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.
- IQon Spectral CT Computed Tomography X-ray system, Model 728332
FDA Device · Class III · 2016-11-23 · Philips Medical Systems Cleveland - CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The Transpac Disposable Straight Pressure Transducer…
FDA Device · Class II · 2016-11-23 · Icu Medical - Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and…
FDA Device · Class II · 2016-11-23 · Siemens Medical Solutions Usa - Transpac¿ IV Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 46112-30NS The Transpac Disposable Straight Pressure Transducer…
FDA Device · Class II · 2016-11-23 · Icu Medical - Brilliance ICT SP Computed Tomography X-ray system, Model 728311
FDA Device · Class III · 2016-11-23 · Philips Medical Systems Cleveland - Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest c…
FDA Device · Class II · 2016-11-23 · Atrium Medical - Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (A…
FDA Device · Class II · 2016-11-23 · Siemens Healthcare Diagnostics - MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47 The Transpac Disposable Straight Pressure Transd…
FDA Device · Class II · 2016-11-23 · Icu Medical - QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable Straight Pressure Tra…
FDA Device · Class II · 2016-11-23 · Icu Medical - SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to prod…
FDA Device · Class II · 2016-11-23 · Siemens Medical Solutions Usa - PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ext…
FDA Device · Class II · 2016-11-23 · Icu Medical - RF MultiGen¿, 0406-900-000
FDA Device · Class III · 2016-11-23 · Stryker Instruments Div - Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-55 The Transpac Disposab…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRO…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODR…
FDA Device · Class II · 2016-11-23 · Icu Medical - 5 Port "OFF" Manifold w/TRANSPAC¿ IV, Item No. 46100-29 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pre…
FDA Device · Class II · 2016-11-23 · Icu Medical - M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer…
FDA Device · Class II · 2016-11-23 · Icu Medical - Dimension Vista IRON Flex reagent cartridges
FDA Device · Class III · 2016-11-23 · Siemens Healthcare Diagnostics - CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pressure Transducer (DSP…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML SQUEEZE FLUSH, MACRODRIP (POL…
FDA Device · Class II · 2016-11-23 · Icu Medical - Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent
FDA Device · Class II · 2016-11-23 · C R Bard - Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo¿ Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63…
FDA Device · Class II · 2016-11-23 · Icu Medical - CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pressur…
FDA Device · Class II · 2016-11-23 · Icu Medical - PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 The Transpac Disposable Straight Pressure Transducer…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Squeeze Flush and 2 Needleless Valves, Item No. 46103-77 The Tr…
FDA Device · Class II · 2016-11-23 · Icu Medical - SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produc…
FDA Device · Class II · 2016-11-23 · Siemens Medical Solutions Usa - TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pressure Transducer (DSP…
FDA Device · Class II · 2016-11-23 · Icu Medical - Cath Lab Kit w/Waste Bag, dyePod¿, Sosa Spike & Syringe, Item No. 46098-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is a…
FDA Device · Class II · 2016-11-23 · Icu Medical - Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, Item No. 46107-68 The Transpac Disposab…
FDA Device · Class II · 2016-11-23 · Icu Medical - OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The Transpac Disposable Straight Pressure Transducer (DSP…
FDA Device · Class II · 2016-11-23 · Icu Medical - PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Tran…
FDA Device · Class II · 2016-11-23 · Icu Medical - Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Osta…
FDA Device · Class II · 2016-11-23 · Beckman Coulter - MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an…
FDA Device · Class II · 2016-11-23 · Icu Medical - OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-48 The Transpac Disposable Straight Pressure Tr…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item…
FDA Device · Class II · 2016-11-23 · Icu Medical - SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25 The Transpac Disposable Straight Pressure Transducer (DSP…
FDA Device · Class II · 2016-11-23 · Icu Medical - Merge PACS software
FDA Device · Class II · 2016-11-23 · Merge Healthcare - DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No. 46063-03 The Transpac Disposable Straight Pressure Transd…
FDA Device · Class II · 2016-11-23 · Icu Medical - Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascul…
FDA Device · Class II · 2016-11-23 · Icu Medical - SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional i…
FDA Device · Class II · 2016-11-23 · Siemens Medical Solutions Usa - TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 The Transpac Disposable Straight P…
FDA Device · Class II · 2016-11-23 · Icu Medical - CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP, 60", DISPOSABLE TRANSDUCER WITH BOND…
FDA Device · Class II · 2016-11-23 · Icu Medical - HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS The Transpac Disposable Stra…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 The Transpac Disposable Straight Pressure Transducer (DSPT…
FDA Device · Class II · 2016-11-23 · Icu Medical - Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an…
FDA Device · Class II · 2016-11-23 · Icu Medical - Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Transpac Disposable Straight Pressure Transducer (DSP…
FDA Device · Class II · 2016-11-23 · Icu Medical - MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50 The Transpac Disposable Straight Pressure Transducer (DSPT…
FDA Device · Class II · 2016-11-23 · Icu Medical - RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrav…
FDA Device · Class II · 2016-11-23 · Icu Medical - 4 Port "ON" Manifold (600 psi) w/4 ft
FDA Device · Class II · 2016-11-23 · Icu Medical - Brilliance iCT Computed Tomography X-ray system, Model 728306
FDA Device · Class III · 2016-11-23 · Philips Medical Systems Cleveland - Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No. 46114-80 The Trans…
FDA Device · Class II · 2016-11-23 · Icu Medical - OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transduce…
FDA Device · Class II · 2016-11-23 · Icu Medical - CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pr…
FDA Device · Class II · 2016-11-23 · Icu Medical - BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014
FDA Device · Class II · 2016-11-23 · C R Bard - ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Transpac Disposable Straight Pressure Transducer (DSP…
FDA Device · Class II · 2016-11-23 · Icu Medical - Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for sin…
FDA Device · Class II · 2016-11-23 · Siemens Medical Solutions Usa - FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sam…
FDA Device · Class II · 2016-11-23 · Inpeco - TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extr…
FDA Device · Class II · 2016-11-23 · Icu Medical - CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pres…
FDA Device · Class II · 2016-11-23 · Icu Medical - COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
FDA Device · Class II · 2016-11-23 · Roche Diagnostics Operations - Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac¿ IV, Waste Bag System and 10 cc Control Syringe, Item No. 46300-11NS Th…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze Flush Device and Needleless Valves, Item No. 46112-13 The Tran…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Blue and Yellow Strip…
FDA Device · Class II · 2016-11-23 · Icu Medical - AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single…
FDA Device · Class II · 2016-11-23 · Siemens Medical Solutions Usa - FlexLab Automation Modules
FDA Device · Class II · 2016-11-23 · Siemens Healthcare Diagnostics - Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No.…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS The Transpac Disposable Straight Pressure Transdu…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straight…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42590-05…
FDA Device · Class II · 2016-11-23 · Icu Medical - MEVION S250 Product Usage: Proton Radiation Therapy
FDA Device · Class II · 2016-11-23 · Mevion Medical Systems - Transpac¿ IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo¿ Flush Devices, Macrodrip (Pole Mount), Item No. 011…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP…
FDA Device · Class II · 2016-11-23 · Icu Medical - MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 The Transpac Disposable Straight Pressure Transducer (DSPT)…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED FOR PATIENT MOUNT), Item No. 42583-05 The Transp…
FDA Device · Class II · 2016-11-23 · Icu Medical - Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…
FDA Device · Class II · 2016-11-23 · Icu Medical - ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is a…
FDA Device · Class II · 2016-11-23 · Icu Medical - Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast Reservoir, Item No. 46095-16 The T…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposable Straight Pressur…
FDA Device · Class II · 2016-11-23 · Icu Medical - MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is a…
FDA Device · Class II · 2016-11-23 · Icu Medical - The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemaker…
FDA Device · Class II · 2016-11-23 · Sorin Group Usa - TRANSPAC¿ IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH AND MACRODRIP (POLE MOUNT), Item No. 42606-05 The Transpac Dis…
FDA Device · Class II · 2016-11-23 · Icu Medical - MEVION S250 Product Usage: Proton Radiation Therapy System
FDA Device · Class II · 2016-11-23 · Mevion Medical Systems - 4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No. 46098-78 The Transpac Disposable Straight Pressure…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 46063-11 The Transpac Disposable Straight Pressure Transducer (DS…
FDA Device · Class II · 2016-11-23 · Icu Medical - QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transpac Disposable Straight Pressure Transducer…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODR…
FDA Device · Class II · 2016-11-23 · Icu Medical - Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needleless Valve, Item No. 46108-36 The Transpac Disposa…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 The Transpac Disposable St…
FDA Device · Class II · 2016-11-23 · Icu Medical - Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DSPT)…
FDA Device · Class II · 2016-11-23 · Icu Medical - Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way Stopcock, Item No. 46098-87NS The Transpac Disposa…
FDA Device · Class II · 2016-11-23 · Icu Medical - Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-03 The Transpac…
FDA Device · Class II · 2016-11-23 · Icu Medical - Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest c…
FDA Device · Class II · 2016-11-23 · Atrium Medical - Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or…
FDA Device · Class II · 2016-11-23 · Atrium Medical - TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straight…
FDA Device · Class II · 2016-11-23 · Icu Medical - PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 The Transpac Disposable Straight Pressure Transducer (DSPT) i…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) is…
FDA Device · Class II · 2016-11-23 · Icu Medical - Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterio…
FDA Device · Class II · 2016-11-23 · Alphatec Spine - TRANSPAC¿ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42632-05 The Transpac Disposa…
FDA Device · Class II · 2016-11-23 · Icu Medical
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)