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.
- Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and co…
FDA Device · Class II · 2017-04-05 · Merge Healthcare - Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative
FDA Device · Class II · 2017-04-05 · Streck - Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Proteus 235
FDA Device · Class II · 2017-04-05 · Ion Beam Applications - Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended t…
FDA Device · Class II · 2017-04-05 · Zimmer Biomet Spine - Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer
FDA Device · Class II · 2017-04-05 · Molded Products - Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Prosound F75 or F75 The Hitachi Aloka Medical, Ltd
FDA Device · Class II · 2017-04-05 · Hitachi Aloka Medical - Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
FDA Device · Class II · 2017-04-05 · Baxter Healthcare - Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pne…
FDA Device · Class II · 2017-04-05 · Focus Diagnostics - Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila
FDA Device · Class II · 2017-04-05 · Focus Diagnostics - Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, commu…
FDA Device · Class II · 2017-04-05 · Siemens Medical Solutions Usa - Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU
FDA Device · Class II · 2017-04-05 · Resource Optimization And Innovation - Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32
FDA Device · Class II · 2017-03-29 · Biomerieux - CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provi…
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - Alaris System PC unit, model no. 8000 and 8015
FDA Device · Class II · 2017-03-29 · Carefusion 303 - Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - ARTISTE" MV System
FDA Device · Class II · 2017-03-29 · Siemens Medical Solutions Usa - ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256
FDA Device · Class II · 2017-03-29 · Biomerieux - Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates
FDA Device · Class II · 2017-03-29 · Zimmer Biomet - ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low)
FDA Device · Class II · 2017-03-29 · Biomerieux - Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by comput…
FDA Device · Class II · 2017-03-29 · Philips Medical Systems Cleveland - Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by compute…
FDA Device · Class II · 2017-03-29 · Philips Medical Systems Cleveland - ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low)
FDA Device · Class II · 2017-03-29 · Biomerieux - Hitachi Echelon MRI System
FDA Device · Class II · 2017-03-29 · Hitachi Medical Systems America - EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs)
FDA Device · Class II · 2017-03-29 · Haag Streit Usa - Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI
FDA Device · Class II · 2017-03-29 · Merge Healthcare - Poly Component Trial, CR, packaged in the following sizes and configurations: a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 b) Poly…
FDA Device · Class II · 2017-03-29 · Medtronic Sofamor Danek Usa - Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatm…
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant rad…
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low)
FDA Device · Class II · 2017-03-29 · Biomerieux - Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled m…
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - ARTIS Q, Interventional Fluroscopic x-ray system
FDA Device · Class II · 2017-03-29 · Siemens Medical Solutions Usa - LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
FDA Device · Class II · 2017-03-29 · Tearscience - Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( wa…
FDA Device · Class II · 2017-03-29 · Ohmeda Medical - ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
FDA Device · Class II · 2017-03-29 · Siemens Medical Solutions Usa - ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256
FDA Device · Class II · 2017-03-29 · Biomerieux
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