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.
- BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usa…
FDA Device · Class II · 2020-05-20 · Bd Switzerland Sarl - Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder a…
FDA Device · Class II · 2020-05-20 · Covidien - Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer…
FDA Device · Class II · 2020-05-20 · Covidien - Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accel…
FDA Device · Class II · 2020-05-20 · Inpeco - BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbo…
FDA Device · Class II · 2020-05-20 · Bd Switzerland Sarl - Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte…
FDA Device · Class II · 2020-05-20 · Icu Medical - Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system des…
FDA Device · Class II · 2020-05-20 · Siemens Medical Solutions Usa - Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte…
FDA Device · Class II · 2020-05-20 · Icu Medical - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - iChem¿VELOCITY Urine Chemistry System-
FDA Device · Class II · 2020-05-20 · Beckman Coulter - DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgy…
FDA Device · Class II · 2020-05-20 · Deroyal Industries - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte…
FDA Device · Class II · 2020-05-20 · Icu Medical - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbo…
FDA Device · Class II · 2020-05-20 · Bd Switzerland Sarl - SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine
FDA Device · Class II · 2020-05-20 · C R Bard - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm
FDA Device · Class II · 2020-05-20 · Access Scientific - Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bl…
FDA Device · Class II · 2020-05-20 · Covidien - TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal…
FDA Device · Class II · 2020-05-20 · Cardiac Assist - Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL…
FDA Device · Class II · 2020-05-20 · Covidien - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Ra…
FDA Device · Class II · 2020-05-20 · Ra Medical Systems - Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patien…
FDA Device · Class II · 2020-05-20 · The Magstim - TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique abil…
FDA Device · Class II · 2020-05-20 · Cardiac Assist - Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for…
FDA Device · Class II · 2020-05-20 · Argon Medical Devices - VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The V…
FDA Device · Class II · 2020-05-20 · Ortho Clinical Diagnostics - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
FDA Device · Class II · 2020-05-20 · Becton Dickinson And - Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic…
FDA Device · Class II · 2020-05-20 · Philips North America - Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for u…
FDA Device · Class II · 2020-05-20 · Argon Medical Devices - Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only
FDA Device · Class II · 2020-05-20 · Genicon - Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte…
FDA Device · Class II · 2020-05-20 · Icu Medical - Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Acc…
FDA Device · Class II · 2020-05-20 · Inpeco - CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
FDA Device · Class II · 2020-05-20 · Cuattro - da Vinci X Surgical System
FDA Device · Class II · 2020-05-20 · Intuitive Surgical - Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile
FDA Device · Class II · 2020-05-20 · W L Gore And Associates - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have…
FDA Device · Class II · 2020-05-20 · The Magstim - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circul…
FDA Device · Class II · 2020-05-20 · Cardiac Assist - da Vinci Xi Surgical System
FDA Device · Class II · 2020-05-20 · Intuitive Surgical - Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic…
FDA Device · Class II · 2020-05-20 · Philips North America - EVA Floor Lifts, Model Numbers: 400, 450, 600
FDA Device · Class II · 2020-05-20 · Handicare Ab - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter
FDA Device · Class II · 2020-05-20 · Access Scientific - PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicat…
FDA Device · Class II · 2020-05-20 · Argon Medical Devices - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circula…
FDA Device · Class II · 2020-05-20 · Cardiac Assist - Temporary Snap Abutment Engaging CC RP 1.5 mm
FDA Device · Class II · 2020-05-13 · Nobel Biocare Usa - da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon…
FDA Device · Class II · 2020-05-13 · Intuitive Surgical - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the repla…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-s…
FDA Device · Class II · 2020-05-13 · Ivoclar Vivadent Ag - System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without…
FDA Device · Class II · 2020-05-13 · Siemens Medical Solutions Usa - REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
FDA Device · Class II · 2020-05-13 · Icu Medical - Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-…
FDA Device · Class II · 2020-05-13 · Inpeco - 0.035"(.89mm)x150 cm guidewire
FDA Device · Class I · 2020-05-13 · Argon Medical Devices - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
FDA Device · Class II · 2020-05-13 · Icu Medical - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-…
FDA Device · Class II · 2020-05-13 · Ivoclar Vivadent Ag - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the repla…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA)
FDA Device · Class II · 2020-05-13 · Northgate Technologies - daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are int…
FDA Device · Class II · 2020-05-13 · Intuitive Surgical - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant)
FDA Device · Class II · 2020-05-13 · Nobel Biocare Usa - Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R
FDA Device · Class I · 2020-05-13 · Applied Medical Resources - Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - P…
FDA Device · Class II · 2020-05-13 · Philips Ultrasound - R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124
FDA Device · Class II · 2020-05-13 · Epimed International - Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Num…
FDA Device · Class II · 2020-05-13 · Gentell - Philips Brilliance iCT SP Computed Tomography X-Ray System
FDA Device · Class II · 2020-05-13 · Philips North America - Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only)
FDA Device · Class II · 2020-05-13 · Stryker - Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Num…
FDA Device · Class II · 2020-05-13 · Gentell - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the repla…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext…
FDA Device · Class II · 2020-05-13 · Icu Medical - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - 0.035"(.89mm)x80 cm guidewire
FDA Device · Class I · 2020-05-13 · Argon Medical Devices - Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-st…
FDA Device · Class II · 2020-05-13 · Ivoclar Vivadent Ag - ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion incl…
FDA Device · Class III · 2020-05-13 · Abbott Laboratories - Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407
FDA Device · Class I · 2020-05-13 · Applied Medical Resources - daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are inte…
FDA Device · Class II · 2020-05-13 · Intuitive Surgical - REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)0088…
FDA Device · Class II · 2020-05-13 · Icu Medical - Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound ima…
FDA Device · Class II · 2020-05-13 · Philips Ultrasound - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Num…
FDA Device · Class II · 2020-05-13 · Gentell - Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.…
FDA Device · Class II · 2020-05-13 · Medtronic Navigation - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surg…
FDA Device · Class II · 2020-05-13 · Nuvasive - The Cogent Hemodynamic Monitoring System
FDA Device · Class II · 2020-05-13 · Icu Medical - da Vinci SP Instrument Arm Drape
FDA Device · Class II · 2020-05-13 · Intuitive Surgical - Gentell Honey Hydrogel Hydrogel 4oz
FDA Device · Class II · 2020-05-13 · Gentell - REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
FDA Device · Class II · 2020-05-13 · Icu Medical - Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
FDA Device · Class II · 2020-05-13 · Howmedica Osteonics - Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003
FDA Device · Class II · 2020-05-13 · Delfi Medical Innovations - BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is inten…
FDA Device · Class II · 2020-05-13 · Cme America - Probe, 9 FR AUTOLITH
FDA Device · Class II · 2020-05-13 · Northgate Technologies - ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion i…
FDA Device · Class III · 2020-05-13 · Abbott Laboratories - Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-st…
FDA Device · Class II · 2020-05-13 · Ivoclar Vivadent Ag - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, UDI: (01)00887709016…
FDA Device · Class II · 2020-05-13 · Icu Medical
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)