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.
- IceSeed" 1.5 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code:…
FDA Device · Class II · 2020-12-30 · Ga Health - IcePearl" 2.1 CX 90¿ Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - IceFORCE" 2.1 CX Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of f…
FDA Device · Class II · 2020-12-30 · Baxter Healthcare - IceRod" 1.5 Cryoablation Needle
FDA Device · Class II · 2020-12-30 · Boston Scientific - CryoValve SG Pulmonary Human Heart Valve
FDA Device · Class II · 2020-12-30 · Cryolife - Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
FDA Device · Class II · 2020-12-30 · Nova Ortho Med - DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
FDA Device · Class II · 2020-12-23 · Galt Medical - M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures
FDA Device · Class II · 2020-12-23 · Biomet - K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING…
FDA Device · Class II · 2020-12-23 · Helena Laboratories - DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone
FDA Device · Class II · 2020-12-23 · Biomet - DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease
FDA Device · Class II · 2020-12-23 · Ra Medical Systems - PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of smal…
FDA Device · Class II · 2020-12-23 · Biomet - Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spect…
FDA Device · Class II · 2020-12-23 · Carl Zeiss Meditec Ag - DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples M…
FDA Device · Class II · 2020-12-23 · Enterix - RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Met…
FDA Device · Class II · 2020-12-23 · Biomet - Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
FDA Device · Class II · 2020-12-23 · Biomet - RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Cons…
FDA Device · Class II · 2020-12-23 · Biomet - OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage
FDA Device · Class II · 2020-12-23 · Biomet - DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids…
FDA Device · Class II · 2020-12-23 · Becton Dickinson And - 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110…
FDA Device · Class II · 2020-12-23 · Biomet - HLS Set Advanced, Model: BEQ-HLS 7050 USA
FDA Device · Class II · 2020-12-23 · Maquet Cardiovascular Us Sales - Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non…
FDA Device · Class II · 2020-12-23 · Biomet - Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values…
FDA Device · Class II · 2020-12-23 · Carl Zeiss Meditec Ag - Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended…
FDA Device · Class II · 2020-12-23 · Biomet - DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy
FDA Device · Class II · 2020-12-23 · Medtronic Neuromodulation - DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation
FDA Device · Class II · 2020-12-23 · Biomet - Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556,…
FDA Device · Class II · 2020-12-23 · Biomet - 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 11000979…
FDA Device · Class II · 2020-12-23 · Biomet - RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill
FDA Device · Class II · 2020-12-23 · Biomet - DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case
FDA Device · Class II · 2020-12-23 · Medline Industries - Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
FDA Device · Class II · 2020-12-23 · Zimmer Biomet - Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated…
FDA Device · Class II · 2020-12-23 · Kowa Optimed - DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - Microsurgical Operating Room Tables;7300BX (18-351-70)
FDA Device · Class II · 2020-12-23 · Mizuho America - DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs
FDA Device · Class II · 2020-12-23 · Raysearch Laboratories Ab - 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110…
FDA Device · Class II · 2020-12-23 · Biomet - DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoart…
FDA Device · Class II · 2020-12-23 · Biomet - DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - HLS Set Advanced Model Name: BEQ-HLS 5050 USA
FDA Device · Class II · 2020-12-23 · Maquet Cardiovascular Us Sales - DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human se…
FDA Device · Class II · 2020-12-23 · Roche Diagnostics Operations - EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ul…
FDA Device · Class II · 2020-12-23 · Boston Scientific - Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the f…
FDA Device · Class II · 2020-12-23 · Remote Diagnostic Technologies - Microsurgical Operating Room Tables;7300B (18-350-70)
FDA Device · Class II · 2020-12-23 · Mizuho America - DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
FDA Device · Class II · 2020-12-23 · Synthes Usa Products - (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (…
FDA Device · Class II · 2020-12-23 · Terumo Cardiovascular Systems - MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screen…
FDA Device · Class II · 2020-12-16 · Chromsystems Instruments And Chemicals - Evolut (TM) PRO System
FDA Device · Class II · 2020-12-16 · Medtronic Heart Valves Division - Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate…
FDA Device · Class II · 2020-12-16 · Philips North America - Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures
FDA Device · Class II · 2020-12-16 · Integra Lifesciences - 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmat…
FDA Device · Class II · 2020-12-16 · Chromsystems Instruments And Chemicals - Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac a…
FDA Device · Class II · 2020-12-16 · Shimadzu Medical Systems - Evolut (TM) R System
FDA Device · Class II · 2020-12-16 · Medtronic Heart Valves Division - Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number:…
FDA Device · Class II · 2020-12-16 · Randox Laboratories - Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volume…
FDA Device · Class II · 2020-12-16 · Canon Medical System Usa - MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surge…
FDA Device · Class II · 2020-12-16 · Mani Kiyohara Facility - ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph
FDA Device · Class II · 2020-12-16 · Welch Allyn Mortara - Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device…
FDA Device · Class II · 2020-12-16 · Shimadzu Medical Systems - Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, mul…
FDA Device · Class II · 2020-12-16 · Philips North America - Evolut (TM) PRO+ System
FDA Device · Class II · 2020-12-16 · Medtronic Heart Valves Division - MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screeni…
FDA Device · Class II · 2020-12-16 · Chromsystems Instruments And Chemicals - PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage
FDA Device · Class II · 2020-12-16 · Tissuetech - Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoro…
FDA Device · Class II · 2020-12-16 · Shimadzu Medical Systems - PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage
FDA Device · Class II · 2020-12-16 · Tissuetech - BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry
FDA Device · Class II · 2020-12-16 · Becton Dickinson And Bd Biosciences - MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Re…
FDA Device · Class II · 2020-12-16 · Mani Kiyohara Facility - CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
FDA Device · Class II · 2020-12-16 · Avanos Medical - Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and…
FDA Device · Class II · 2020-12-16 · Spacelabs Healthcare - MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiograph…
FDA Device · Class II · 2020-12-16 · Shimadzu Medical Systems - PROKERA, non-sterile - Product Usage: Biologic corneal bandage
FDA Device · Class II · 2020-12-16 · Tissuetech - Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
FDA Device · Class II · 2020-12-16 · Clinical Innovations - MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screenin…
FDA Device · Class II · 2020-12-16 · Chromsystems Instruments And Chemicals - VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experi…
FDA Device · Class II · 2020-12-16 · Livanova Usa - MAC VU360, Electrocardiograph
FDA Device · Class II · 2020-12-16 · Ge Healthcare - Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument…
FDA Device · Class II · 2020-12-16 · K2m - Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
FDA Device · Class II · 2020-12-16 · Randox Laboratories - CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermitt…
FDA Device · Class II · 2020-12-09 · Cme America - BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen inje…
FDA Device · Class II · 2020-12-09 · Becton Dickinson And - Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC…
FDA Device · Class II · 2020-12-09 · Invacare - REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue,…
FDA Device · Class II · 2020-12-09 · Icu Medical - B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 42525…
FDA Device · Class II · 2020-12-09 · Janus Trade Group - Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasou…
FDA Device · Class II · 2020-12-09 · Olympus - CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precis…
FDA Device · Class II · 2020-12-09 · Cme America - Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the…
FDA Device · Class II · 2020-12-09 · Olympus - MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitor…
FDA Device · Class II · 2020-12-09 · Medtronic
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)