FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar
FDA Device · Class II · 2017-05-31 · Cardinal Health 200 - PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
FDA Device · Class II · 2017-05-31 · Teleflex Medical - Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap
FDA Device · Class III · 2017-05-31 · Medtest Holdings - INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
FDA Device · Class II · 2017-05-31 · Teleflex Medical - Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
FDA Device · Class I · 2017-05-24 · Magellan Diagnostics - PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250,…
FDA Device · Class II · 2017-05-24 · Sorin Group Italia Srl Crf - GP321R
FDA Device · Class II · 2017-05-24 · Aesculap Implant Systems - Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room
FDA Device · Class II · 2017-05-24 · Del Mar Reynolds Medical - GP161R
FDA Device · Class II · 2017-05-24 · Aesculap Implant Systems - Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy
FDA Device · Class II · 2017-05-24 · Mobius Medical Systems - Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum o…
FDA Device · Class II · 2017-05-24 · Beckman Coulter - Triglycerides Reagent (TG 2 x 300), Catalog No. 445850
FDA Device · Class II · 2017-05-24 · Beckman Coulter - SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens…
FDA Device · Class II · 2017-05-24 · Bausch And Lomb Surgical - WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerati…
FDA Device · Class II · 2017-05-24 · Teleflex Medical - Brennen Skin Graft Mesher
FDA Device · Class II · 2017-05-24 · Molnlycke Health Care - enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
FDA Device · Class II · 2017-05-24 · Ortho Clinical Diagnostics - Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Device · Class III · 2017-05-24 · Orthosoft - NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty
FDA Device · Class II · 2017-05-24 · Zimmer Biomet - Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
FDA Device · Class I · 2017-05-24 · Reflow Medical - Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation
FDA Device · Class II · 2017-05-24 · Hitachi Medical Systems America - Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Device · Class II · 2017-05-24 · Orthosoft - Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap
FDA Device · Class III · 2017-05-24 · Medtest Holdings - HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625
FDA Device · Class II · 2017-05-24 · Beckman Coulter - VORTRAN Automatic Resuscitator, VARPlus with Extension Kit
FDA Device · Class II · 2017-05-24 · Vortran Medical Technology 1 - Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617
FDA Device · Class I · 2017-05-24 · Respironics California - ADVIA Centaur Systems Insulin Calibrator
FDA Device · Class II · 2017-05-24 · Siemens Healthcare Diagnostics - OVATIO Models: VR 6250, DR 6550, CRT 6750
FDA Device · Class II · 2017-05-24 · Sorin Group Italia Srl Crf - Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk
FDA Device · Class II · 2017-05-24 · Medical Action Industries - NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 10124…
FDA Device · Class I · 2017-05-24 · Abbott Vascular - Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
FDA Device · Class II · 2017-05-24 · Ziehm Imaging - Salicylate Reagent (SALY 2 x 45), Catalog No. 378194
FDA Device · Class II · 2017-05-24 · Beckman Coulter - Access BR Monitor, Part No. 387620
FDA Device · Class II · 2017-05-24 · Beckman Coulter - NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1…
FDA Device · Class I · 2017-05-24 · Abbott Vascular - Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
FDA Device · Class I · 2017-05-24 · Magellan Diagnostics - Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785
FDA Device · Class II · 2017-05-24 · Beckman Coulter - Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for m…
FDA Device · Class II · 2017-05-24 · Zimmer - Proton therapy system -Proteus 235 aka Proteus Plus
FDA Device · Class II · 2017-05-24 · Ion Beam Applications - ARIES System and ARIES M1 System
FDA Device · Class II · 2017-05-24 · Luminex - Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and…
FDA Device · Class II · 2017-05-24 · Beckman Coulter - Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
FDA Device · Class II · 2017-05-24 · Biomet Microfixation - ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial suscepti…
FDA Device · Class II · 2017-05-24 · Biomerieux - 14 mm Distraction Pin, Exagg Qty: 1 per pack
FDA Device · Class II · 2017-05-24 · Medline Industries - ADVIA Centaur Systems Insulin ReadyPack
FDA Device · Class II · 2017-05-24 · Siemens Healthcare Diagnostics - NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012…
FDA Device · Class I · 2017-05-24 · Abbott Vascular - Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298
FDA Device · Class II · 2017-05-24 · Beckman Coulter - GIZA Vertebral Body Replacement
FDA Device · Class II · 2017-05-24 · Eden Spine Europe - White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk
FDA Device · Class II · 2017-05-24 · Medical Action Industries - 16 mm Distraction Pin, Titanium, Qty: 1 per pack
FDA Device · Class II · 2017-05-24 · Medline Industries - INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9…
FDA Device · Class II · 2017-05-24 · Sorin Group Italia Srl Crf - AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the…
FDA Device · Class II · 2017-05-24 · Abbott Medical Optics Amo - VORTRAN Automatic Resuscitator, VARPlus
FDA Device · Class II · 2017-05-24 · Vortran Medical Technology 1 - 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack
FDA Device · Class II · 2017-05-24 · Medline Industries - GE426R
FDA Device · Class II · 2017-05-24 · Aesculap Implant Systems - 12 mm Distraction Pin, Blunt Qty: 1 per pack
FDA Device · Class II · 2017-05-24 · Medline Industries - 10 mm Distraction Pin, Aggressive Qty: 1 per pack
FDA Device · Class II · 2017-05-24 · Medline Industries - Medi-Therm Hyper/Hypothermia System, MTA7900
FDA Device · Class II · 2017-05-17 · Stryker Medical Division - Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
FDA Device · Class II · 2017-05-17 · Arthrex - Bone Dowell Harvest Tubes
FDA Device · Class II · 2017-05-17 · Zimmer Biomet - Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 7…
FDA Device · Class II · 2017-05-17 · Roche Diagnostics - Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
FDA Device · Class II · 2017-05-17 · Abbott Medical Optics Amo - Healon Pro, Part No. 10270012
FDA Device · Class II · 2017-05-17 · Abbott Medical Optics Amo - Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Produ…
FDA Device · Class II · 2017-05-17 · Zimmer Biomet - Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397
FDA Device · Class II · 2017-05-17 · Greatbatch Medical - PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith…
FDA Device · Class II · 2017-05-17 · Smith And Nephew - Stryker PROFESS Registration Kit
FDA Device · Class II · 2017-05-17 · Stryker Instruments Div - Healon V, Part No. 10290045
FDA Device · Class II · 2017-05-17 · Abbott Medical Optics Amo - Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
FDA Device · Class II · 2017-05-17 · Arthrex - Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
FDA Device · Class II · 2017-05-17 · Medtronic Sofamor Danek Usa - Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
FDA Device · Class II · 2017-05-17 · Arthrex - Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box
FDA Device · Class II · 2017-05-17 · Almore International - CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit
FDA Device · Class II · 2017-05-17 · Coopersurgical - Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
FDA Device · Class II · 2017-05-17 · Arthrex - Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
FDA Device · Class II · 2017-05-17 · Abbott Medical Optics Amo - MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnos…
FDA Device · Class II · 2017-05-17 · Med Hot Thermal Imaging - Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal…
FDA Device · Class II · 2017-05-17 · Mederi Therapeutics - NDI P7 Position Sensor, Stereotaxic Instrument
FDA Device · Class II · 2017-05-17 · Orthosoft - Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
FDA Device · Class II · 2017-05-17 · Abbott Medical Optics Amo - Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
FDA Device · Class II · 2017-05-17 · Arthrex - Healon 5 Pro, Part No. 10270015
FDA Device · Class II · 2017-05-17 · Abbott Medical Optics Amo - Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
FDA Device · Class II · 2017-05-17 · Mentor Texas - Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
FDA Device · Class II · 2017-05-17 · Arthrex - Savaria SL-1000 Stairlift
FDA Device · Class II · 2017-05-17 · Savaria Concord Lifts - Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
FDA Device · Class II · 2017-05-17 · Zimmer Biomet - RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment
FDA Device · Class II · 2017-05-17 · Siemens Healthcare Diagnostics - BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Foot Control without Switches, SC2100 Product Usage: Electric system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Rotating Adult Craniotome Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine
FDA Device · Class III · 2017-05-10 · Zimmer Trabecular Metal Technology - Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - 14cm QD Angle Attachment Product Usage: Product attachment
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide conti…
FDA Device · Class I · 2017-05-10 · Newport Medical Instruments - ADJUSTABLE DRILL GUIDE, BLACK MAX
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product avai…
FDA Device · Class II · 2017-05-10 · Roche Diabetes Care - IMRI AIR CONTROL Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Console, eMax2 Plus Product Usage: Electric system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - 6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - 19cm Attachment, Black Max Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
FDA Device · Class II · 2017-05-10 · Smith And Nephew - Autolube-III with Irrigation Product Usage: Pneumatic system
FDA Device · Class II · 2017-05-10 · The Anspach Effort - Compact Speed Reducer, 60:1
FDA Device · Class II · 2017-05-10 · The Anspach Effort
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)