FDA Device · 2022
FDA Device recalls in 2022
RecallRadar indexes 2,191 FDA Device recall notices published in 2022. By classification: 168 Class I, 1,946 Class II, 77 Class III.
- SpaceOAR Vue System, UPN SV-1010 and SV-2101
FDA Device · Class II · 2022-05-04 · Boston Scientific - PrisMax System, Product Code 955626
FDA Device · Class II · 2022-05-04 · Baxter Healthcare - NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test S…
FDA Device · Class II · 2022-05-04 · Neumodx Molecular - PrisMax System, Product Code 955724
FDA Device · Class II · 2022-05-04 · Baxter Healthcare - Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only
FDA Device · Class II · 2022-05-04 · Siemens Medical Solutions Usa - Puritan Bennett 980 Series Ventilator
FDA Device · Class I · 2022-05-04 · Medtronic Formerly Covidien - PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
FDA Device · Class II · 2022-05-04 · Baxter Healthcare - da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60…
FDA Device · Class II · 2022-05-04 · Intuitive Surgical - syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660
FDA Device · Class II · 2022-05-04 · Siemens Medical Solutions Usa - ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000
FDA Device · Class II · 2022-05-04 · Carl Zeiss Meditec Ag - syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180
FDA Device · Class II · 2022-05-04 · Siemens Medical Solutions Usa - Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
FDA Device · Class II · 2022-05-04 · Freudenberg Medical - ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished…
FDA Device · Class II · 2022-05-04 · Instrumentation Laboratory - syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670
FDA Device · Class II · 2022-05-04 · Siemens Medical Solutions Usa - Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mot…
FDA Device · Class II · 2022-05-04 · Roi Cps - WAVES WCM Kidney Cassette Module
FDA Device · Class II · 2022-05-04 · Waters Medical Systems - Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Bi…
FDA Device · Class II · 2022-05-04 · Roi Cps - Smart Toe II Intramedullary Arthrodesis Implant
FDA Device · Class II · 2022-05-04 · Stryker - SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101
FDA Device · Class II · 2022-05-04 · Boston Scientific - MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q…
FDA Device · Class II · 2022-05-04 · Medtronic Neuromodulation - Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Device · Class I · 2022-05-04 · Celltrion Usa - syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620
FDA Device · Class II · 2022-05-04 · Siemens Medical Solutions Usa - RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001
FDA Device · Class II · 2022-05-04 · Roche Diabetes Care - IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog num…
FDA Device · Class II · 2022-05-04 · Siemens Healthcare Diagnostics - TearCare version 1.0 SmartHubs
FDA Device · Class II · 2022-05-04 · Sight Sciences - Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12
FDA Device · Class II · 2022-05-04 · Draegar Medical Systems - Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery…
FDA Device · Class II · 2022-05-04 · Roi Cps - HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
FDA Device · Class II · 2022-04-27 · Huntleigh Healthcare - Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control
FDA Device · Class III · 2022-04-27 · Beckman Coulter - Artis Q.zen biplane, Model Number 10848355
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package
FDA Device · Class II · 2022-04-27 · Baxter Healthcare - Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
FDA Device · Class I · 2022-04-27 · Respironics California - Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic…
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Matrix Clinical Solution At-Home COVID-19 Test
FDA Device · Class II · 2022-04-27 · Matrix Medical Network - therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
FDA Device · Class II · 2022-04-27 · Qiagen Sciences - Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
FDA Device · Class II · 2022-04-27 · St Jude Medical Cardiac Rhythm Management Division - ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+…
FDA Device · Class II · 2022-04-27 · Dna Genotek - Artis Q biplane, Model Number 10848282
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Artis Q ceiling, Model Number 10848281
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile
FDA Device · Class II · 2022-04-27 · Abbott - Artis zee biplane MN, Model Number 10094143
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Cardiovascular Procedure Kit catalog # 76645 & 73806
FDA Device · Class II · 2022-04-27 · Terumo Cardiovascular Systems - Artis zee floor MN, Model Number 10094142
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile
FDA Device · Class II · 2022-04-27 · Abbott - Artis Q.zen floor, Model Number 10848353
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Artis zee ceiling, Model Number 10094137
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Artis zee floor, Model Number 10094135
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - 4.0mm x 10mm Cannulated Screw, Short Thread
FDA Device · Class II · 2022-04-27 · Acumed - Artis Q zeego, Model Number 10848283
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Merlin 2 PCS MER3700 programmer Model MER3400 software
FDA Device · Class II · 2022-04-27 · St Jude Medical Cardiac Rhythm Management Division - Artis zee biplane, Model Number 10094141
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
FDA Device · Class II · 2022-04-27 · St Jude Medical Cardiac Rhythm Management Division - Artis Q.zen ceiling, Model Number 10848354
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Artis Q floor, Model Number 10848280
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
FDA Device · Class II · 2022-04-27 · Resource Optimization And Innovation - Artis zeego, Model Number 10280959
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnos…
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Inactivated macrolide-resistant Mycoplasma genitalium
FDA Device · Class II · 2022-04-27 · Microbiologics - therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
FDA Device · Class II · 2022-04-27 · Qiagen Sciences - The Sight OLO device is a computer vision based platform for blood analysis
FDA Device · Class II · 2022-04-27 · Sight Diagnostics - Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
FDA Device · Class I · 2022-04-27 · Respironics California - SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.Al…
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - 4.0mm x 12mm Cannulated Screw, Short Thread
FDA Device · Class II · 2022-04-27 · Acumed - Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001
FDA Device · Class II · 2022-04-27 · Medtronic Xomed - Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
FDA Device · Class II · 2022-04-27 · Acon Biotech Hangzhou - Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717,…
FDA Device · Class I · 2022-04-27 · Respironics California - Artis zee multi-purpose, Model Number 10094139
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
FDA Device · Class II · 2022-04-27 · Microbiologics - Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imag…
FDA Device · Class II · 2022-04-27 · Siemens Medical Solutions Usa - Harmony Delivery Catheter System
FDA Device · Class I · 2022-04-27 · Medtronic - GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery…
FDA Device · Class II · 2022-04-27 · Ge Healthcare - ORAcollect RNA: ORE-100
FDA Device · Class II · 2022-04-27 · Dna Genotek - Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
FDA Device · Class II · 2022-04-27 · St Jude Medical Cardiac Rhythm Management Division - Merlin PCS 3650 programmer Model 3330 software
FDA Device · Class II · 2022-04-27 · St Jude Medical Cardiac Rhythm Management Division - Virus Counter Platform with Model Name VC3100
FDA Device · Class II · 2022-04-27 · Sartorius - 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
FDA Device · Class II · 2022-04-20 · Abbott Vascular - Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
FDA Device · Class II · 2022-04-20 · Medline Industries Northfield - Integra Universal Flexible Arm part number REF 1362275
FDA Device · Class II · 2022-04-20 · Integra Lifesciences - The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A…
FDA Device · Class II · 2022-04-20 · Philips North America - Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
FDA Device · Class II · 2022-04-20 · Siemens Healthcare Diagnostics - Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2…
FDA Device · Class II · 2022-04-20 · Abbott Vascular - Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
FDA Device · Class II · 2022-04-20 · Nextremity Solutions - Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
FDA Device · Class II · 2022-04-20 · Luminex - Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
FDA Device · Class II · 2022-04-20 · Breas Medical - 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
FDA Device · Class II · 2022-04-20 · Abbott Vascular - ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
FDA Device · Class II · 2022-04-20 · Varian Medical Systems Imaging Laboratory - Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
FDA Device · Class II · 2022-04-20 · Nextremity Solutions - CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
FDA Device · Class II · 2022-04-20 · Graphic Controls Acquisition - INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
FDA Device · Class II · 2022-04-20 · Abbott Vascular - CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
FDA Device · Class II · 2022-04-20 · Graphic Controls Acquisition - IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
FDA Device · Class III · 2022-04-20 · Volcano - Separation Technology Creamatocrit Plus, Catalog Number: 100-146
FDA Device · Class II · 2022-04-20 · Stanbio Laboratory - Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems
FDA Device · Class II · 2022-04-20 · B Braun Medical - Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-0…
FDA Device · Class II · 2022-04-20 · Merit Medical Systems - AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-1…
FDA Device · Class II · 2022-04-20 · Merit Medical Systems - Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
FDA Device · Class II · 2022-04-20 · Siemens Healthcare Diagnostics - ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
FDA Device · Class II · 2022-04-20 · Boston Scientific - CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
FDA Device · Class II · 2022-04-20 · Graphic Controls Acquisition - Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
FDA Device · Class II · 2022-04-20 · Medline Industries Northfield - Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
FDA Device · Class II · 2022-04-20 · Nextremity Solutions
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