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: M00548440 (XMD P/N 70-0050-B14) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally re…
FDA Device · Class II · 2016-03-02 · Gsi Group - Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) 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: M00548530 (XMD P/N 70-0050-416) 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: M00549430 (XMD P/N 70-0050-D22) 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: M00548650 (XMD P/N 70-0050-G16) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
FDA Device · Class II · 2016-03-02 · Fresenius Medical Care Renal Therapies Group - EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-0050-B24) 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: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, un…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) 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: M00549510 (XMD P/N 70-0050-724) 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: M00548510 (XMD P/N 70-0050-216) The EndoVive 3s Low Profile Balloon is intended to provid…
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 cement…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - Syngo Plaza Picture archiving and communication system
FDA Device · Class II · 2016-03-02 · Siemens Medical Solutions Usa - EndoVive 3s Low Profile Balloon Kits Part Number: M00548550 (XMD P/N 70-0050-616) 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: M00548520 (XMD P/N 70-0050-316) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemente…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - Philips IntelliVue Module Measurement X2 Model: M3002A
FDA Device · Class II · 2016-03-02 · Philips Electronics North America - EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) 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: M00549400 (XMD P/N 70-0050-A22) 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: M00548850 (XMD P/N 70-0050-420) 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-140L, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in…
FDA Device · Class II · 2016-03-02 · Stryker Spine - EndoVive 3s Low Profile Balloon Kits Part Number: M00549520 (XMD P/N 70-0050-824) 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: M00549310 (XMD P/N 70-0050-122) 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: M00548330 (XMD P/N 70-0050-014) 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: M00548580 (XMD P/N 70-0050-916) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Con…
FDA Device · Class II · 2016-03-02 · Centurion Medical Products - EndoVive 3s Low Profile Balloon Kits Part Number: M00548900 (XMD P/N 70-0050-920) 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: M00549600 (XMD P/N 70-0050-G24) 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: M00548610 (XMD P/N 70-0050-C16) 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: M00548490 (XMD P/N 70-0050-G14) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 he…
FDA Device · Class II · 2016-03-02 · Teleflex Medical - Shuttle Select Slip-Cath Catheter
FDA Device · Class I · 2016-03-02 · Cook - Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-0050-820) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) 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: M00548260 (XMD P/N 70-0050-512) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-co…
FDA Device · Class I · 2016-03-02 · Cook - EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-0050-218) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - VERSYS 7.5 INCH BEADED FC 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: M00548920 (XMD P/N 70-0050-B20) 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, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon 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: M00548380 (XMD P/N 70-0050-514) 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: M00548470 (XMD P/N 70-0050-E14) 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: M005489350 (XMD P/N 70-0050-522) The EndoVive 3s Low Profile Balloon is intended to provi…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Stryker, T2 Guidewire, Smooth-Tipped, 2.2 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: M00548800 (XMD P/N 70-0050-F18) 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: M00548220 (XMD P/N 70-0050-112) 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: M00549330 (XMD P/N 70-0050-322) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack
FDA Device · Class III · 2016-03-02 · Sorin Group Usa - Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - EkoSonic Endovascular System, Catalog Number 500-56112
FDA Device · Class II · 2016-03-02 · Ekos - Stryker, Gamma Guide Pin, 4x400 mm 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. CF-Q140L, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00549570 (XMD P/N 70-0050-D24) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and…
FDA Device · Class II · 2016-03-02 · Cook - Evita Infinity V500 Ventilator
FDA Device · Class I · 2016-03-02 · Draeger Medical - EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-0050-E18) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPo…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) 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: M00548270 (XMD P/N 70-0050-612) 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: M00548810 (XMD P/N 70-0050-G18) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/m…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
FDA Device · Class II · 2016-03-02 · Olympus Scientific Solutions Americas - EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) 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-Q140, flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained,…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
FDA Device · Class II · 2016-03-02 · Philips Electronics North America - software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archiv…
FDA Device · Class II · 2016-03-02 · Siemens Medical Solutions Usa - Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm 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: M00549450 (XMD P/N 70-0050-F22) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
FDA Device · Class II · 2016-03-02 · Philips Electronics North America - EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) 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: M00548600 (XMD P/N 70-0050-B16) 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: M00548750 (XMD P/N 70-0050-A18)
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc
FDA Device · Class II · 2016-02-24 · Viewray - EVOLIS Microplate System, Catalog # 89601
FDA Device · Class II · 2016-02-24 · Bio Rad Laboratories - Bond Polymer Refine Red Detection DS9390 kits
FDA Device · Class II · 2016-02-24 · Leica Microsystems - Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6
FDA Device · Class II · 2016-02-24 · Varian Medical Systems - High Flow Irrigation Extender
FDA Device · Class II · 2016-02-24 · Smith And Nephew Endoscopy Div - LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL
FDA Device · Class II · 2016-02-24 · Smith And Nephew - Exactech Acapella One Interbody Fusion Device Parallel
FDA Device · Class II · 2016-02-24 · Exactech - GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5)
FDA Device · Class II · 2016-02-24 · Verathon - Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ul…
FDA Device · Class II · 2016-02-24 · Medtronic - Actuator for angiographic x-ray monitor ceiling suspension system
FDA Device · Class II · 2016-02-24 · Philips Electronics North America - Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra…
FDA Device · Class II · 2016-02-24 · Medtronic - REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units
FDA Device · Class III · 2016-02-24 · C R Bard - CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1
FDA Device · Class III · 2016-02-24 · Lab Vision - Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Univers…
FDA Device · Class II · 2016-02-24 · Medtronic
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)