FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - BOND Polymer Refine Detection Kit, Catalog No. DS9800
FDA Device · Class II · 2019-12-18 · Leica Microsystems - Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm)
FDA Device · Class II · 2019-12-18 · Cp Medical - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for…
FDA Device · Class II · 2019-12-18 · Conformis - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
FDA Device · Class II · 2019-12-18 · Medtronic Navigation - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Medfusion Syringe Pump, Model 4000
FDA Device · Class I · 2019-12-18 · Smiths Medical Asd - Ligamax 5 mm Endoscopic Multiple Clip Applier
FDA Device · Class II · 2019-12-18 · Ethicon Endo Surgery - Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5…
FDA Device · Class II · 2019-12-11 · Stryker Instruments Div - Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 592…
FDA Device · Class II · 2019-12-11 · Stryker Instruments Div - TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain
FDA Device · Class III · 2019-12-11 · Theralase - Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
FDA Device · Class II · 2019-12-11 · Steris - Giraffe OmniBed infant warmer
FDA Device · Class I · 2019-12-11 · Ge Healthcare - Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and…
FDA Device · Class II · 2019-12-11 · Miami Device Solutions - BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill i…
FDA Device · Class II · 2019-12-11 · Brasseler Usa I - Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
FDA Device · Class II · 2019-12-11 · Zimmer Biomet - Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
FDA Device · Class I · 2019-12-11 · Medtronic Neuromodulation - Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile
FDA Device · Class II · 2019-12-11 · Lens Com - Quantam 2000 Electrosurgical Generator, Part number 909075-05
FDA Device · Class II · 2019-12-11 · Coopersurgical - XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439
FDA Device · Class II · 2019-12-11 · Allergan - Giraffe Incubator infant warmer
FDA Device · Class I · 2019-12-11 · Ge Healthcare - Quantam 2000 Electrosurgical Generator, Part number 909075-05W
FDA Device · Class II · 2019-12-11 · Coopersurgical - Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
FDA Device · Class II · 2019-12-11 · Zimmer Biomet - TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain
FDA Device · Class III · 2019-12-11 · Theralase - PANTERA Proximal Humerus Fracture Plate System
FDA Device · Class II · 2019-12-11 · Toby Orthopaedics - EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
FDA Device · Class II · 2019-12-11 · Nddd Medical Technologies - Quantam 2000 Electrosurgical Generator, Part number 909075
FDA Device · Class II · 2019-12-11 · Coopersurgical - Eagle 3000 Sterilizer, small steam sterilizer
FDA Device · Class II · 2019-12-11 · Steris - Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX
FDA Device · Class I · 2019-12-11 · Ge Healthcare - HeartStart XL+ Defibrillator/Monitor, Model 861290
FDA Device · Class II · 2019-12-11 · Philips North America - Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
FDA Device · Class I · 2019-12-11 · Ge Healthcare - EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
FDA Device · Class II · 2019-12-11 · Nddd Medical Technologies - PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
FDA Device · Class II · 2019-12-04 · Bard Peripheral Vascular - SWANSON TRAPEZIUM IMPLANT, Part Number 4520002
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clin…
FDA Device · Class II · 2019-12-04 · Endotronix - In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-…
FDA Device · Class II · 2019-12-04 · Gn Hearing A S - VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
FDA Device · Class II · 2019-12-04 · Boston Scientific - Emerge Monorail PTCA Dilatation Catheter
FDA Device · Class II · 2019-12-04 · Boston Scientific - Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-1032…
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Collagen Reagent, Cat
FDA Device · Class III · 2019-12-04 · Helena Laboratories - Alinity ci Level Sensor, Bulk Solution
FDA Device · Class II · 2019-12-04 · Abbott And Kg - Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
FDA Device · Class II · 2019-12-04 · Abbott And Kg - ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
FDA Device · Class II · 2019-12-04 · Boston Scientific - SWANSON FINGER JOINT #1, Part Number 4700001
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
FDA Device · Class II · 2019-12-04 · Boston Scientific - Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc
FDA Device · Class II · 2019-12-04 · Abbott And Kg - HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040…
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
FDA Device · Class II · 2019-12-04 · Howmedica Osteonics - GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilit…
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body
FDA Device · Class II · 2019-12-04 · Becton Dickinson And - V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
FDA Device · Class II · 2019-12-04 · Vital Scientific N V - 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation…
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
FDA Device · Class II · 2019-12-04 · Boston Scientific - HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - NC Emerge Monorail PTCA Dilatation Catheter
FDA Device · Class II · 2019-12-04 · Boston Scientific - Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile
FDA Device · Class II · 2019-12-04 · Nextremity Solutions - COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861…
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide
FDA Device · Class II · 2019-12-04 · Boston Scientific - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710
FDA Device · Class II · 2019-12-04 · Boston Scientific - Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
FDA Device · Class II · 2019-12-04 · Rocket Medical - Intersomatic JULIET Ti OL cage
FDA Device · Class III · 2019-12-04 · Spineart - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
FDA Device · Class II · 2019-12-04 · Boston Scientific - Various Custom Products, Item Nos
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - BIOMOD PORCOAT HA GLENTRAY
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670
FDA Device · Class II · 2019-12-04 · Boston Scientific - Comprehensive RS Cleat CAP, Item No. 110300
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650
FDA Device · Class II · 2019-12-04 · Boston Scientific - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
FDA Device · Class II · 2019-12-04 · Boston Scientific - FoundationOne CDx test report
FDA Device · Class II · 2019-12-04 · Foundation Medicine - INBONE STEM, TIBIAL, TOP, Part Number 200011901
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows:…
FDA Device · Class II · 2019-12-04 · Beckman Coulter - Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - Atellica CH 930 Analyzer
FDA Device · Class II · 2019-12-04 · Siemens Healthcare Diagnostics - Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm
FDA Device · Class II · 2019-12-04 · Boston Scientific - Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET…
FDA Device · Class II · 2019-12-04 · Gn Hearing A S - Platelet Aggregation Kit, Cat
FDA Device · Class III · 2019-12-04 · Helena Laboratories - LT DISC ULNA - HA/PC
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
FDA Device · Class II · 2019-12-04 · Boston Scientific - SWANSON FINGER JOINT #2, Part Number 4700002
FDA Device · Class II · 2019-12-04 · Wright Medical Technology - Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660
FDA Device · Class II · 2019-12-04 · Boston Scientific - Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
FDA Device · Class II · 2019-12-04 · Boston Scientific - Copeland HA Resurfacing Head, MB/HA EAS Head
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
FDA Device · Class II · 2019-12-04 · Abbott And Kg - Compress, Mini Compress
FDA Device · Class II · 2019-12-04 · Zimmer Biomet - Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The…
FDA Device · Class II · 2019-12-04 · Spectranetics
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)