FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System)
FDA Device · Class II · 2021-03-17 · Brainlab Ag - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabe…
FDA Device · Class II · 2021-03-17 · Siemens Healthcare Diagnostics - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of ant…
FDA Device · Class II · 2021-03-17 · Tosoh Bioscience - Thread-like wire marker
FDA Device · Class II · 2021-03-17 · Somatex Medical Technologies - CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
FDA Device · Class II · 2021-03-17 · Medtronic Vascular - ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction…
FDA Device · Class II · 2021-03-17 · Draeger Medical - CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary e…
FDA Device · Class II · 2021-03-17 · Physio Control - Valiant Navion Thoracic Stent Graft System
FDA Device · Class I · 2021-03-17 · Medtronic Vascular - CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervical…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with wat…
FDA Device · Class II · 2021-03-17 · Sunstar Americas - Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
FDA Device · Class II · 2021-03-17 · Medtronic Vascular - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - System INFX-8000V
FDA Device · Class II · 2021-03-17 · Canon Medical System Usa - Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
FDA Device · Class II · 2021-03-17 · Howmedica Osteonics - CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - System INFX-8000C
FDA Device · Class II · 2021-03-17 · Canon Medical System Usa - CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
FDA Device · Class II · 2021-03-17 · Medtronic Vascular - CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduc…
FDA Device · Class II · 2021-03-17 · Draeger Medical - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C
FDA Device · Class III · 2021-03-17 · Orasure Technologies - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - System INFX-8000F
FDA Device · Class II · 2021-03-17 · Canon Medical System Usa - Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
FDA Device · Class II · 2021-03-17 · Thermo Fisher Scientific - Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
FDA Device · Class II · 2021-03-17 · Medtronic Vascular - CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed t…
FDA Device · Class II · 2021-03-17 · Insulet - CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conductio…
FDA Device · Class II · 2021-03-17 · Draeger Medical - CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical f…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fi…
FDA Device · Class II · 2021-03-17 · Rti Surgical Dba Pioneer Surgical Technology - VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction o…
FDA Device · Class II · 2021-03-17 · Draeger Medical - Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting h…
FDA Device · Class II · 2021-03-10 · Siemens Medical Solutions Usa - Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
FDA Device · Class II · 2021-03-10 · Boston Scientific - BioFire BCID2 Panel
FDA Device · Class II · 2021-03-10 · Biofire Diagnostics - ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during ar…
FDA Device · Class II · 2021-03-10 · Bovie Medical - Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualifi…
FDA Device · Class II · 2021-03-10 · Shanghai United Imaging Healthcare - Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO
FDA Device · Class II · 2021-03-10 · Renovo - Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that…
FDA Device · Class II · 2021-03-10 · G And H Wire - The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Number…
FDA Device · Class II · 2021-03-10 · Baxter Healthcare - Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310
FDA Device · Class II · 2021-03-10 · Boston Scientific - Gram-Negative Bacteria And Associated Resistance Markers
FDA Device · Class II · 2021-03-10 · Biofire Diagnostics - Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190
FDA Device · Class II · 2021-03-10 · Boston Scientific - HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation
FDA Device · Class II · 2021-03-10 · Hamilton - Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2…
FDA Device · Class II · 2021-03-10 · Coopersurgical - ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System
FDA Device · Class I · 2021-03-10 · Acist Medical Systems - TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag
FDA Device · Class II · 2021-03-10 · Johnson And Johnson Surgical Vision - Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during…
FDA Device · Class II · 2021-03-10 · Bovie Medical - HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthr…
FDA Device · Class II · 2021-03-10 · Bovie Medical - WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
FDA Device · Class II · 2021-03-10 · Nihon Kohden America - Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
FDA Device · Class II · 2021-03-10 · Barco N V - Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blad…
FDA Device · Class II · 2021-03-03 · Deroyal Industries - OT1000 Series Orthopedic Surgical Tables
FDA Device · Class II · 2021-03-03 · Steris - ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumope…
FDA Device · Class II · 2021-03-03 · Northgate Technologies - CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedu…
FDA Device · Class II · 2021-03-03 · Deroyal Industries - S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydro…
FDA Device · Class III · 2021-03-03 · Medline Industries - Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via…
FDA Device · Class II · 2021-03-03 · Covidien - VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWe…
FDA Device · Class II · 2021-03-03 · Ortho Clinical Diagnostics - Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebra…
FDA Device · Class II · 2021-03-03 · Natus Manufacturing - PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used onl…
FDA Device · Class II · 2021-03-03 · Respironics California - ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for singl…
FDA Device · Class II · 2021-03-03 · Siemens Medical Solutions Usa - Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and…
FDA Device · Class II · 2021-03-03 · Smiths Medical Asd - Infusion Pump
FDA Device · Class II · 2021-03-03 · Baxter Healthcare - Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention medi…
FDA Device · Class II · 2021-03-03 · Northgate Technologies - Slush + Warmer Disc Drape
FDA Device · Class II · 2021-03-03 · Ecolab - Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw…
FDA Device · Class II · 2021-03-03 · Deroyal Industries - ENROUTE Transcarotid Stent System REF SR-XXYY-CS
FDA Device · Class II · 2021-03-03 · Silk Road Medical - AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medic…
FDA Device · Class II · 2021-02-24 · Sky Medical Supplies And Equipments - Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 2…
FDA Device · Class II · 2021-02-24 · Medtronic Neurosurgery - Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixati…
FDA Device · Class II · 2021-02-24 · Biomet - Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay inten…
FDA Device · Class II · 2021-02-24 · Confirm Biosciences - Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay…
FDA Device · Class II · 2021-02-24 · Confirm Biosciences - Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for…
FDA Device · Class II · 2021-02-24 · Baxter Healthcare - BD Hypodermic Syringe 10 ml, eccentric tip
FDA Device · Class II · 2021-02-24 · Becton Dickinson And - Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit
FDA Device · Class I · 2021-02-24 · Combat Medical Systems
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)