FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascular…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixatio…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae…
FDA Device · Class II · 2016-07-20 · Sorin Group Usa - LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely…
FDA Device · Class II · 2016-07-20 · Hospira - Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endova…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascular…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer
FDA Device · Class II · 2016-07-20 · Novarad - Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascu…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Merge OfficePACS software
FDA Device · Class II · 2016-07-20 · Merge Healthcare - Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endova…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instr…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endo…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascu…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endova…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum,…
FDA Device · Class II · 2016-07-20 · Hospira - Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - 5.0mm Round Fluted Bur, Super Long
FDA Device · Class II · 2016-07-20 · Stryker Instruments Div - Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416…
FDA Device · Class II · 2016-07-20 · Medtronic Cardiac Rhythm And Heart Failure - 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for frac…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Us…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target Detachable Coils are intended to endovascular…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 490430…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia
FDA Device · Class II · 2016-07-20 · Hospira - Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE
FDA Device · Class II · 2016-07-20 · Varian Medical Systems - Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Merge OfficePACS software
FDA Device · Class II · 2016-07-20 · Merge Healthcare - Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovas…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - 4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80
FDA Device · Class II · 2016-07-20 · Hardy Diagnostics - Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurology: Target Detachable Coils are intended to endo…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synth…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurology: Target Detachable Coils are intended to endo…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or ep…
FDA Device · Class II · 2016-07-20 · Hospira - Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target Detachable Coils are intended to endovascular…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fract…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD
FDA Device · Class III · 2016-07-20 · Ortho Clinical Diagnostics - 6.0mm Round Fluted Bur, Super Long
FDA Device · Class II · 2016-07-20 · Stryker Instruments Div - Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixatio…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovas…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascu…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
FDA Device · Class III · 2016-07-20 · Gsk Consumer Healthcare - Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE
FDA Device · Class II · 2016-07-20 · Varian Medical Systems - Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04…
FDA Device · Class II · 2016-07-20 · Arrow International - Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815
FDA Device · Class II · 2016-07-20 · Devicor Medical Products - Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage:…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endo…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - cobas¿ Liat Influenza A/B Quality Control Kit
FDA Device · Class III · 2016-07-20 · Roche Molecular Systems - Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endova…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above
FDA Device · Class III · 2016-07-20 · Ortho Clinical Diagnostics - HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only
FDA Device · Class I · 2016-07-20 · Heartware - Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascu…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: Target Detachable Coils are intended to endovasc…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular - Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04…
FDA Device · Class II · 2016-07-20 · Arrow International - The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes th…
FDA Device · Class II · 2016-07-13 · Custom Ultrasonics - Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only
FDA Device · Class II · 2016-07-13 · Medtronic Cardiac Rhythm And Heart Failure - Covidien Cytosponge Cell Collection Device
FDA Device · Class II · 2016-07-13 · Covidien - Medtronic 0-arm Imaging mobile x-ray system
FDA Device · Class II · 2016-07-13 · Medtronic Navigation Littleton - ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30…
FDA Device · Class II · 2016-07-13 · Arrow International - Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116…
FDA Device · Class II · 2016-07-13 · Karl Storz Endoscopy - PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical M…
FDA Device · Class II · 2016-07-13 · Medtronic Navigation - Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
FDA Device · Class II · 2016-07-13 · Esaote S P A - Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc
FDA Device · Class II · 2016-07-13 · The Anspach Effort - Medtronic Navigation O-arm 02 surgical x-ray imaging system
FDA Device · Class II · 2016-07-13 · Medtronic Navigation Littleton - Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or oss…
FDA Device · Class II · 2016-07-13 · Musculoskeletal Transplant Foundation - ABG-HM-1 Hummi Micro Draw Blood Transfer Device
FDA Device · Class I · 2016-07-13 · Hummingbird Med - The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the seco…
FDA Device · Class II · 2016-07-13 · Zyto Technologies - Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
FDA Device · Class II · 2016-07-13 · Synthes Usa Products - HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC A…
FDA Device · Class II · 2016-07-13 · Ergoactives - The ZYTO Tower is the input device to program the software with various virtual items
FDA Device · Class II · 2016-07-13 · Zyto Technologies - GE Healthcare, Discovery MR750w
FDA Device · Class II · 2016-07-13 · Ge Healthcare - Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each
FDA Device · Class II · 2016-07-13 · Lifeline First Aid - Covidien Cytosponge Cell Collection Kit
FDA Device · Class II · 2016-07-13 · Covidien - MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3…
FDA Device · Class II · 2016-07-13 · Toshiba American Medical Systems - VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Ge…
FDA Device · Class III · 2016-07-13 · Ortho Clinical Diagnostics - 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors
FDA Device · Class II · 2016-07-13 · Lifeline First Aid - Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17
FDA Device · Class II · 2016-07-13 · Exactech - Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18
FDA Device · Class II · 2016-07-13 · Exactech - Ingenuity Flex, model # 728317
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19
FDA Device · Class II · 2016-07-06 · Carefusion 303 - Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173
FDA Device · Class II · 2016-07-06 · Siemens Medical Solutions Usa - Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) F…
FDA Device · Class II · 2016-07-06 · Siemens Healthcare Diagnostics - Saw Sagittal Catalog Number: ES 300
FDA Device · Class II · 2016-07-06 · Medtronic Sofamor Danek Usa Dallas Distribution - Big Bore Oncology tomography X-ray system scanner, model number 728243
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
FDA Device · Class II · 2016-07-06 · Circulatory Technology - Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system…
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
FDA Device · Class II · 2016-07-06 · Baxter Healthcare - Symbiq Two Channel Infuser
FDA Device · Class II · 2016-07-06 · Hospira
Other years
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