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.
- CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
FDA Device · Class II · 2022-04-20 · Graphic Controls Acquisition - LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447…
FDA Device · Class II · 2022-04-20 · Kaneka America - ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
FDA Device · Class II · 2022-04-20 · Boston Scientific - Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #1196…
FDA Device · Class II · 2022-04-20 · Deerfield Imaging - 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL212…
FDA Device · Class II · 2022-04-20 · Abbott Vascular - Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
FDA Device · Class II · 2022-04-20 · Siemens Healthcare Diagnostics - Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
FDA Device · Class II · 2022-04-20 · Nextremity Solutions - MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
FDA Device · Class II · 2022-04-20 · Ge Healthcare - MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integr…
FDA Device · Class III · 2022-04-20 · Volcano - Cub 2 Enclosed Bed Canopy System
FDA Device · Class I · 2022-04-20 · Sensory Medical - Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
FDA Device · Class II · 2022-04-20 · Siemens Healthcare Diagnostics - Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems
FDA Device · Class II · 2022-04-20 · B Braun Medical - Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
FDA Device · Class II · 2022-04-20 · Cardinal Health 200 - CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
FDA Device · Class II · 2022-04-20 · Graphic Controls Acquisition - iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
FDA Device · Class II · 2022-04-20 · Conformis - Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog…
FDA Device · Class II · 2022-04-20 · Medline Industries Northfield - Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
FDA Device · Class II · 2022-04-20 · Nextremity Solutions - CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
FDA Device · Class II · 2022-04-20 · Graphic Controls Acquisition - Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Numb…
FDA Device · Class II · 2022-04-13 · Draeger Medical - Alinity m HBV AMP Kit (US and CE)
FDA Device · Class II · 2022-04-13 · Abbott Molecular - C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine
FDA Device · Class II · 2022-04-13 · Drg International - 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
FDA Device · Class II · 2022-04-13 · Ge Healthcare - Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917
FDA Device · Class III · 2022-04-13 · Cook Medical - ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem…
FDA Device · Class II · 2022-04-13 · Abbott Laboratories - Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
FDA Device · Class II · 2022-04-13 · Remote Diagnostic Technologies - MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems - Lum Lam Custom Pack - Anesthesia Kit
FDA Device · Class II · 2022-04-13 · Stradis Medical - MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems - Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001
FDA Device · Class II · 2022-04-13 · Maquet Cardiovascular - Philips, REF M5071A, Adult
FDA Device · Class II · 2022-04-13 · Philips North America - Revolution Apex, Revolution CT with Apex Edition
FDA Device · Class II · 2022-04-13 · Ge Healthcare - Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
FDA Device · Class II · 2022-04-13 · Philips Healthcare - Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices)
FDA Device · Class II · 2022-04-13 · Brius Technologies - 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile
FDA Device · Class II · 2022-04-13 · Ge Healthcare - Amplatzer Steerable Delivery Sheath
FDA Device · Class II · 2022-04-13 · Abbott - DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the pat…
FDA Device · Class II · 2022-04-13 · Deroyal Industries - Customized Brius Appliances (custom metal orthodontic devices)
FDA Device · Class II · 2022-04-13 · Brius Technologies - Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus
FDA Device · Class II · 2022-04-13 · Hologic - Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 72…
FDA Device · Class II · 2022-04-13 · Philips North America - Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
FDA Device · Class II · 2022-04-13 · Brius Technologies - BenchMark ULTRA and DISCOVERY ULTRA Instruments
FDA Device · Class II · 2022-04-13 · Ventana Medical Systems - Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502
FDA Device · Class III · 2022-04-13 · Cook Medical - Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood…
FDA Device · Class II · 2022-04-13 · Maquet Medical Systems Usa - Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
FDA Device · Class II · 2022-04-13 · Siemens Medical Solutions Usa - First SIGN SARS-CoV-2 Antigen Test
FDA Device · Class II · 2022-04-13 · Whpm - Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Device · Class II · 2022-04-13 · Sa3 - SIGNA Excite 3T. Magnetic Resonance Imaging System
FDA Device · Class II · 2022-04-13 · Ge Healthcare - Anterior Hip Pack - Surgical Kit
FDA Device · Class II · 2022-04-13 · Stradis Medical - MODEL: X-RAY TV SYSTEM SONIALVISION G4
FDA Device · Class II · 2022-04-13 · Shimadzu Medical Systems - SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
FDA Device · Class II · 2022-04-13 · Volcano - Alinity m HBV Application Specification File (US and CE)
FDA Device · Class II · 2022-04-13 · Abbott Molecular - Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg…
FDA Device · Class II · 2022-04-13 · Draeger Medical - Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
FDA Device · Class II · 2022-04-13 · Stradis Medical - Total Knee Pack - Surgical Kit
FDA Device · Class II · 2022-04-13 · Stradis Medical - DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for prepara…
FDA Device · Class II · 2022-04-13 · Deroyal Industries - Surgicare Neuro Pack - Neurological Kit
FDA Device · Class II · 2022-04-13 · Stradis Medical - Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERIL…
FDA Device · Class II · 2022-04-13 · Philips North America - Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Content…
FDA Device · Class II · 2022-04-13 · Medline Industries Northfield - YSIO X.Pree
FDA Device · Class II · 2022-04-13 · Siemens Medical Solutions Usa - DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation o…
FDA Device · Class II · 2022-04-13 · Deroyal Industries - Revolution CT, Revolution CT ES
FDA Device · Class II · 2022-04-13 · Ge Healthcare - Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
FDA Device · Class II · 2022-04-13 · Ge Healthcare - RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35)…
FDA Device · Class II · 2022-04-06 · Raysearch America - Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System
FDA Device · Class II · 2022-04-06 · Siemens Healthcare Diagnostics - Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
FDA Device · Class II · 2022-04-06 · Illumina - Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories
FDA Device · Class II · 2022-04-06 · Meridian Bioscience - Regard Custom Procedure Kits containing BD Luer Lok Access Devices
FDA Device · Class III · 2022-04-06 · Roi Cps - FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA
FDA Device · Class II · 2022-04-06 · Edwards Lifesciences - EasyFuse Dynamic Compression System Instrument Pack
FDA Device · Class II · 2022-04-06 · Wright Medical Technology - FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
FDA Device · Class II · 2022-04-06 · Edwards Lifesciences - MiniMed 630G: MMT-1715, MMT-1754, MMT-1755
FDA Device · Class II · 2022-04-06 · Medtronic Minimed - Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032
FDA Device · Class II · 2022-04-06 · Howmedica Osteonics - Hanger-Bar 2P 45cm
FDA Device · Class II · 2022-04-06 · Human Care Usa - Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
FDA Device · Class II · 2022-04-06 · Ansell Healthcare Products - Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Posit…
FDA Device · Class II · 2022-04-06 · Microbiologics - TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19,…
FDA Device · Class II · 2022-04-06 · Raysearch Laboratories Ab - Ysiosystem with VC10 software version, Model Number 10281013
FDA Device · Class II · 2022-04-06 · Siemens Medical Solutions Usa - (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910
FDA Device · Class II · 2022-04-06 · Carefusion 2200 - Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087
FDA Device · Class II · 2022-04-06 · Baxter Healthcare - CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
FDA Device · Class II · 2022-04-06 · Diagnos - Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
FDA Device · Class II · 2022-04-06 · Howmedica Osteonics - cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
FDA Device · Class II · 2022-04-06 · Roche Molecular Systems - BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French
FDA Device · Class II · 2022-04-06 · Avanos Medical - Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT…
FDA Device · Class II · 2022-04-06 · Infutronix - MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
FDA Device · Class II · 2022-04-06 · Baxter Healthcare - BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter
FDA Device · Class II · 2022-04-06 · Avanos Medical - BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French
FDA Device · Class II · 2022-04-06 · Avanos Medical - RayStation/RayPlan versions 4 - 11A, including service packs
FDA Device · Class II · 2022-04-06 · Raysearch Laboratories Ab - Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
FDA Device · Class II · 2022-04-06 · Mevion Medical Systems - Hanger-Bar 2P 45cm
FDA Device · Class II · 2022-04-06 · Human Care Usa - Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/o…
FDA Device · Class II · 2022-03-30 · Integra Lifesciences - Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
FDA Device · Class II · 2022-03-30 · Outset Medical - BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160…
FDA Device · Class II · 2022-03-30 · Biomet - PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Nu…
FDA Device · Class II · 2022-03-30 · B Braun Medical - Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospit…
FDA Device · Class I · 2022-03-30 · Philips Respironics - Compella Bariatric Bed System
FDA Device · Class II · 2022-03-30 · Baxter Healthcare - Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
FDA Device · Class III · 2022-03-30 · Cytocell - DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C…
FDA Device · Class II · 2022-03-30 · Dignitana - BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item…
FDA Device · Class II · 2022-03-30 · Biomet - BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275…
FDA Device · Class II · 2022-03-30 · Biomet
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