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.

• Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are…
  FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy
• Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands ar…
  FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy
• IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro…
  FDA Device · Class II · 2017-02-08 · Siemens Healthcare Diagnostics
• SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile
  FDA Device · Class II · 2017-02-08 · Organ Recovery Systems
• Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
  FDA Device · Class II · 2017-02-08 · Zimmer Biomet
• MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
  FDA Device · Class II · 2017-02-08 · Mevion Medical Systems
• Cannulated Drill bit 2.0mm and 2.6 mm
  FDA Device · Class II · 2017-02-08 · Flower Orthopedics
• Spare Disk Remover Module
  FDA Device · Class II · 2017-02-08 · Perkinelmer Life And Analytical Sciences Wallac Oy
• RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures
  FDA Device · Class II · 2017-02-08 · Biom Up
• Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are…
  FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy
• Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are…
  FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy
• Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are…
  FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy
• DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic…
  FDA Device · Class III · 2017-02-01 · Perkinelmer Health Sciences
• Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopc…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F…
  FDA Device · Class II · 2017-02-01 · Philips Electronics North America
• OEC 9800
  FDA Device · Class II · 2017-02-01 · Ge Oec Medical Systems
• Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express Pre…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying huma…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
• Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line c…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immu…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
• Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodia…
  FDA Device · Class II · 2017-02-01 · Baxter Healthcare
• Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean si…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional…
  FDA Device · Class II · 2017-02-01 · Philips Electronics North America
• cobas p 612 pre-analytical system
  FDA Device · Class II · 2017-02-01 · Roche Diagnostics
• Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid fro…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying hum…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
• ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, conta…
  FDA Device · Class II · 2017-02-01 · Mesa Laboratories
• Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blo…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system
  FDA Device · Class II · 2017-02-01 · Ino Therapeutics Dba Ikaria
• Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patien…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Velara Generator with an old Firmware version used with the Philips Integris BH5000
  FDA Device · Class II · 2017-02-01 · Philips Electronics North America
• Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems…
  FDA Device · Class II · 2017-02-01 · Villa Radiology Systems
• Merge Hemo software
  FDA Device · Class II · 2017-02-01 · Merge Healthcare
• Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
  FDA Device · Class II · 2017-02-01 · Philips Electronics North America
• Accu-Chek Connect Diabetes Management App
  FDA Device · Class II · 2017-02-01 · Roche Diabetes Care
• Hitachi Oasis MRI System - C-Spine Coil
  FDA Device · Class II · 2017-02-01 · Hitachi Medical Systems America
• Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures
  FDA Device · Class II · 2017-02-01 · Villa Radiology Systems
• Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve a…
  FDA Device · Class II · 2017-02-01 · On X Life Technologies
• Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
  FDA Device · Class II · 2017-02-01 · Acumedia Manufacturers
• Sekisui Diagnostics Ammonia L3K¿ Assay
  FDA Device · Class II · 2017-02-01 · Sekisui Diagnostics P E I
• Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, intervention…
  FDA Device · Class II · 2017-02-01 · Philips Electronics North America
• AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic i…
  FDA Device · Class III · 2017-02-01 · Perkinelmer Health Sciences
• Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stro…
  FDA Device · Class II · 2017-02-01 · Pentax
• Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
  FDA Device · Class II · 2017-02-01 · Medline Industries
• Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodia…
  FDA Device · Class II · 2017-02-01 · Baxter Healthcare
• Brilliance iCT
  FDA Device · Class II · 2017-02-01 · Philips Medical Systems Cleveland
• Juno DRF
  FDA Device · Class II · 2017-02-01 · Villa Radiology Systems
• SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities
  FDA Device · Class II · 2017-02-01 · Soft Computer Consultants
• Softbank software Product Usage: Decision support software for transfusion service
  FDA Device · Class II · 2017-02-01 · Soft Computer Consultants
• Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (…
  FDA Device · Class II · 2017-02-01 · Roche Diagnostics Operations
• MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in s…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
• Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG s…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
• Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric…
  FDA Device · Class II · 2017-02-01 · Roche Diagnostics Operations
• Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures
  FDA Device · Class II · 2017-02-01 · Villa Radiology Systems
• Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional proce…
  FDA Device · Class II · 2017-02-01 · Philips Electronics North America
• NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230
  FDA Device · Class II · 2017-02-01 · Smiths Medical Asd
• Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional proce…
  FDA Device · Class II · 2017-02-01 · Philips Electronics North America
• OEC 9900 Elite
  FDA Device · Class II · 2017-02-01 · Ge Oec Medical Systems
• Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA a…
  FDA Device · Class III · 2017-02-01 · Perkinelmer Health Sciences
• Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control…
  FDA Device · Class II · 2017-02-01 · Atrium Medical
• Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
• Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 a…
  FDA Device · Class II · 2017-02-01 · The Binding Site Group
• Optilite IgG4 Kit Product Code: LK009.OPT.A
  FDA Device · Class III · 2017-02-01 · The Binding Site Group
• Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic a…
  FDA Device · Class II · 2017-01-25 · Great Basin Scientific
• MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is i…
  FDA Device · Class I · 2017-01-25 · Biomerieux
• AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J
  FDA Device · Class II · 2017-01-25 · Exactech
• Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid…
  FDA Device · Class II · 2017-01-25 · Carestream Health
• Fresenius 2008K@home Series : Hemodialysis System
  FDA Device · Class II · 2017-01-25 · Fresenius Medical Care Renal Therapies Group
• Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random…
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
• Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221
  FDA Device · Class I · 2017-01-25 · Carefusion 303
• AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F008…
  FDA Device · Class II · 2017-01-25 · Endologix
• Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
  FDA Device · Class II · 2017-01-25 · Zimmer Biomet
• Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding s…
  FDA Device · Class I · 2017-01-25 · Bard Peripheral Vascular
• AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550
  FDA Device · Class III · 2017-01-25 · Beckman Coulter
• Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector be…
  FDA Device · Class II · 2017-01-25 · Medacta Usa
• AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovas…
  FDA Device · Class II · 2017-01-25 · Endologix
• Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
• Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15
  FDA Device · Class II · 2017-01-25 · Exactech
• APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid…
  FDA Device · Class II · 2017-01-25 · Baxter Healthcare
• AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endova…
  FDA Device · Class II · 2017-01-25 · Endologix
• AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of pa…
  FDA Device · Class II · 2017-01-25 · Endologix
• Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only
  FDA Device · Class II · 2017-01-25 · Smith And Nephew
• AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovas…
  FDA Device · Class II · 2017-01-25 · Endologix
• AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F S…
  FDA Device · Class II · 2017-01-25 · Endologix
• Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only
  FDA Device · Class II · 2017-01-25 · Smith And Nephew
• Fresenius 2008T Series Hemodialysis System
  FDA Device · Class II · 2017-01-25 · Fresenius Medical Care Renal Therapies Group
• Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perf…
  FDA Device · Class I · 2017-01-25 · Bard Peripheral Vascular
• Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and ana…
  FDA Device · Class II · 2017-01-25 · Dicom Grid
• Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple M…
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
• Fresenius 2008K2 Series : Hemodialysis System
  FDA Device · Class II · 2017-01-25 · Fresenius Medical Care Renal Therapies Group
• Digital RID Plate Reader and Software Product Code: AD400
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
• NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge can…
  FDA Device · Class II · 2017-01-25 · Ultradent Products
• Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit
  FDA Device · Class II · 2017-01-25 · The Binding Site Group
• PREMIER EHEC and PREMIER EHEC Bulk
  FDA Device · Class II · 2017-01-25 · Meridian Bioscience
• RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size…
  FDA Device · Class II · 2017-01-25 · Zimmer Biomet
• Fresenius 2008K Series : Hemodialysis System
  FDA Device · Class II · 2017-01-25 · Fresenius Medical Care Renal Therapies Group
• Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
  FDA Device · Class II · 2017-01-25 · Exactech
• Monaco RTP System
  FDA Device · Class II · 2017-01-25 · Elekta

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)