FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of deh…
FDA Device · Class II · 2018-05-16 · Abbott And Kg - ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
FDA Device · Class II · 2018-05-16 · Depuy Orthopaedics - Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020
FDA Device · Class II · 2018-05-16 · Perkinelmer Life And Analytical Sciences Wallac Oy - PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system
FDA Device · Class II · 2018-05-16 · Vygon U - POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-30…
FDA Device · Class II · 2018-05-16 · Beckman Coulter - Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system
FDA Device · Class II · 2018-05-16 · Vygon U - Retractor f/Sciatic Nerve
FDA Device · Class II · 2018-05-16 · Synthes Usa Products - Lipase, Catalog number: LI3837
FDA Device · Class II · 2018-05-16 · Randox Laboratories - ADVIA Centaur¿ HBc IgM
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Dimension Vista Thyroxine (T4) assay
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
FDA Device · Class II · 2018-05-16 · Datascope - IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - IMMULITE ¿ /IMMULITE ¿ 1000 TG
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
FDA Device · Class II · 2018-05-16 · Datascope - BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
FDA Device · Class II · 2018-05-16 · Datascope - Posterior LITE w/ Capio SLIM
FDA Device · Class II · 2018-05-16 · Boston Scientific - Capio CL
FDA Device · Class II · 2018-05-16 · Boston Scientific - Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system
FDA Device · Class II · 2018-05-16 · Vygon U - Capio Open Access Box 4 (Capio OPC)
FDA Device · Class II · 2018-05-16 · Boston Scientific - ADVIA Salicylate (SAL) reagent chemistry assay
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum
FDA Device · Class II · 2018-05-16 · Diagnostic Hybrids - Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation trai…
FDA Device · Class II · 2018-05-16 · Ondamed - Gentle Threads, Interference Screw
FDA Device · Class II · 2018-05-16 · Zimmer Biomet - AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter Product Usage: The AirLife Resuscitation devices are manual…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the te…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
FDA Device · Class II · 2018-05-16 · Datascope - BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
FDA Device · Class II · 2018-05-16 · Datascope - BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
FDA Device · Class II · 2018-05-16 · Datascope - Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system
FDA Device · Class II · 2018-05-16 · Vygon U - AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLife Resuscitation devices are manual resuscitation…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements
FDA Device · Class II · 2018-05-16 · Mako Surgical - IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - NvisionVLE¿ Low-Profile Optical Probe
FDA Device · Class II · 2018-05-16 · Ninepoint Medical - POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Device · Class II · 2018-05-16 · Mhc Medical Products - Gentle Threads, Interference Screw
FDA Device · Class II · 2018-05-16 · Zimmer Biomet - Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the t…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are m…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the ort…
FDA Device · Class II · 2018-05-16 · Depuy Mitek A Johnson And Johnson - AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manual resuscitation dev…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices a…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
FDA Device · Class II · 2018-05-16 · Datascope - Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6…
FDA Device · Class II · 2018-05-16 · Medtronic Sofamor Danek Usa - AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices a…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
FDA Device · Class II · 2018-05-16 · Datascope - ADVIA Centaur¿ DHEA-SO4
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the t…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HK…
FDA Device · Class II · 2018-05-16 · Maquet Cardiopulmonary Ag - ACUSON SC2000 Ultrasound System
FDA Device · Class II · 2018-05-16 · Siemens Medical Solutions Usa - Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the t…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
FDA Device · Class II · 2018-05-16 · Datascope - Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid…
FDA Device · Class II · 2018-05-16 · Cook - BEQ-TOP 22701, Catalog No. 701050790
FDA Device · Class II · 2018-05-16 · Datascope - Uphold Vaginal Support System
FDA Device · Class II · 2018-05-16 · Boston Scientific - ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) i…
FDA Device · Class II · 2018-05-16 · Siemens Medical Solutions Usa - AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The A…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the te…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, i…
FDA Device · Class I · 2018-05-16 · Draeger Medical - Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
FDA Device · Class II · 2018-05-16 · Parker Laboratories - POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Gentle Threads, Interference Screw
FDA Device · Class II · 2018-05-16 · Zimmer Biomet - IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Uphold LITE w/ Capio SLIM
FDA Device · Class II · 2018-05-16 · Boston Scientific - BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
FDA Device · Class II · 2018-05-16 · Datascope - Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorpor…
FDA Device · Class II · 2018-05-16 · Transonic Systems - ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to…
FDA Device · Class II · 2018-05-16 · Microline Surgical - POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom K…
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Capio Standard Box 4 (Capio PC)
FDA Device · Class II · 2018-05-16 · Boston Scientific - AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Res…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fl…
FDA Device · Class II · 2018-05-16 · Cook - ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
FDA Device · Class II · 2018-05-16 · Datascope - BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
FDA Device · Class II · 2018-05-16 · Datascope - AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices ar…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Straumann¿ Emdogain 0.15 ml 5-Pack
FDA Device · Class II · 2018-05-16 · Straumann Manufacturing - POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - Dimension Ammonia (AMM) assay
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Dimension Vista Aspartate Aminotransferase (AST) assay
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid…
FDA Device · Class II · 2018-05-16 · Cook - AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitati…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - PFR Kit- Pinnacle, Posterior
FDA Device · Class II · 2018-05-16 · Boston Scientific - Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resu…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the t…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
FDA Device · Class II · 2018-05-16 · Inpeco - ZYMUTEST HIA MonoStrip IgG
FDA Device · Class II · 2018-05-16 · Hyphen Biomed - IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, in…
FDA Device · Class I · 2018-05-16 · Draeger Medical - EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Device · Class II · 2018-05-16 · Mhc Medical Products - AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization…
FDA Device · Class II · 2018-05-16 · Tornier
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