FDA Device · 2024
FDA Device recalls in 2024
RecallRadar indexes 3,393 FDA Device recall notices published in 2024. By classification: 392 Class I, 2,970 Class II, 31 Class III.
- MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
FDA Device · Class II · 2024-01-17 · Cordis Us - XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-03…
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or B…
FDA Device · Class II · 2024-01-17 · Biofire Diagnostics - OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentatio…
FDA Device · Class II · 2024-01-17 · Olympus - Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile
FDA Device · Class II · 2024-01-17 · Medline Industries Northfield - BrightView X, Gamma Camera, Product Code 882478
FDA Device · Class II · 2024-01-17 · Philips North America - Model No. CYF-5R, Cystonephrofiberscope
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used…
FDA Device · Class II · 2024-01-17 · Boston Scientific - Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Sensis Vibe Hemo
FDA Device · Class II · 2024-01-17 · Siemens Medical Solutions Usa - OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentatio…
FDA Device · Class II · 2024-01-17 · Olympus - Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation eq…
FDA Device · Class II · 2024-01-17 · Olympus - SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V…
FDA Device · Class II · 2024-01-17 · Townsend Design - Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter i…
FDA Device · Class II · 2024-01-17 · Abiomed - Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM…
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and contin…
FDA Device · Class II · 2024-01-17 · Abbott Laboratories - Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8…
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Scoot Control R-net, Product Number P015-61
FDA Device · Class II · 2024-01-17 · Mo Vis Bvba - Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter…
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into…
FDA Device · Class II · 2024-01-17 · Abiomed - Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into…
FDA Device · Class II · 2024-01-17 · Abiomed - Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Device · Class II · 2024-01-17 · Townsend Design - CD11b APC: ASR, REF: 340936, and CE, REF: 333143
FDA Device · Class II · 2024-01-17 · Becton Dickinson And Bd Biosciences - Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
FDA Device · Class II · 2024-01-17 · Cordis Us - SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
FDA Device · Class II · 2024-01-17 · Soclean - Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body
FDA Device · Class II · 2024-01-17 · Abiomed - SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Device · Class II · 2024-01-17 · Townsend Design - Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM…
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter i…
FDA Device · Class II · 2024-01-17 · Abiomed - VADER pedicle system, torque wrench, Catalog Number 42-703
FDA Device · Class II · 2024-01-17 · Icotec Ag - Incisive CT, model 728143 & 728144 running Software Version 5.0.0
FDA Device · Class II · 2024-01-17 · Philips Healthcare Suzhou - Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the…
FDA Device · Class II · 2024-01-17 · Abiomed - VADER pedicle system, torque wrench, Catalog Number 42-702
FDA Device · Class II · 2024-01-17 · Icotec Ag - QMS Tacrolimus Calibrators, Product code 10015573
FDA Device · Class II · 2024-01-17 · Ortho Clinical Diagnostics - NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID
FDA Device · Class II · 2024-01-17 · Medtronic Xomed - Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body
FDA Device · Class II · 2024-01-17 · Abiomed - Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021
FDA Device · Class II · 2024-01-17 · Abiomed - Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS,…
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - (1) Ingenia Ambition X (Product Number 781356)
FDA Device · Class II · 2024-01-17 · Philips North America - Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL…
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
FDA Device · Class II · 2024-01-17 · Ambu - BD Recanalization System, REF: BDRECANSYSTEM
FDA Device · Class II · 2024-01-17 · Bard Peripheral Vascular - Model No. CYF-5, Cystonephrofiberscope
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2…
FDA Device · Class II · 2024-01-10 · Philips Respironics - Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
FDA Device · Class I · 2024-01-10 · Busse Hospital Disposables - Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
FDA Device · Class II · 2024-01-10 · Merit Medical Systems - Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
FDA Device · Class II · 2024-01-10 · Covidien - Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
FDA Device · Class II · 2024-01-10 · Beaver Visitec International - KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, reposi…
FDA Device · Class II · 2024-01-10 · Keystone Industries - Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
FDA Device · Class I · 2024-01-10 · Busse Hospital Disposables - Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
FDA Device · Class I · 2024-01-10 · Busse Hospital Disposables - Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B,…
FDA Device · Class II · 2024-01-10 · Merit Medical Systems - Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
FDA Device · Class II · 2024-01-10 · Merit Medical Systems - SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV…
FDA Device · Class III · 2024-01-10 · Randox Laboratories - Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current)
FDA Device · Class I · 2024-01-10 · Insulet - Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data
FDA Device · Class II · 2024-01-10 · Abiomed - Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
FDA Device · Class II · 2024-01-10 · Beaver Visitec International - REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
FDA Device · Class II · 2024-01-10 · Encore Medical - Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
FDA Device · Class II · 2024-01-10 · Zimmer Biomet Spine - External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
FDA Device · Class II · 2024-01-10 · Natus Medical - Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
FDA Device · Class II · 2024-01-10 · Encore Medical - EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
FDA Device · Class II · 2024-01-10 · Natus Medical - Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile
FDA Device · Class II · 2024-01-10 · Medtronic - Regard Dressing change kit, Item Number 800026006
FDA Device · Class I · 2024-01-10 · Roi Cps - Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile
FDA Device · Class I · 2024-01-03 · Medline Industries Northfield - RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a…
FDA Device · Class II · 2024-01-03 · Acumed - Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
FDA Device · Class III · 2024-01-03 · Fresenius Medical Care Holdings - Alinity ci-series System Control Module, REF: 03R70-01
FDA Device · Class II · 2024-01-03 · Abbott Laboratories - Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
FDA Device · Class II · 2024-01-03 · Landauer - Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…
FDA Device · Class II · 2024-01-03 · Arjohuntleigh Polska Sp Z O O - DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
FDA Device · Class II · 2024-01-03 · Deroyal Industries - Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual…
FDA Device · Class I · 2024-01-03 · Megadyne Medical Products - Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…
FDA Device · Class II · 2024-01-03 · Arjohuntleigh Polska Sp Z O O - Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
FDA Device · Class I · 2024-01-03 · Megadyne Medical Products - (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use
FDA Device · Class I · 2024-01-03 · Medline Industries Northfield - (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use
FDA Device · Class I · 2024-01-03 · Medline Industries Northfield - Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Descript…
FDA Device · Class II · 2024-01-03 · Steris - Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
FDA Device · Class I · 2024-01-03 · Megadyne Medical Products - Atrium Oasis Drain Single W / AC, Part No. 3600-100
FDA Device · Class II · 2024-01-03 · Atrium Medical - Medtronic SynchroMed II, Model 8637-40, Programmable pump
FDA Device · Class II · 2024-01-03 · Medtronic Neuromodulation - Medtronic SynchroMed II, Model 8637-20, Programmable pump
FDA Device · Class II · 2024-01-03 · Medtronic Neuromodulation - Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal…
FDA Device · Class I · 2024-01-03 · Megadyne Medical Products
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