-10-10 · Olympus - smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213…
FDA Device · Class III · 2018-10-10 · Smiths Medical Asd - CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Capnostream20 N W/PRINTER CYVITAL, CS08798
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Capnostream20 (US) N REFURBISHED, Part Number CS78651
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope BF-XP160F
FDA Device · Class II · 2018-10-10 · Olympus - CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchofiberscope BF-XT40
FDA Device · Class II · 2018-10-10 · Olympus - EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchovideoscope BF-Q180-AC
FDA Device · Class II · 2018-10-10 · Olympus - CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - ES1725KFX ESPOCAN SPINAL/EPID. TRAY, Material Number 333196 Connection device used by physicians to provide various anesthetic and fluid ad…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchovideoscope BF-1T40
FDA Device · Class II · 2018-10-10 · Olympus - CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the tempera…
FDA Device · Class II · 2018-10-10 · Cincinnati Sub Zero Products A Gentherm - CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Capnostream20 (INTL) N REFURBISHED, CS78652
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope BF-XT160
FDA Device · Class II · 2018-10-10 · Olympus - CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CLAMP STYLE CATHETER CONNECTOR 20GA- LF, Material Number 332283 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style
FDA Device · Class III · 2018-10-10 · Smiths Medical Asd - Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for me…
FDA Device · Class II · 2018-10-10 · Leica Microsystems - Bronchofiberscope BF-P60
FDA Device · Class II · 2018-10-10 · Olympus - CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connection device used by physicians to provide various anesthetic and flu…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection device used by physicians to provide various anesthetic and fluid a…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchovideoscope BF-1T180
FDA Device · Class II · 2018-10-10 · Olympus - ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22…
FDA Device · Class I · 2018-10-10 · Endologix - Capnostream20 M NICU (CPM), CS08654RN
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - CE17T CONT EPIDURAL SET, Material Number 332202 Connection device used by physicians to provide various anesthetic and fluid administration…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device used by physicians to provide various anesthetic and fluid administr…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection device used by physicians to provide various anesthetic and flui…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchofibercope BF-6C240
FDA Device · Class II · 2018-10-10 · Olympus - Bronchofiberscope F-1T160
FDA Device · Class II · 2018-10-10 · Olympus - CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connection device used by physicians to provide various anesthetic and flu…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only
FDA Device · Class II · 2018-10-10 · Vision Rt - CE17TKST CONT EPID W/SOFT TIP, Material Number 332082 Connection device used by physicians to provide various anesthetic and fluid administ…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 Connection device used by physicians to provide various anesthetic and fluid admini…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CE18TKDP CONT EPID/DURAPREP, Material Number 332215 Connection device used by physicians to provide various anesthetic and fluid administra…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CE18HKPS CONTIN. EPIDURAL TRAY, Material Number 332231 Connection device used by physicians to provide various anesthetic and fluid adminis…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
FDA Device · Class II · 2018-10-10 · Exactech - CE18TBLS CONT EPIDURAL TRAY, Material Number 332219 Connection device used by physicians to provide various anesthetic and fluid administra…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchovideoscope BF-1T60
FDA Device · Class II · 2018-10-10 · Olympus - ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience,…
FDA Device · Class II · 2018-10-10 · Ellex Iscience - CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Capnostream20 (INTL) M W/PRINTER, CS08660
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for…
FDA Device · Class II · 2018-10-10 · Covidien - Capnostream20 M ADULT ICU (CPM), CS08654RA
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style
FDA Device · Class III · 2018-10-10 · Smiths Medical Asd - CE18TKCD10L 18GA TUOHY/10CC GLAS, Material Number 332217 Connection device used by physicians to provide various anesthetic and fluid admin…
FDA Device · Class II · 2018-10-10 · B Braun Medical - CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Bronchovideoscope BF-MP160F
FDA Device · Class II · 2018-10-10 · Olympus - CE17TKF PERIFIX CONTIN. EPIDURAL TRAY, Material Number 332086 Connection device used by physicians to provide various anesthetic and fluid…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Capnostream20 M W/PRINTER CYVITAL, CS08796
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - CE17TK19CDP CONT EPIDURAL TRAY, Material Number 332262 Connection device used by physicians to provide various anesthetic and fluid adminis…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dre…
FDA Device · Class II · 2018-10-10 · Covidien - CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by physicians to provide various anesthetic and fluid admin…
FDA Device · Class II · 2018-10-10 · B Braun Medical - Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dre…
FDA Device · Class II · 2018-10-10 · Covidien - CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - Bronchovideoscope F-1TQ180
FDA Device · Class II · 2018-10-10 · Olympus - CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
FDA Device · Class II · 2018-10-10 · Oridion Medical 1987 - GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection device used by physicians to provide various anesthetic and fluid a…
FDA Device · Class II · 2018-10-10 · B Braun Medical - ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
FDA Device · Class II · 2018-10-03 · Swissray Medical - Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includi…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includi…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the per…
FDA Device · Class II · 2018-10-03 · Shockwave Medical - INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includin…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for tem…
FDA Device · Class II · 2018-10-03 · Zimmer Biomet - DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and me…
FDA Device · Class II · 2018-10-03 · Agfa N V - INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applicati…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures
FDA Device · Class II · 2018-10-03 · Terumo Cardiovascular Systems - HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC…
FDA Device · Class II · 2018-10-03 · Biomet Uk
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)