FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space
FDA Device · Class II · 2020-08-19 · Arrow International - VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in…
FDA Device · Class II · 2020-08-19 · Ortho Clinical Diagnostics - STAT KIT, Model SM30
FDA Device · Class II · 2020-08-19 · Hf Acquisition - Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a si…
FDA Device · Class II · 2020-08-19 · Luminex - Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vi…
FDA Device · Class II · 2020-08-12 · Randox Laboratories - Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converti…
FDA Device · Class II · 2020-08-12 · Siemens Medical Solutions Usa - Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snar…
FDA Device · Class II · 2020-08-12 · Boston Scientific - Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted f…
FDA Device · Class II · 2020-08-12 · Boston Scientific - Alaris Pump Module Model 8100
FDA Device · Class I · 2020-08-12 · Carefusion 303 - Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump
FDA Device · Class I · 2020-08-12 · Smiths Medical Asd - Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted f…
FDA Device · Class II · 2020-08-12 · Boston Scientific - Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a…
FDA Device · Class II · 2020-08-12 · Ge Healthcare - BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are sin…
FDA Device · Class II · 2020-08-12 · Boss Instruments - SUTUREFIX ULTRA Suture, Product number 72203855
FDA Device · Class II · 2020-08-12 · Smith And Nephew - Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128…
FDA Device · Class II · 2020-08-12 · Normand Info S U - Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet a…
FDA Device · Class II · 2020-08-12 · Covidien - Medfusion Syringe Pump Model 4000
FDA Device · Class I · 2020-08-12 · Smiths Medical Asd - Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the c…
FDA Device · Class II · 2020-08-12 · Teleflex Medical - Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted f…
FDA Device · Class II · 2020-08-12 · Boston Scientific - Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet an…
FDA Device · Class II · 2020-08-12 · Covidien - Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted f…
FDA Device · Class II · 2020-08-12 · Boston Scientific - Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro…
FDA Device · Class II · 2020-08-12 · Randox Laboratories - Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted f…
FDA Device · Class II · 2020-08-12 · Boston Scientific - Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro d…
FDA Device · Class II · 2020-08-12 · Randox Laboratories - Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualiz…
FDA Device · Class II · 2020-08-12 · Siemens Medical Solutions Usa - Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
FDA Device · Class II · 2020-08-12 · Mako Surgical - SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting…
FDA Device · Class II · 2020-08-12 · Siemens Medical Solutions Usa - Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted f…
FDA Device · Class II · 2020-08-12 · Boston Scientific - Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest c…
FDA Device · Class II · 2020-08-12 · Teleflex Medical - DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
FDA Device · Class II · 2020-08-12 · Siemens Healthcare Diagnostics - Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments
FDA Device · Class II · 2020-08-12 · Sutter Medizintechnik - Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes…
FDA Device · Class II · 2020-08-12 · Medline Industries - SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converti…
FDA Device · Class II · 2020-08-12 · Siemens Medical Solutions Usa - BD MAX SARS-CoV-2 Reagents, Cat
FDA Device · Class II · 2020-08-12 · Becton Dickinson And - Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
FDA Device · Class I · 2020-08-12 · Carefusion 303 - TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
FDA Device · Class II · 2020-08-05 · Chengdu Ai Qin E Commerce - TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
FDA Device · Class II · 2020-08-05 · Chengdu Ai Qin E Commerce - Computed Tomography X-ray System
FDA Device · Class II · 2020-08-05 · Shanghai United Imaging Healthcare - Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct…
FDA Device · Class II · 2020-08-05 · Teleflex Medical - TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
FDA Device · Class II · 2020-08-05 · Chengdu Ai Qin E Commerce - Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and…
FDA Device · Class II · 2020-08-05 · Ion Beam Applications - Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repa…
FDA Device · Class II · 2020-08-05 · Smith And Nephew - ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for…
FDA Device · Class II · 2020-08-05 · Medline Industries - Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct…
FDA Device · Class II · 2020-08-05 · Teleflex Medical - StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locatin…
FDA Device · Class II · 2020-08-05 · Medtronic Navigation - MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures su…
FDA Device · Class II · 2020-08-05 · Synthes Produktions - Computed Tomography X-ray System
FDA Device · Class II · 2020-08-05 · Shanghai United Imaging Healthcare - Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct vi…
FDA Device · Class II · 2020-08-05 · Teleflex Medical - Alinity ci series System Control Module (SCM)
FDA Device · Class II · 2020-08-05 · Abbott And Kg - Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization o…
FDA Device · Class II · 2020-08-05 · Orthopediatrics - TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
FDA Device · Class II · 2020-08-05 · Chengdu Ai Qin E Commerce - ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intend…
FDA Device · Class II · 2020-08-05 · Medline Industries - Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct…
FDA Device · Class II · 2020-08-05 · Teleflex Medical - MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such…
FDA Device · Class II · 2020-08-05 · Synthes - TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
FDA Device · Class II · 2020-08-05 · Chengdu Ai Qin E Commerce - Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct…
FDA Device · Class II · 2020-08-05 · Teleflex Medical - Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone sc…
FDA Device · Class II · 2020-08-05 · Arthrex - Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct…
FDA Device · Class II · 2020-08-05 · Teleflex Medical - TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
FDA Device · Class II · 2020-08-05 · Chengdu Ai Qin E Commerce - Computed Tomography X-ray System
FDA Device · Class II · 2020-08-05 · Shanghai United Imaging Healthcare - TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
FDA Device · Class II · 2020-08-05 · Chengdu Ai Qin E Commerce - Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure a…
FDA Device · Class II · 2020-08-05 · Richard Wolf - InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic I…
FDA Device · Class II · 2020-08-05 · Steris - Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associate…
FDA Device · Class II · 2020-08-05 · Hill Rom - Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with…
FDA Device · Class II · 2020-08-05 · Hill Rom - regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to…
FDA Device · Class II · 2020-08-05 · Resource Optimization And Innovation - Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct…
FDA Device · Class II · 2020-08-05 · Teleflex Medical - Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - PowerLoc MAX Power Injectable Infusion Set
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - LoFric Origo, Tiemann, 16in, FR12 urinary catheters
FDA Device · Class II · 2020-07-29 · Wellspect Healthcare Division Of Dentsply Ih Ab - SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neu…
FDA Device · Class II · 2020-07-29 · Nuvasive - Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (steril…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa - SafeStep Huber Needle Set AllPoints Port Access System
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are…
FDA Device · Class II · 2020-07-29 · Boston Scientific - IntelliVue MX700 patient monitor, model no. 865241
FDA Device · Class II · 2020-07-29 · Philips North America - Safe-T-Centesis 8 Fr Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - SafeStep Huber Needle Set Port Access Kit
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - Safe-T-Centesis 6 Fr Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intende…
FDA Device · Class II · 2020-07-29 · Boston Scientific - Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200 - Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intend…
FDA Device · Class II · 2020-07-29 · Boston Scientific - SafeStep Huber Needle Set myPICK Port Access Kit
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
FDA Device · Class II · 2020-07-29 · Philips North America - Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile…
FDA Device · Class II · 2020-07-29 · Medtronic Sofamor Danek Usa - LoFric Origo, Tiemann, 16in, FR14 urinary catheters
FDA Device · Class II · 2020-07-29 · Wellspect Healthcare Division Of Dentsply Ih Ab - SafeStep Huber Needle Set
FDA Device · Class II · 2020-07-29 · Becton Dickinson And - Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
FDA Device · Class II · 2020-07-29 · Carefusion 2200
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)