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.
- EndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-0050-624) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemen…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: s…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548300 (XMD P/N 70-0050-912) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00548630 (XMD P/N 70-0050-E16) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker Aero-AL Impaction handle Catalog Number 48921007
FDA Device · Class II · 2016-03-02 · Stryker Spine - This reagent is for in vitro diagnostic use
FDA Device · Class II · 2016-03-02 · Leica Microsystems - EndoVive 3s Low Profile Balloon Kits Part Number: M00549580 (XMD P/N 70-0050-E24) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Synthes Small Electric Drive (SED)
FDA Device · Class II · 2016-03-02 · The Anspach Effort - GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology…
FDA Device · Class II · 2016-03-02 · Regulatory Insight - Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avas…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548950 (XMD P/N 70-0050-E20) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-0050-D20) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00548480 (XMD P/N 70-0050-F14) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - BD FMC7 FITC: Model 430918
FDA Device · Class III · 2016-03-02 · Becton Dickinson And Bd Biosciences - Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while contro…
FDA Device · Class I · 2016-03-02 · Maquet Cardiovascular Us Sales - Stryker Vitallium Wire (6 Pack) Non Sterile
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polym…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD P/N 70-0050-318) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated cathe…
FDA Device · Class I · 2016-03-02 · Cook - BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP…
FDA Device · Class II · 2016-03-02 · Siemens Healthcare Diagnostics - Philips IntelliVue Measurement Module X1 Model: M3001A
FDA Device · Class II · 2016-03-02 · Philips Electronics North America - EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548400 (XMD P/N 70-0050-714) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548390 (XMD P/N 70-0050-614) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in p…
FDA Device · Class II · 2016-03-02 · Bigwall Enterprises - VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: s…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00548760 (XMD P/N 70-0050-B18) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548700 (XMD P/N 70-0050-518) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cem…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548450 (XMD P/N 70-0050-C14) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548960 (XMD P/N 70-0050-F20) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - Philips Healthcare IntelliVue Info Center iX, A.0 866023
FDA Device · Class II · 2016-03-02 · Philips Electronics North America - EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-0050-618) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-0050-A16) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer variou…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECON…
FDA Device · Class II · 2016-03-02 · Siemens Healthcare Diagnostics - Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286
FDA Device · Class II · 2016-03-02 · Medtronic Neuromodulation - EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-0050-A20) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-0050-520) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobi…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" T…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548560 (XMD P/N 70-0050-716) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - HipLOC CHS Plate/Lag Screw Introducer
FDA Device · Class II · 2016-03-02 · Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - Mammomat Inspiration with Tomosynthesis functionality
FDA Device · Class II · 2016-03-02 · Siemens Medical Solutions Usa - PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is ind…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are i…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549480 (XMD P/N 70-0050-424) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131…
FDA Device · Class II · 2016-03-02 · Cardiac Science - The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner
FDA Device · Class II · 2016-03-02 · Hospira - CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, k…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prost…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet
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