FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hemato…
FDA Device · Class II · 2019-04-03 · Lw Scientific - Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health car…
FDA Device · Class II · 2019-04-03 · Philips North America - Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is inte…
FDA Device · Class II · 2019-04-03 · Accelerate Diagnostics - Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300,…
FDA Device · Class II · 2019-04-03 · Medical Action Industries - ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Fl…
FDA Device · Class II · 2019-04-03 · Icu Medical - Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system…
FDA Device · Class II · 2019-04-03 · Sanrai International - Vacuum Unit for CATSmart Vacuum Pump
FDA Device · Class II · 2019-04-03 · Fenwal - Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
FDA Device · Class II · 2019-04-03 · Keystone Dental - Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designe…
FDA Device · Class III · 2019-04-03 · Medtronic Cardiac Rhythm And Heart Failure Crhf - JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instru…
FDA Device · Class II · 2019-04-03 · Smith And Nephew - Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as ar…
FDA Device · Class II · 2019-04-03 · Keystone Dental - Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone H…
FDA Device · Class II · 2019-04-03 · Avitus Orthopaedics - MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF,…
FDA Device · Class II · 2019-04-03 · Philips North America - BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data manageme…
FDA Device · Class II · 2019-04-03 · Becton Dickinson And - ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flu…
FDA Device · Class II · 2019-04-03 · Icu Medical - Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone H…
FDA Device · Class II · 2019-04-03 · Avitus Orthopaedics - Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/1…
FDA Device · Class III · 2019-04-03 · Ge Healthcare - Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal…
FDA Device · Class II · 2019-04-03 · Philips North America - JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instru…
FDA Device · Class II · 2019-04-03 · Smith And Nephew - On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseas…
FDA Device · Class II · 2019-04-03 · Cryolife - Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the…
FDA Device · Class I · 2019-04-03 · Maquet Cardiovascular Us Sales - JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instru…
FDA Device · Class II · 2019-04-03 · Smith And Nephew - ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml S…
FDA Device · Class II · 2019-04-03 · Icu Medical - Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended fo…
FDA Device · Class II · 2019-03-27 · Acell - Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celec…
FDA Device · Class III · 2019-03-27 · Cook Medical - Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther T…
FDA Device · Class III · 2019-03-27 · Cook Medical - Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter…
FDA Device · Class III · 2019-03-27 · Cook Medical - Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit
FDA Device · Class II · 2019-03-27 · Convatec - PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coati…
FDA Device · Class III · 2019-03-27 · Agfa N V - Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clin…
FDA Device · Class II · 2019-03-27 · Randox Laboratories - Dimension Vista 500, Analyzer, chemistry Model no. 10284473
FDA Device · Class II · 2019-03-27 · Siemens Healthcare Diagnostics - SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or ge…
FDA Device · Class II · 2019-03-27 · Shimadzu Medical Systems Usa Com - smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
FDA Device · Class II · 2019-03-27 · Smith And Nephew - Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on cli…
FDA Device · Class II · 2019-03-27 · Randox Laboratories - Forceps Blue, disposable, sterile, 100 eaches per sales unit
FDA Device · Class II · 2019-03-27 · Convatec - smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
FDA Device · Class II · 2019-03-27 · Smith And Nephew - Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clin…
FDA Device · Class II · 2019-03-27 · Randox Laboratories - CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
FDA Device · Class II · 2019-03-27 · Ctl Medical - Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
FDA Device · Class II · 2019-03-27 · Siemens Healthcare Diagnostics - FilterFlow Suction Handle CH24, 20 eaches per sales unit
FDA Device · Class II · 2019-03-27 · Convatec - CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
FDA Device · Class II · 2019-03-27 · Ctl Medical - Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of pa…
FDA Device · Class II · 2019-03-27 · Fujifilm Medical Systems U - Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box
FDA Device · Class II · 2019-03-27 · Cp Medical - Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter…
FDA Device · Class III · 2019-03-27 · Cook Medical - Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue
FDA Device · Class II · 2019-03-27 · Covidien - aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone pl…
FDA Device · Class II · 2019-03-27 · Aap Implantate Ag - Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: T…
FDA Device · Class III · 2019-03-27 · Cook Medical - Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit
FDA Device · Class II · 2019-03-27 · Convatec - Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended fo…
FDA Device · Class II · 2019-03-27 · Acell - Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect…
FDA Device · Class III · 2019-03-27 · Cook Medical - Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within th…
FDA Device · Class II · 2019-03-20 · Olympus - AVE 2 Birthing Bed
FDA Device · Class II · 2019-03-20 · Linet Spol S R O - NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product…
FDA Device · Class II · 2019-03-20 · Zimmer Trabecular Metal Technology - Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK
FDA Device · Class II · 2019-03-20 · Ossur Americas - Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML
FDA Device · Class II · 2019-03-20 · Ossur Americas - Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
FDA Device · Class II · 2019-03-20 · Boston Scientific - Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK
FDA Device · Class II · 2019-03-20 · Ossur Americas - NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product…
FDA Device · Class II · 2019-03-20 · Zimmer Trabecular Metal Technology - Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML
FDA Device · Class II · 2019-03-20 · Ossur Americas - Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gast…
FDA Device · Class II · 2019-03-20 · Olympus - Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM
FDA Device · Class II · 2019-03-20 · Ossur Americas - Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
FDA Device · Class II · 2019-03-20 · Boston Scientific - US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compre…
FDA Device · Class II · 2019-03-20 · Us Endoscopy Group - Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment…
FDA Device · Class II · 2019-03-20 · Olympus - Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729…
FDA Device · Class II · 2019-03-20 · Reckitt Benckiser - Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL
FDA Device · Class II · 2019-03-20 · Ossur Americas - Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel
FDA Device · Class II · 2019-03-20 · Ossur Americas - Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment…
FDA Device · Class II · 2019-03-20 · Olympus - AMSCO 5000 Series Washer/Disinfector Model # 5052
FDA Device · Class II · 2019-03-20 · Steris - Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364
FDA Device · Class I · 2019-03-20 · Cook - Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95…
FDA Device · Class II · 2019-03-20 · Reckitt Benckiser - VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only
FDA Device · Class II · 2019-03-20 · Ortho Clinical Diagnostics - Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App
FDA Device · Class II · 2019-03-20 · Ossur Americas - AMSCO 3000 Series Washer/Disinfector Model # 3052
FDA Device · Class II · 2019-03-20 · Steris - BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Pane…
FDA Device · Class II · 2019-03-13 · Becton Dickinson And - Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
FDA Device · Class II · 2019-03-13 · Microbiologics - Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Phy…
FDA Device · Class II · 2019-03-13 · Draegar Medical Systems - Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
FDA Device · Class II · 2019-03-13 · Stryker - Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support o…
FDA Device · Class II · 2019-03-13 · Getinge Us Sales - Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by…
FDA Device · Class II · 2019-03-13 · Siemens Medical Solutions Usa - Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc
FDA Device · Class I · 2019-03-13 · Rvo 2 0 - Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is des…
FDA Device · Class II · 2019-03-13 · Getinge Us Sales - Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue a…
FDA Device · Class II · 2019-03-13 · Stryker Sustainability Solutions - ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or…
FDA Device · Class II · 2019-03-13 · Abbott Laboratories - Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is designed…
FDA Device · Class II · 2019-03-13 · Getinge Us Sales - C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a…
FDA Device · Class II · 2019-03-13 · Pentax - AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibili…
FDA Device · Class II · 2019-03-13 · Maquet Cardiovascular - Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to s…
FDA Device · Class II · 2019-03-13 · Getinge Us Sales - Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatri…
FDA Device · Class II · 2019-03-13 · Draegar Medical Systems - Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Sh…
FDA Device · Class II · 2019-03-13 · Zimmer Biomet - Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily…
FDA Device · Class II · 2019-03-13 · Siemens Medical Solutions Usa - SmartPath to dStream for XR and 3.0T, Model Number 781270
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Ingenia Ambition X, Model Number 781356
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Achieva XR 1.5T/3.0T , Model Number 781253
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - Multiva 1.5T 8 R5, Model Number 781074
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Achieva XR 1.5T/3.0T, Model Number 781153
FDA Device · Class II · 2019-03-06 · Philips Medical Systems Nederlands - AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
FDA Device · Class II · 2019-03-06 · Arrow International - Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
FDA Device · Class II · 2019-03-06 · Terumo Cardiovascular Systems
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)