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.
- Connecting Bolt, Model 14-442093
FDA Device · Class II · 2018-08-29 · Zimmer Biomet - DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
FDA Device · Class II · 2018-08-29 · O Two Medical Technologies - DigitalDiagnost Release 3 (Stitching Patient Support) 712025
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for…
FDA Device · Class II · 2018-08-29 · Biomerieux - Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare pr…
FDA Device · Class II · 2018-08-29 · Philips Electronics North America - The Tri-Flo Subglottic Suction System
FDA Device · Class I · 2018-08-29 · Vyaire Medical - Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tom…
FDA Device · Class II · 2018-08-29 · Hitachi Medical Systems America - CombiDiagnost R90 (Stitching Patient Support) 709030
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the ph…
FDA Device · Class III · 2018-08-29 · Euro Diagnostica Ab - DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedur…
FDA Device · Class II · 2018-08-29 · Liebel Flarsheim - DigitalDiagnost 4.1 (Stitching Patient Support) 712225
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the ph…
FDA Device · Class III · 2018-08-29 · Euro Diagnostica Ab - is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of anti…
FDA Device · Class III · 2018-08-29 · Euro Diagnostica Ab - DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - CPAP Mask Cushion, Model Nos
FDA Device · Class I · 2018-08-29 · Compass Health Brands Corporate Office - DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgica…
FDA Device · Class II · 2018-08-29 · Richard Wolf - Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another
FDA Device · Class II · 2018-08-29 · Handicare Usa - Vertebral Motion Analyzer (VMA), 2.3.250
FDA Device · Class II · 2018-08-29 · Ortho Kinematics - Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PR…
FDA Device · Class II · 2018-08-29 · Stryker - DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680
FDA Device · Class II · 2018-08-29 · Ge Healthcare Japan - Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another
FDA Device · Class II · 2018-08-29 · Handicare Usa - EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibo…
FDA Device · Class II · 2018-08-29 · Euro Diagnostica Ab - DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infin…
FDA Device · Class II · 2018-08-29 · Elekta - CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is in…
FDA Device · Class II · 2018-08-29 · In2bones Usa - bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefot…
FDA Device · Class I · 2018-08-29 · Biomerieux - 3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is movea…
FDA Device · Class II · 2018-08-29 · Siemens Medical Solutions Usa - 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or th…
FDA Device · Class II · 2018-08-29 · Siemens Medical Solutions Usa - Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws…
FDA Device · Class II · 2018-08-29 · Trimed - GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
FDA Device · Class II · 2018-08-29 · Smith And Nephew - DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - DigitalDiagnost Release 3 (Stitching Patient Support) 712025
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - GE Healthcare Optima CT540
FDA Device · Class II · 2018-08-29 · Ge Healthcare Japan - DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical pr…
FDA Device · Class II · 2018-08-29 · Zimmer Biomet - Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and…
FDA Device · Class II · 2018-08-29 · Philips Electronics North America - GE Healthcare Optima CT660
FDA Device · Class II · 2018-08-29 · Ge Healthcare Japan - Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide im…
FDA Device · Class II · 2018-08-29 · Back 2 Basics Direct - Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The Sure…
FDA Device · Class II · 2018-08-29 · Philips Electronics North America - DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power
FDA Device · Class II · 2018-08-29 · Johnson And Johnson Vision Care - CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is ind…
FDA Device · Class II · 2018-08-29 · In2bones Usa - GE Healthcare Optima CT660
FDA Device · Class II · 2018-08-29 · Ge Healthcare Japan - Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whene…
FDA Device · Class II · 2018-08-29 · Philips Electronics North America - DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254
FDA Device · Class II · 2018-08-29 · Ortho Kinematics - MOSAIQ Oncology Information System
FDA Device · Class II · 2018-08-29 · Elekta - DigitalDiagnost Single Detector (Stitching Patient Support) 712020
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat
FDA Device · Class II · 2018-08-29 · Arrow International - DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures…
FDA Device · Class II · 2018-08-29 · Liebel Flarsheim - DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound trans…
FDA Device · Class II · 2018-08-29 · Civco Medical Instruments - DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian
FDA Device · Class II · 2018-08-29 · Carestream Medical - 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clam…
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - Artis Q. angiography system
FDA Device · Class II · 2018-08-22 · Siemens Medical Solutions Usa - MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of p…
FDA Device · Class II · 2018-08-22 · Mevion Medical Systems - Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Inter…
FDA Device · Class II · 2018-08-22 · Mako Surgical - Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
FDA Device · Class II · 2018-08-22 · Sorin Crm Sas - 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valv…
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the…
FDA Device · Class III · 2018-08-22 · Richard Allan Scientific - ARTIS Pheno Model 10849000
FDA Device · Class II · 2018-08-22 · Siemens Medical Solutions Usa - 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adult…
FDA Device · Class II · 2018-08-22 · Hamilton Medical Ag - NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessor…
FDA Device · Class II · 2018-08-22 · Nxstage Medical - PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring…
FDA Device · Class II · 2018-08-22 · Terumo Cardiovascular Systems - Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
FDA Device · Class II · 2018-08-22 · Sorin Crm Sas - Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, steril…
FDA Device · Class II · 2018-08-22 · Guangzhou Improve Medical Instruments - Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or…
FDA Device · Class II · 2018-08-22 · Cypress Medical Products - TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid…
FDA Device · Class II · 2018-08-22 · Guangzhou Wondfo Biotech - Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults…
FDA Device · Class II · 2018-08-22 · Hamilton Medical Ag - S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography
FDA Device · Class II · 2018-08-22 · Beekley - 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
FDA Device · Class II · 2018-08-22 · Withings Sas - VentriClear Ventricular Drainage Catheter Set, Cat
FDA Device · Class II · 2018-08-22 · Cook - Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are fill…
FDA Device · Class II · 2018-08-22 · Apollo Endosurgery - NICO Shepherd' s Hook - Greenberg, sterile
FDA Device · Class II · 2018-08-22 · Nico - 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red…
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿…
FDA Device · Class II · 2018-08-22 · Guangzhou Wondfo Biotech - DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold,…
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic…
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (P…
FDA Device · Class II · 2018-08-22 · Merit Medical Systems - 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem
FDA Device · Class II · 2018-08-22 · Zimmer Biomet - 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer
FDA Device · Class II · 2018-08-22 · Icu Medical De Mexico - Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent…
FDA Device · Class III · 2018-08-22 · Tosoh Bioscience
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