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.
- These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Pro…
FDA Device · Class II · 2021-12-29 · Hill Rom - VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
FDA Device · Class II · 2021-12-29 · Civco Medical Instruments - Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery
FDA Device · Class II · 2021-12-29 · Beaver Visitec International - WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
FDA Device · Class I · 2021-12-29 · Cardiovascular Systems - regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles
FDA Device · Class II · 2021-12-29 · Roi Cps - Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref
FDA Device · Class II · 2021-12-29 · Medline Industries Northfield - VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
FDA Device · Class II · 2021-12-29 · Civco Medical Instruments - Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430
FDA Device · Class II · 2021-12-29 · Wright Medical Technology - Leica Microsystems M220 F12 Microscope Systems
FDA Device · Class II · 2021-12-29 · Leica Microsystems - Torosa Saline-Filled Testicular Prosthesis (Size Small)
FDA Device · Class II · 2021-12-29 · Coloplast Manufacturing Us - Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery
FDA Device · Class II · 2021-12-29 · Beaver Visitec International - VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
FDA Device · Class II · 2021-12-29 · Civco Medical Instruments - Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundl…
FDA Device · Class II · 2021-12-29 · Medtronic Navigation - Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm
FDA Device · Class II · 2021-12-29 · Wright Medical Technology - Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery
FDA Device · Class II · 2021-12-29 · Beaver Visitec International - Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery
FDA Device · Class II · 2021-12-29 · Beaver Visitec International - SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
FDA Device · Class II · 2021-12-29 · Beckman Coulter - Skinny Needle with Chiba Tip
FDA Device · Class II · 2021-12-29 · Cook - TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z
FDA Device · Class II · 2021-12-29 · Acclarent - Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery
FDA Device · Class II · 2021-12-29 · Beaver Visitec International - VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
FDA Device · Class II · 2021-12-29 · Civco Medical Instruments - Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applicat…
FDA Device · Class II · 2021-12-29 · Philips North America - Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm
FDA Device · Class II · 2021-12-29 · Maquet Cardiovascular - Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
FDA Device · Class II · 2021-12-29 · Stradis Medical - Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery
FDA Device · Class II · 2021-12-29 · Beaver Visitec International - Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software
FDA Device · Class I · 2021-12-29 · Medtronic Navigation - Wright Medical Technology Inc
FDA Device · Class II · 2021-12-29 · Wright Medical Technology - Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
FDA Device · Class II · 2021-12-22 · Cardinal Health - Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce th…
FDA Device · Class II · 2021-12-22 · Cook - Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
FDA Device · Class II · 2021-12-22 · Xstrahl - BioGlue Surgical Adhesive, Model BG3510-5-G
FDA Device · Class II · 2021-12-22 · Cryolife - Cardiosave Rescue IntraAortic Balloon Pump
FDA Device · Class I · 2021-12-22 · Datascope - activforce 2 package labeling: Model: Activ5-M R 201-200563
FDA Device · Class II · 2021-12-22 · Activbody - Cardiosave Hybrid IntraAortic Balloon Pump
FDA Device · Class I · 2021-12-22 · Datascope - Neuro Convenience Kit
FDA Device · Class II · 2021-12-22 · Medline Industries - MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane
FDA Device · Class II · 2021-12-22 · Mentor Texas - smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
FDA Device · Class II · 2021-12-22 · Smith And Nephew - smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
FDA Device · Class II · 2021-12-22 · Smith And Nephew - SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
FDA Device · Class II · 2021-12-22 · Cardinal Health - Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
FDA Device · Class II · 2021-12-22 · Cardinal Health - Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
FDA Device · Class II · 2021-12-22 · Medtronic Cardiac Rhythm And Heart Failure Crhf - SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
FDA Device · Class II · 2021-12-22 · Cardinal Health - RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
FDA Device · Class II · 2021-12-22 · Cardinal Health - Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-b…
FDA Device · Class II · 2021-12-22 · Activbody - Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU)
FDA Device · Class II · 2021-12-22 · Boston Scientific - smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
FDA Device · Class II · 2021-12-22 · Smith And Nephew - EVLP Convenience Pack/Kit
FDA Device · Class II · 2021-12-22 · Medline Industries - Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
FDA Device · Class II · 2021-12-22 · Cardinal Health - SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
FDA Device · Class II · 2021-12-22 · Cardinal Health - Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
FDA Device · Class II · 2021-12-22 · Ossur Americas - Major Vascular CDS Convenience Kit
FDA Device · Class II · 2021-12-22 · Medline Industries - Bedside PICC CDS Convenience Kit
FDA Device · Class II · 2021-12-22 · Medline Industries - smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
FDA Device · Class II · 2021-12-22 · Smith And Nephew - Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce th…
FDA Device · Class II · 2021-12-22 · Cook - Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
FDA Device · Class II · 2021-12-22 · Medtronic Cardiac Rhythm And Heart Failure Crhf - SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
FDA Device · Class II · 2021-12-22 · Cardinal Health - RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
FDA Device · Class II · 2021-12-22 · Cardinal Health - EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
FDA Device · Class II · 2021-12-22 · Olympus - RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
FDA Device · Class II · 2021-12-22 · Cardinal Health - Venous Access Pack-LF Convenience Kit
FDA Device · Class II · 2021-12-22 · Medline Industries - RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
FDA Device · Class II · 2021-12-22 · Cardinal Health - Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualita…
FDA Device · Class II · 2021-12-22 · Clark Laboratories - Puritan Bennett 980 Series Ventilator, 980A1ENNISB
FDA Device · Class I · 2021-12-15 · Covidien - Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charg…
FDA Device · Class II · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980X1ENNISB
FDA Device · Class I · 2021-12-15 · Covidien - SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM
FDA Device · Class II · 2021-12-15 · Argon Medical Devices - Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
FDA Device · Class I · 2021-12-15 · Covidien - OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01…
FDA Device · Class II · 2021-12-15 · Osteomed - BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system
FDA Device · Class II · 2021-12-15 · Philips North America - O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev…
FDA Device · Class II · 2021-12-15 · Orchestrate Orthodontic Technologies - BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system
FDA Device · Class II · 2021-12-15 · Philips North America - Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980S3ENDICU
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator,980X1ENAIQC
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
FDA Device · Class I · 2021-12-15 · Covidien - Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800
FDA Device · Class II · 2021-12-15 · Northgate Technologies - Puritan Bennett 980 Series Ventilator, 980S1ENDICU
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980A3ENNISB
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
FDA Device · Class I · 2021-12-15 · Covidien - Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Device · Class II · 2021-12-15 · Philips North America - Puritan Bennett 980 Series Ventilator, 980U1ENASAA
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
FDA Device · Class I · 2021-12-15 · Covidien - Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
FDA Device · Class I · 2021-12-15 · Covidien - SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass
FDA Device · Class III · 2021-12-08 · Cardiac Assist - 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
FDA Device · Class II · 2021-12-08 · Howmedica Osteonics - HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
FDA Device · Class II · 2021-12-08 · O And M Halyard - INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
FDA Device · Class II · 2021-12-08 · Wright Medical Technology - Total Thyroxine (T4) ELISA
FDA Device · Class II · 2021-12-08 · Drg International - NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack
FDA Device · Class II · 2021-12-08 · Beeken Biomedical - HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
FDA Device · Class II · 2021-12-08 · Boston Scientific - Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
FDA Device · Class II · 2021-12-08 · Thoratec - HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
FDA Device · Class II · 2021-12-08 · Boston Scientific - HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
FDA Device · Class II · 2021-12-08 · Boston Scientific - HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
FDA Device · Class II · 2021-12-08 · Boston Scientific - Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and…
FDA Device · Class II · 2021-12-08 · Siemens Healthcare Diagnostics - HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
FDA Device · Class II · 2021-12-08 · Boston Scientific - HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
FDA Device · Class II · 2021-12-08 · 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)