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.
- T4 Zipper Toga, (L/XL)
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table m…
FDA Device · Class II · 2018-05-02 · Synthes - BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
FDA Device · Class II · 2018-05-02 · Becton Dickinson And - ADVIA Centaur CA 125II Assay
FDA Device · Class II · 2018-05-02 · Siemens Healthcare Diagnostics - TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
FDA Device · Class II · 2018-05-02 · Integra Lifesciences - GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730,…
FDA Device · Class II · 2018-04-25 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multi…
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cr…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults
FDA Device · Class II · 2018-04-25 · Halyard Health - Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and…
FDA Device · Class II · 2018-04-25 · Stryker Medical Division - Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25…
FDA Device · Class II · 2018-04-25 · Draegar Medical Systems - T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiatio…
FDA Device · Class II · 2018-04-25 · Siemens Medical Solutions Usa - JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]
FDA Device · Class II · 2018-04-25 · Carefusion 2200 - Thoracentesis/ Paracentesis Kit 10/CS
FDA Device · Class II · 2018-04-25 · Carefusion 2200 - Intera 1.0T
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended t…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
FDA Device · Class II · 2018-04-25 · Wright Medical Technology - Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia…
FDA Device · Class II · 2018-04-25 · Teleflex Medical Europe - Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to prod…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving comple…
FDA Device · Class II · 2018-04-25 · Zimmer Biomet - Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
FDA Device · Class II · 2018-04-25 · Autochair - SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext
FDA Device · Class II · 2018-04-25 · Southern Implants - Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US
FDA Device · Class II · 2018-04-25 · Preservation Solutions - MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intende…
FDA Device · Class II · 2018-04-25 · Cook - Manometer, 550 ml three-Way Stopcock
FDA Device · Class II · 2018-04-25 · Carefusion 2200 - Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cr…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway
FDA Device · Class II · 2018-04-25 · Halyard Health - Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.…
FDA Device · Class II · 2018-04-25 · Tornier - Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607
FDA Device · Class II · 2018-04-25 · Cook - Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System
FDA Device · Class II · 2018-04-25 · Tmj Solutions - Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intend…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emi…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter…
FDA Device · Class II · 2018-04-25 · Datascope - Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pu…
FDA Device · Class II · 2018-04-25 · Datascope - ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray rad…
FDA Device · Class II · 2018-04-25 · Siemens Medical Solutions Usa - JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]
FDA Device · Class II · 2018-04-25 · Carefusion 2200 - Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature
FDA Device · Class II · 2018-04-25 · Terumo Cardiovascular Systems - Stage-1 Tissue Punch, Disposable, 4.5mm
FDA Device · Class II · 2018-04-25 · Keystone Dental - Intera 1.5T
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter…
FDA Device · Class II · 2018-04-25 · Datascope - T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver…
FDA Device · Class II · 2018-04-25 · Siemens Medical Solutions Usa - Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply te…
FDA Device · Class II · 2018-04-25 · Terumo Cardiovascular Systems - ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiati…
FDA Device · Class II · 2018-04-25 · Siemens Medical Solutions Usa - Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - T5 Model 78104 Product Usage: Indicated for use as a diagnostic device
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cro…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/u…
FDA Device · Class II · 2018-04-25 · Getinge Disinfection Ab - Human Fetal Hemoglobin (HBF-1) FITC Conjugate
FDA Device · Class II · 2018-04-25 · Life Technologies - Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems inten…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]
FDA Device · Class II · 2018-04-25 · Carefusion 2200 - Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 0734015370025…
FDA Device · Class II · 2018-04-25 · Getinge Disinfection Ab - Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cro…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 Provid…
FDA Device · Class II · 2018-04-25 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density…
FDA Device · Class II · 2018-04-25 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275
FDA Device · Class II · 2018-04-25 · Cook - ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiati…
FDA Device · Class II · 2018-04-25 · Siemens Medical Solutions Usa - Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems
FDA Device · Class II · 2018-04-25 · Angiodynamics Navilyst Medical - Sarns TCM II, Catalog Numbers: 4415
FDA Device · Class II · 2018-04-25 · Terumo Cardiovascular Systems - JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]
FDA Device · Class II · 2018-04-25 · Carefusion 2200 - Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cr…
FDA Device · Class II · 2018-04-25 · Philips Medical Systems Cleveland - PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for t…
FDA Device · Class II · 2018-04-25 · Siemens Medical Solutions Usa - Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5…
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator inte…
FDA Device · Class II · 2018-04-25 · Cook - WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
FDA Device · Class II · 2018-04-25 · Wright Medical Technology - Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
FDA Device · Class II · 2018-04-25 · Neurologica - Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
FDA Device · Class III · 2018-04-25 · Orasure Technologies - Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liq…
FDA Device · Class II · 2018-04-25 · Halyard Health - ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Multiva systems
FDA Device · Class II · 2018-04-25 · Philips Electronics North America - Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hosp…
FDA Device · Class II · 2018-04-18 · Hamilton Medical Ag - D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LO…
FDA Device · Class II · 2018-04-18 · Smith And Nephew - (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions fo…
FDA Device · Class II · 2018-04-18 · Arrow International - 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Ster…
FDA Device · Class II · 2018-04-18 · Icu Medical - iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 80…
FDA Device · Class II · 2018-04-18 · Beckman Coulter - PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
FDA Device · Class II · 2018-04-18 · Ethicon - AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A
FDA Device · Class II · 2018-04-18 · Arrow International - 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262
FDA Device · Class II · 2018-04-18 · Icu Medical - Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended t…
FDA Device · Class II · 2018-04-18 · C R Bard - AUTO REF/KERATOMETER ARK-1s
FDA Device · Class II · 2018-04-18 · Nidek - Strauss Penis Clamp 130MM/General Instruments
FDA Device · Class III · 2018-04-18 · Aesculap Implant Systems - 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item…
FDA Device · Class II · 2018-04-18 · Icu Medical - 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches…
FDA Device · Class II · 2018-04-18 · Icu Medical - Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
FDA Device · Class II · 2018-04-18 · Arrow International - ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A
FDA Device · Class II · 2018-04-18 · Arrow International - Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main…
FDA Device · Class II · 2018-04-18 · The Magstim - Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is i…
FDA Device · Class II · 2018-04-18 · Neuropro Spinal Jaxx - ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A
FDA Device · Class II · 2018-04-18 · Arrow International - Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2
FDA Device · Class II · 2018-04-18 · Arrow International - Hex Driver Part Number HXDRIVER-2.0 AO
FDA Device · Class II · 2018-04-18 · Trimed - BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320,…
FDA Device · Class II · 2018-04-18 · Beckman Coulter - Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments
FDA Device · Class II · 2018-04-18 · W And H Dentalwerk Burmoos Site 1
Other years
2026 (2,088) · 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)