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.
- Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usa…
FDA Device · Class II · 2020-03-18 · Ehob - RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
FDA Device · Class II · 2020-03-18 · Raysearch Laboratories Ab - Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac proce…
FDA Device · Class II · 2020-03-18 · Medtronic Corevalve - Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
FDA Device · Class II · 2020-03-18 · Braemar Manufacturing - Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103
FDA Device · Class II · 2020-03-18 · Maquet Cardiovascular Us Sales - Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection an…
FDA Device · Class II · 2020-03-18 · Cardinal Health 200 - Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05…
FDA Device · Class II · 2020-03-18 · Arjohuntleigh Polska Sp Z O O - HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced,…
FDA Device · Class I · 2020-03-18 · Heartware - RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
FDA Device · Class II · 2020-03-18 · Raysearch Laboratories Ab - GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
FDA Device · Class II · 2020-03-18 · Verathon - RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
FDA Device · Class II · 2020-03-18 · Raysearch Laboratories Ab - Pedicle Screws, multiple sizes, Article Nos
FDA Device · Class II · 2020-03-18 · Medicrea International - Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids…
FDA Device · Class II · 2020-03-18 · Cardinal Health 200 - RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
FDA Device · Class II · 2020-03-18 · Raysearch Laboratories Ab - HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory…
FDA Device · Class I · 2020-03-18 · Heartware - BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pum…
FDA Device · Class I · 2020-03-18 · Cme America - Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile
FDA Device · Class II · 2020-03-18 · Nextremity Solutions - Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures
FDA Device · Class II · 2020-03-18 · Medtronic Corevalve - QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays
FDA Device · Class II · 2020-03-18 · Qiagen Sciences - Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purp…
FDA Device · Class II · 2020-03-18 · Cardinal Health 200 - RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
FDA Device · Class II · 2020-03-18 · Raysearch Laboratories Ab - VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: T…
FDA Device · Class II · 2020-03-18 · The Binding Site Group - Iliac Screws, multiple sizes, Article Nos
FDA Device · Class II · 2020-03-18 · Medicrea International - RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
FDA Device · Class II · 2020-03-18 · Raysearch Laboratories Ab - NeuraGen Nerve Guide, 7mm diameter, 2cm length
FDA Device · Class III · 2020-03-18 · Integra Lifesciences - Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use,…
FDA Device · Class II · 2020-03-11 · Bard Peripheral Vascular - Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
FDA Device · Class II · 2020-03-11 · Seca - Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
FDA Device · Class II · 2020-03-11 · Invivo - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
FDA Device · Class II · 2020-03-11 · Siemens Healthcare Diagnostics - FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
FDA Device · Class III · 2020-03-11 · Biofire Defense - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use…
FDA Device · Class II · 2020-03-11 · Bard Peripheral Vascular - Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
FDA Device · Class II · 2020-03-11 · Beckman Coulter - Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
FDA Device · Class II · 2020-03-11 · Normand Info S U - SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suit…
FDA Device · Class III · 2020-03-11 · Advanced Bionics - Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
FDA Device · Class II · 2020-03-11 · Baxter Healthcare - Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
FDA Device · Class II · 2020-03-11 · Beckman Coulter - Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vit…
FDA Device · Class II · 2020-03-11 · Beckman Coulter - Kits containing Covidien Force TriVerse Electrosurgical Devices
FDA Device · Class II · 2020-03-11 · Covidien - CareFusion Alaris Pump Module, Model 8100
FDA Device · Class I · 2020-03-11 · Carefusion 303 - Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081
FDA Device · Class II · 2020-03-11 · Covidien - Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, U…
FDA Device · Class II · 2020-03-11 · Stryker - CareFusion Alaris PCA Module, Model 8120
FDA Device · Class I · 2020-03-11 · Carefusion 303 - LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney…
FDA Device · Class II · 2020-03-11 · Organ Recovery Systems - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - PTS Detect Cotinine, Ref
FDA Device · Class II · 2020-03-11 · Polymer Technology Systems - Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single…
FDA Device · Class II · 2020-03-11 · Bard Peripheral Vascular - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an int…
FDA Device · Class II · 2020-03-11 · Vyaire Medical - McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-00…
FDA Device · Class II · 2020-03-11 · Medtronic - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suct…
FDA Device · Class II · 2020-03-11 · Respiratory Therapeutics Group - CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
FDA Device · Class I · 2020-03-11 · Carefusion 303 - Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Us…
FDA Device · Class II · 2020-03-11 · Bard Peripheral Vascular - Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The…
FDA Device · Class II · 2020-03-11 · Siemens Healthcare Diagnostics - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro…
FDA Device · Class II · 2020-03-11 · Beckman Coulter - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is inte…
FDA Device · Class II · 2020-03-11 · Siemens Healthcare Diagnostics - CareFusion Alaris Syringe Module, Model 8110
FDA Device · Class I · 2020-03-11 · Carefusion 303 - Elecsys CA 19-9, Cat
FDA Device · Class II · 2020-03-11 · Roche Diagnostics Operations - AIA-360 Automated Immunoassay Analyzer, Product Code 019945
FDA Device · Class II · 2020-03-11 · Tosoh Bioscience - Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
FDA Device · Class II · 2020-03-11 · Beckman Coulter - DeRoyal Sterile Custom Kits containing Cardinal Health Gowns
FDA Device · Class II · 2020-03-11 · Deroyal Industries Lafollette - RX Daytona Plus (with ISE/without ISE)
FDA Device · Class II · 2020-03-04 · Randox Laboratories - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
FDA Device · Class II · 2020-03-04 · Biomet 3i - MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405H…
FDA Device · Class II · 2020-03-04 · Microvention - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
FDA Device · Class II · 2020-03-04 · Biomet 3i - MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-…
FDA Device · Class II · 2020-03-04 · Microvention - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
FDA Device · Class II · 2020-03-04 · Biomet 3i - ADVIA Chemistry Lipase, Ref
FDA Device · Class II · 2020-03-04 · Siemens Healthcare Diagnostics - MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101H…
FDA Device · Class II · 2020-03-04 · Microvention - MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515…
FDA Device · Class II · 2020-03-04 · Microvention - MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 1…
FDA Device · Class II · 2020-03-04 · Microvention - COHERENCE Oncologist, Model Nos. 07333680 & 07351898
FDA Device · Class II · 2020-03-04 · Siemens Medical Solutions Usa - TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
FDA Device · Class III · 2020-03-04 · Theralase - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
FDA Device · Class II · 2020-03-04 · Biomet 3i - CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
FDA Device · Class II · 2020-03-04 · Biomet 3i - MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 10…
FDA Device · Class II · 2020-03-04 · Microvention - Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
FDA Device · Class II · 2020-03-04 · Medline Industries - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
FDA Device · Class II · 2020-03-04 · Biomet 3i - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
FDA Device · Class II · 2020-03-04 · Biomet 3i - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
FDA Device · Class II · 2020-03-04 · Biomet 3i - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
FDA Device · Class II · 2020-03-04 · Biomet 3i - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
FDA Device · Class II · 2020-03-04 · Biomet 3i - TLC-2000 Therapeutic Medical Laser System
FDA Device · Class III · 2020-03-04 · Theralase - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
FDA Device · Class II · 2020-03-04 · Biomet 3i - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
FDA Device · Class II · 2020-03-04 · Biomet 3i - MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V
FDA Device · Class II · 2020-03-04 · Microvention - Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344
FDA Device · Class II · 2020-03-04 · Breas Medical - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
FDA Device · Class II · 2020-03-04 · Biomet 3i - LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requir…
FDA Device · Class III · 2020-03-04 · Livanova Usa - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
FDA Device · Class II · 2020-03-04 · Biomet 3i - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
FDA Device · Class II · 2020-03-04 · Biomet 3i - MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 18…
FDA Device · Class II · 2020-03-04 · Microvention - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
FDA Device · Class II · 2020-03-04 · Biomet 3i - CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
FDA Device · Class II · 2020-03-04 · Biomet 3i
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