FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121,…
FDA Device · Class II · 2023-09-20 · Advance Medical Designs - Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed…
FDA Device · Class I · 2023-09-20 · Abbott Medical - NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots
FDA Device · Class II · 2023-09-20 · Landauer - Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001)
FDA Device · Class II · 2023-09-20 · Landauer - Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device des…
FDA Device · Class I · 2023-09-20 · Abbott Medical - Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003)
FDA Device · Class II · 2023-09-20 · Landauer - QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DNS, Model Numbers: a) 03055-1MO
FDA Device · Class II · 2023-09-20 · Landauer - Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
FDA Device · Class II · 2023-09-20 · Advance Medical Designs - Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
FDA Device · Class II · 2023-09-20 · Philips Medical Systems Nederland B V - nanoDot D2DNS, Model Numbers: a) 18100-000
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000
FDA Device · Class II · 2023-09-20 · Landauer - BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (…
FDA Device · Class II · 2023-09-20 · Ptw Freiburg - remel TODD HEWITT W. CNA (LIM BROTH), REF R064810
FDA Device · Class II · 2023-09-20 · Remel - KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P
FDA Device · Class III · 2023-09-20 · Microbiologics - Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002)
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DNS, Model Numbers: a) 03057-1MO
FDA Device · Class II · 2023-09-20 · Landauer - Reader, nanoDot adapter, EU Model Number VINLADA003
FDA Device · Class II · 2023-09-20 · Landauer - Welch Allyn Connex Spot Monitor
FDA Device · Class II · 2023-09-20 · Baxter Healthcare - nanoDot D2DNN, Model Numbers: a) 03053-1MO
FDA Device · Class II · 2023-09-20 · Landauer - QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002)
FDA Device · Class II · 2023-09-20 · Landauer - QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000
FDA Device · Class II · 2023-09-20 · Landauer - Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO
FDA Device · Class II · 2023-09-20 · Landauer - Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
FDA Device · Class II · 2023-09-20 · Advance Medical Designs - QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000
FDA Device · Class II · 2023-09-20 · Landauer - ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
FDA Device · Class II · 2023-09-20 · Siemens Medical Solutions Usa - Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO
FDA Device · Class II · 2023-09-20 · Landauer - nanoDot D2DXS, Model Numbers: a) 03063-1MO
FDA Device · Class II · 2023-09-20 · Landauer - QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO
FDA Device · Class II · 2023-09-20 · Landauer - Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO
FDA Device · Class II · 2023-09-20 · Landauer - HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
FDA Device · Class I · 2023-09-20 · Medline Industries Northfield - Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 2…
FDA Device · Class II · 2023-09-20 · Advance Medical Designs - FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
FDA Device · Class II · 2023-09-20 · Biofire Diagnostics - NanoDots, Model Number 04297-000
FDA Device · Class II · 2023-09-20 · Landauer - Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile
FDA Device · Class II · 2023-09-20 · Medtronic Sofamor Danek Usa - QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005)
FDA Device · Class II · 2023-09-20 · Landauer - Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device design…
FDA Device · Class I · 2023-09-20 · Abbott Medical - 50-GEL20
FDA Device · Class II · 2023-09-20 · Advance Medical Designs - Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000
FDA Device · Class II · 2023-09-20 · Landauer - ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolys…
FDA Device · Class II · 2023-09-20 · Instrumentation Laboratory - Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-…
FDA Device · Class II · 2023-09-13 · Aomori Olympus - MultiDiagnost-Eleva
FDA Device · Class II · 2023-09-13 · Philips Medical Systems Nederland B V - Azurion
FDA Device · Class II · 2023-09-13 · Philips Medical Systems Nederland B V - Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads
FDA Device · Class II · 2023-09-13 · Cook Vandergrift - Fargo Ortho-K Lens
FDA Device · Class II · 2023-09-13 · Paragon Vision Sciences - ISee Ortho-K Lens
FDA Device · Class II · 2023-09-13 · Paragon Vision Sciences - ZVU Functional GI Software, REF: ZVU-3
FDA Device · Class III · 2023-09-13 · Diversatek Healthcare - Allura Xper series
FDA Device · Class II · 2023-09-13 · Philips Medical Systems Nederland B V - For intraventricular indications mainly used for operations within the brain ventricles
FDA Device · Class II · 2023-09-13 · Aesculap Implant Systems - 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite
FDA Device · Class II · 2023-09-13 · Philips Ultrasound - M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
FDA Device · Class II · 2023-09-13 · Zimmer - Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope
FDA Device · Class II · 2023-09-13 · Aomori Olympus - The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed byp…
FDA Device · Class II · 2023-09-06 · Lemaitre Vascular - epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and record…
FDA Device · Class II · 2023-09-06 · Stryker - Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System
FDA Device · Class II · 2023-09-06 · Accuray - EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
FDA Device · Class II · 2023-09-06 · Olympus - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000
FDA Device · Class II · 2023-09-06 · Cardiac Assist - Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
FDA Device · Class II · 2023-09-06 · Beckman Coulter - Olympus Bronchovideoscope, Models BF-3C160
FDA Device · Class II · 2023-09-06 · Olympus - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class II · 2023-09-06 · Datascope - Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lith…
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - Visera Hysterovideoscope Olympus HYF Type V
FDA Device · Class II · 2023-09-06 · Olympus - Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V
FDA Device · Class II · 2023-09-06 · Olympus - RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and s…
FDA Device · Class II · 2023-09-06 · Raysearch Laboratories Ab - PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
FDA Device · Class II · 2023-09-06 · Edwards Lifesciences - Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160
FDA Device · Class II · 2023-09-06 · Olympus - Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma…
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System
FDA Device · Class II · 2023-09-06 · Alphatec Spine - GS70 Salus Surgical Table, Product Code 18-070-70
FDA Device · Class II · 2023-09-06 · Skytron - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Oculus Myopia Master , Ref 68100, CE 0123
FDA Device · Class II · 2023-09-06 · Oculus Optikgeraete - Olympus Bronchovideoscope, Model BF-Q180-AC
FDA Device · Class II · 2023-09-06 · Olympus - Olympus Airway Mobilescope, Models MAF-GM & MAF-TM
FDA Device · Class II · 2023-09-06 · Olympus - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180
FDA Device · Class II · 2023-09-06 · Olympus - Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithi…
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
FDA Device · Class II · 2023-09-06 · Smiths Medical Asd - Olympus Bronchovideoscope, Models BF-P190 & BF-XP190
FDA Device · Class II · 2023-09-06 · Olympus - Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human se…
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
FDA Device · Class II · 2023-09-06 · Philips Medical Systems Nederland B V - Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP
FDA Device · Class II · 2023-09-06 · Olympus - Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithiu…
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - Oculus Pentacam AXL Wave, Ref 70020, CE 0123
FDA Device · Class II · 2023-09-06 · Oculus Optikgeraete - Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190
FDA Device · Class II · 2023-09-06 · Olympus - Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60
FDA Device · Class II · 2023-09-06 · Olympus - Olympus Bronchovideoscope, Models BF-3C40 & BF-N20
FDA Device · Class II · 2023-09-06 · Olympus - Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2
FDA Device · Class II · 2023-09-06 · Olympus - Oculus Pentacam AXL , Ref 70100, CE 0123
FDA Device · Class II · 2023-09-06 · Oculus Optikgeraete - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class I · 2023-09-06 · Datascope - epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lith…
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium…
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class II · 2023-09-06 · Datascope - epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
FDA Device · Class II · 2023-09-06 · Siemens Healthcare Diagnostics
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