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.
- Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal…
FDA Device · Class II · 2020-12-30 · Integra Lifesciences - Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt…
FDA Device · Class II · 2020-12-30 · Integra Lifesciences - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administra…
FDA Device · Class II · 2020-12-30 · Baxter Healthcare - Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS…
FDA Device · Class II · 2020-12-30 · Haag Streit Usa - Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102…
FDA Device · Class II · 2020-12-30 · Ga Health - IceSeed" 1.5 Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product…
FDA Device · Class II · 2020-12-30 · Ga Health - Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261
FDA Device · Class II · 2020-12-30 · Icu Medical - Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
FDA Device · Class II · 2020-12-30 · Ga Health - Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
FDA Device · Class II · 2020-12-30 · Icu Medical - PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only,…
FDA Device · Class II · 2020-12-30 · Prytime Medical Devices - IceSphere" 1.5 CX 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
FDA Device · Class II · 2020-12-30 · Biomet - IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011
FDA Device · Class II · 2020-12-30 · Icu Medical - IceSphere" 1.5 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Gui…
FDA Device · Class I · 2020-12-30 · Cook - Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Gui…
FDA Device · Class I · 2020-12-30 · Cook - IcePearl" 2.1 CX Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - IcePearl" 2.1 CX L 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceSphere" 1.5 Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
FDA Device · Class II · 2020-12-30 · Ga Health - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administra…
FDA Device · Class II · 2020-12-30 · Baxter Healthcare - APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration t…
FDA Device · Class II · 2020-12-30 · B Braun Medical - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administra…
FDA Device · Class II · 2020-12-30 · Baxter Healthcare - IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿
FDA Device · Class II · 2020-12-30 · Boston Scientific - Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
FDA Device · Class II · 2020-12-30 · Ga Health - Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25
FDA Device · Class II · 2020-12-30 · Icu Medical - IceSphere" 1.5 Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
FDA Device · Class II · 2020-12-30 · Icu Medical - Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction
FDA Device · Class II · 2020-12-30 · Conmed - Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8…
FDA Device · Class II · 2020-12-30 · Ga Health - IceRod" He-Thaw Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
FDA Device · Class II · 2020-12-30 · Ga Health - 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01
FDA Device · Class II · 2020-12-30 · Icu Medical - APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration t…
FDA Device · Class II · 2020-12-30 · B Braun Medical - Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave
FDA Device · Class II · 2020-12-30 · Ga Health - IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceFORCE" 2.1 CX 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Spinal Rod Cutter, Item number 00392500200
FDA Device · Class II · 2020-12-30 · Zimmer Biomet - APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration t…
FDA Device · Class II · 2020-12-30 · B Braun Medical - 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011
FDA Device · Class II · 2020-12-30 · Icu Medical - IceSphere" 1.5 S 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glut…
FDA Device · Class II · 2020-12-30 · Siemens Healthcare Diagnostics - Three IceFORCE" 2.1 CX Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Five IceSphere" Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01
FDA Device · Class II · 2020-12-30 · Icu Medical - Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - IceRod" 1.5 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceRod" Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceFORCE" 2.1 CX Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC
FDA Device · Class II · 2020-12-30 · Icu Medical - IceRod" 1.5 i-Thaw" Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - Spinning Spiros, Closed Male Luer, REF: 060-CH2000S
FDA Device · Class II · 2020-12-30 · Icu Medical - Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102
FDA Device · Class III · 2020-12-30 · Applied Medical Technology - 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01
FDA Device · Class II · 2020-12-30 · Icu Medical - IceRod" 1.5 PLUS 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications
FDA Device · Class II · 2020-12-30 · Ge Healthcare - MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the s…
FDA Device · Class II · 2020-12-30 · Beckman Coulter - IceRod" 1.5 PLUS Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - Five IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centri…
FDA Device · Class II · 2020-12-30 · Hardy Diagnostics - 3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003
FDA Device · Class II · 2020-12-30 · Icu Medical - Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / E…
FDA Device · Class II · 2020-12-30 · Ga Health - Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - CryoPatch SG Pulmonary Human Cardiac Patch
FDA Device · Class II · 2020-12-30 · Cryolife - IceSeed" Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
FDA Device · Class II · 2020-12-30 · Icu Medical - Three IcePearl" 2.1 CX Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101…
FDA Device · Class II · 2020-12-30 · Ga Health - IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceRod" 1.5 MRI 90¿ Cryoablation Needle¿
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceRod" 1.5 CX 90¿ Cryoablation Needle¿
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceRod" 1.5 MRI Cryoablation Needle¿
FDA Device · Class II · 2020-12-30 · Boston Scientific - Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-g…
FDA Device · Class II · 2020-12-30 · Siemens Healthcare Diagnostics - IceSeed" Prostate Cryoablation Kit
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the st…
FDA Device · Class II · 2020-12-30 · Biocomposites - Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction
FDA Device · Class II · 2020-12-30 · Conmed - Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheaths are intended to in…
FDA Device · Class I · 2020-12-30 · Cook - Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography ap…
FDA Device · Class II · 2020-12-30 · Ge Healthcare - IceSphere" 1.5 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceSeed" 1.5 MRI Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - IcePearl" 2.1 CX Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific
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)