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.

• Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by p…
  FDA Device · Class II · 2021-06-16 · Sunstar Americas
• Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire…
  FDA Device · Class III · 2021-06-16 · Microvention
• COVID-19 Self-Test Kit *** INNOVA *** 7T
  FDA Device · Class I · 2021-06-16 · Innova Medical Group
• Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiat…
  FDA Device · Class II · 2021-06-16 · Viewray
• Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instr…
  FDA Device · Class II · 2021-06-16 · Normand Info S U
• FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
  FDA Device · Class I · 2021-06-16 · Avid Medical
• Ingenia Ambition S - Model Number: 781359 Diagnostic MR system
  FDA Device · Class II · 2021-06-16 · Philips North America
• Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
  FDA Device · Class I · 2021-06-16 · Innova Medical Group
• Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• COVID-19 Self-Test Kit *** INNOVA *** 3T
  FDA Device · Class I · 2021-06-16 · Innova Medical Group
• VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire…
  FDA Device · Class III · 2021-06-16 · Microvention
• Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
  FDA Device · Class II · 2021-06-16 · Philips North America
• Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at…
  FDA Device · Class II · 2021-06-16 · Brainlab Ag
• ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
  FDA Device · Class I · 2021-06-16 · Avid Medical
• Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire…
  FDA Device · Class III · 2021-06-16 · Microvention
• Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013…
  FDA Device · Class II · 2021-06-16 · Nico
• CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131
  FDA Device · Class II · 2021-06-16 · Coopersurgical
• DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
  FDA Device · Class I · 2021-06-16 · Deroyal Industries
• Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and pro…
  FDA Device · Class II · 2021-06-16 · Medtronic Sofamor Danek Usa
• Olympus Sterile Optical Laser Fiber, single use and reusable
  FDA Device · Class II · 2021-06-16 · Quanta System S P A
• Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to…
  FDA Device · Class II · 2021-06-16 · Nico
• Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut
  FDA Device · Class II · 2021-06-16 · Wishbone Medical
• DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis
  FDA Device · Class II · 2021-06-16 · Depuy Orthopaedics
• Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which ca…
  FDA Device · Class II · 2021-06-16 · Medline Industries
• Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392
  FDA Device · Class II · 2021-06-16 · Alphatec Spine
• Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
  FDA Device · Class II · 2021-06-09 · Fujifilm Medical Systems U
• REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery
  FDA Device · Class II · 2021-06-09 · Meta C G M Spa
• ZVplasty Cement Delivery Cannula, REF VCF-1007
  FDA Device · Class II · 2021-06-09 · Zavation
• 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spin…
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11
  FDA Device · Class II · 2021-06-09 · Zavation
• The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temp…
  FDA Device · Class II · 2021-06-09 · Terumo Cardiovascular Systems
• 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11
  FDA Device · Class II · 2021-06-09 · Zavation
• InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11
  FDA Device · Class II · 2021-06-09 · Zavation
• 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Drill, 10 Gauge, REF VCF-1006
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010
  FDA Device · Class II · 2021-06-09 · Zavation
• Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixa…
  FDA Device · Class II · 2021-06-09 · Zimmer
• ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11
  FDA Device · Class II · 2021-06-09 · Zavation
• Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longe…
  FDA Device · Class II · 2021-06-09 · Draeger Medical
• InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10
  FDA Device · Class II · 2021-06-09 · Zavation
• 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11
  FDA Device · Class II · 2021-06-09 · Zavation
• Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or lo…
  FDA Device · Class II · 2021-06-09 · Draeger Medical
• ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• 11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023
  FDA Device · Class II · 2021-06-09 · Zavation
• 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longe…
  FDA Device · Class II · 2021-06-09 · Draeger Medical
• ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the T…
  FDA Device · Class II · 2021-06-09 · Clinical Laserthermia Systems Ab
• 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd
  FDA Device · Class II · 2021-06-09 · Zavation
• Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
  FDA Device · Class II · 2021-06-09 · Elekta
• REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery
  FDA Device · Class II · 2021-06-09 · Meta C G M Spa
• MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.…
  FDA Device · Class II · 2021-06-09 · Medtronic Minimed
• Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated…
  FDA Device · Class II · 2021-06-09 · K2m
• 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation
• Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer
  FDA Device · Class II · 2021-06-09 · Clinical Laserthermia Systems Ab
• Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris…
  FDA Device · Class I · 2021-06-09 · The Biomed Guys
• 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures
  FDA Device · Class II · 2021-06-09 · Zavation

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)