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.
- VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
FDA Device · Class II · 2020-02-05 · Vitreq Bv - JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or s…
FDA Device · Class II · 2020-02-05 · Haemonetics - CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the…
FDA Device · Class II · 2020-02-05 · Haemonetics - GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures…
FDA Device · Class II · 2020-02-05 · Collagen Matrix - JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and process…
FDA Device · Class II · 2020-02-05 · Haemonetics - VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584
FDA Device · Class II · 2020-02-05 · Vitreq Bv - Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed duri…
FDA Device · Class II · 2020-02-05 · Haemonetics - VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
FDA Device · Class II · 2020-02-05 · Vitreq Bv - Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus ner…
FDA Device · Class II · 2020-02-05 · Livanova Usa - 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to…
FDA Device · Class II · 2020-02-05 · Synthes - VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621
FDA Device · Class II · 2020-02-05 · Vitreq Bv - ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgi…
FDA Device · Class II · 2020-02-05 · Zimmer Biomet - Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
FDA Device · Class II · 2020-02-05 · Arthrex - CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the…
FDA Device · Class II · 2020-02-05 · Haemonetics - JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing o…
FDA Device · Class II · 2020-02-05 · Haemonetics - GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a…
FDA Device · Class II · 2020-02-05 · Collagen Matrix - CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery an…
FDA Device · Class II · 2020-02-05 · Haemonetics - EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from…
FDA Device · Class II · 2020-02-05 · Energetiq Technology - Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584)
FDA Device · Class II · 2020-02-05 · Bard Peripheral Vascular - RayStation stand-alone software treatment planning system
FDA Device · Class II · 2020-02-05 · Raysearch Laboratories Ab - Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the…
FDA Device · Class II · 2020-02-05 · Haemonetics - BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-01000…
FDA Device · Class II · 2020-02-05 · Mindray Ds Usa - Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is…
FDA Device · Class II · 2020-02-05 · Exactech - AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is i…
FDA Device · Class II · 2020-02-05 · Radiometer Medical Aps - Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number…
FDA Device · Class II · 2020-02-05 · Roi Cps - Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Device · Class II · 2020-01-29 · Palodex Group Oy - Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
FDA Device · Class II · 2020-01-29 · Paltop Advanced Dental Solutions - Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
FDA Device · Class II · 2020-01-29 · Siemens Healthcare Diagnostics - PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems - TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
FDA Device · Class II · 2020-01-29 · Acclarent - KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Device · Class II · 2020-01-29 · Palodex Group Oy - PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems - Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
FDA Device · Class II · 2020-01-29 · Isopure - Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images
FDA Device · Class II · 2020-01-29 · Koios Medical - Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref
FDA Device · Class II · 2020-01-29 · Imactis - Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support…
FDA Device · Class I · 2020-01-29 · Ge Healthcare - Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Device · Class II · 2020-01-29 · Palodex Group Oy - Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Device · Class II · 2020-01-29 · Isopure - Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
FDA Device · Class II · 2020-01-29 · Isopure - VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a…
FDA Device · Class II · 2020-01-29 · Greiner Bio One North America - TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
FDA Device · Class II · 2020-01-29 · Acclarent - Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
FDA Device · Class II · 2020-01-29 · Siemens Healthcare Diagnostics - Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Device · Class II · 2020-01-29 · Palodex Group Oy - Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
FDA Device · Class II · 2020-01-29 · Medicrea International - Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems - Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare inf…
FDA Device · Class II · 2020-01-29 · Ge Healthcare - Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems - Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support…
FDA Device · Class I · 2020-01-29 · Ge Healthcare - Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
FDA Device · Class II · 2020-01-29 · Medicrea International - Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia
FDA Device · Class II · 2020-01-29 · Arrow International - Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
FDA Device · Class II · 2020-01-29 · Arrow International - Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
FDA Device · Class II · 2020-01-29 · Siemens Healthcare Diagnostics - TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
FDA Device · Class II · 2020-01-29 · Acclarent - iChem VELOCITY Urine Chemistry Analyzer
FDA Device · Class II · 2020-01-29 · Beckman Coulter - Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile
FDA Device · Class II · 2020-01-22 · St Jude Medical Cardiac Rhythm Management Division - CARESCAPE Respiratory Module E-sCOVX
FDA Device · Class I · 2020-01-22 · Ge Healthcare - Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam…
FDA Device · Class II · 2020-01-22 · Carestream Health - Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
FDA Device · Class III · 2020-01-22 · Teleflex Medical - Airway Gas Option N-CAiO
FDA Device · Class I · 2020-01-22 · Ge Healthcare - CARESCAPE Respiratory Module E-sCAiOVE
FDA Device · Class I · 2020-01-22 · Ge Healthcare - LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad
FDA Device · Class II · 2020-01-22 · Physio Control - ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code…
FDA Device · Class II · 2020-01-22 · Coopersurgical - BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The devi…
FDA Device · Class II · 2020-01-22 · Flexicare Medical - Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to e…
FDA Device · Class II · 2020-01-22 · Microbiologics - Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and…
FDA Device · Class II · 2020-01-22 · Degania Silicone - Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catal…
FDA Device · Class II · 2020-01-22 · Howmedica Osteonics - CARESCAPE Respiratory Module E-sCAiOV
FDA Device · Class I · 2020-01-22 · Ge Healthcare - BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055…
FDA Device · Class II · 2020-01-22 · Flexicare Medical - CARESCAPE Respiratory Module E-sCO
FDA Device · Class I · 2020-01-22 · Ge Healthcare - CARESCAPE Respiratory Module E-sCAiOE
FDA Device · Class I · 2020-01-22 · Ge Healthcare - Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00
FDA Device · Class II · 2020-01-22 · Suntech Medical - Siemens ARTIS pheno, Model # 10849000
FDA Device · Class II · 2020-01-22 · Siemens Medical Solutions Usa - CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administr…
FDA Device · Class II · 2020-01-22 · Caire - Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-2…
FDA Device · Class II · 2020-01-22 · Cook - LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
FDA Device · Class II · 2020-01-22 · Physio Control - QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699
FDA Device · Class II · 2020-01-22 · Edwards Lifesciences - BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The…
FDA Device · Class II · 2020-01-22 · Flexicare Medical - Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR
FDA Device · Class II · 2020-01-22 · Riverpoint Medical - CARESCAPE Respiratory Module E-sCAiO
FDA Device · Class I · 2020-01-22 · Ge Healthcare - BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (…
FDA Device · Class II · 2020-01-22 · Flexicare Medical - Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal
FDA Device · Class II · 2020-01-22 · Trilliant Surgical - Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
FDA Device · Class III · 2020-01-22 · Teleflex Medical - Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000
FDA Device · Class II · 2020-01-15 · Intersurgical - Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
FDA Device · Class II · 2020-01-15 · Nextremity Solutions - Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usag…
FDA Device · Class II · 2020-01-15 · Stryker - Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
FDA Device · Class II · 2020-01-15 · Abbott Medical - Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030
FDA Device · Class II · 2020-01-15 · Intersurgical - ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Impla…
FDA Device · Class II · 2020-01-15 · Implant Direct Sybron Manufacturing - Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031
FDA Device · Class II · 2020-01-15 · Intersurgical - Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303
FDA Device · Class II · 2020-01-15 · Avanos Medical - Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000
FDA Device · Class II · 2020-01-15 · Intersurgical - Cios Alpha, Model Number 10308191
FDA Device · Class II · 2020-01-15 · Siemens Medical Solutions Usa - Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluid…
FDA Device · Class II · 2020-01-15 · Baxter Healthcare - Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
FDA Device · Class II · 2020-01-15 · Nextremity Solutions - LightPod Neo Lasers
FDA Device · Class II · 2020-01-15 · Aerolase - Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of…
FDA Device · Class II · 2020-01-15 · Stryker - Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic S…
FDA Device · Class II · 2020-01-15 · Medacta Usa - ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8…
FDA Device · Class II · 2020-01-15 · Baxter Healthcare - ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Impla…
FDA Device · Class II · 2020-01-15 · Implant Direct Sybron Manufacturing - Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are…
FDA Device · Class II · 2020-01-15 · Abbott Medical
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)