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.
- Model A710 Intellis Clinician Programmer Application, version 2.0.97
FDA Device · Class II · 2024-01-31 · Medtronic Neuromodulation - REV 2 Flowcell Capsule Spare, Part Number: C04154
FDA Device · Class II · 2024-01-31 · Beckman Coulter - Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
FDA Device · Class II · 2024-01-31 · C R Bard - Achieva 1.5T Conversion, Model No. 781283
FDA Device · Class III · 2024-01-31 · Philips North America - TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile
FDA Device · Class II · 2024-01-31 · St Jude Medical Atrial Fibrillation Division - Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
FDA Device · Class II · 2024-01-31 · C R Bard - Sedecal X Optima URS digital mobile diagnostic x-ray system
FDA Device · Class II · 2024-01-31 · Sedecal - Achieva 1.5T, Model No. 781178, 781196, 781296
FDA Device · Class III · 2024-01-31 · Philips North America - Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
FDA Device · Class II · 2024-01-31 · C R Bard - Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
FDA Device · Class II · 2024-01-31 · C R Bard - Achieva 3.0T, Model No. 781177
FDA Device · Class III · 2024-01-31 · Philips North America - Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
FDA Device · Class II · 2024-01-31 · C R Bard - Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
FDA Device · Class II · 2024-01-31 · Beckman Coulter - Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
FDA Device · Class II · 2024-01-31 · C R Bard - Accure Laser System, Model: PFMS00004
FDA Device · Class II · 2024-01-31 · Accure Acne - bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66
FDA Device · Class II · 2024-01-31 · B K Medical A S - Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
FDA Device · Class II · 2024-01-31 · C R Bard - Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
FDA Device · Class II · 2024-01-31 · Medtronic - EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000
FDA Device · Class II · 2024-01-31 · Phadia Ab - Snapshot NIR, REF: KD204
FDA Device · Class II · 2024-01-31 · Kent Imaging - Incisive CT, Model Numbers 728144 and 728143
FDA Device · Class II · 2024-01-24 · Philips North America - Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
FDA Device · Class II · 2024-01-24 · Olympus - Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
FDA Device · Class I · 2024-01-24 · Percussionaire - Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged
FDA Device · Class II · 2024-01-24 · Greiner Bio One North America - 6IN PRESSURE TUBING, List Number MX20617
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDP…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - Medex LOGICAL CATH LAB KIT, List Number M20754
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
FDA Device · Class II · 2024-01-24 · Olympus - regard Operative LAP, Item Number 800943001
FDA Device · Class I · 2024-01-24 · Roi Cps - Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500
FDA Device · Class II · 2024-01-24 · Maquet Cardiovascular - 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
FDA Device · Class II · 2024-01-24 · Randox Laboratories - Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF ST…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C,…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W
FDA Device · Class II · 2024-01-24 · Maquet Cardiovascular - PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
FDA Device · Class II · 2024-01-24 · Becton Dickinson And - V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tap…
FDA Device · Class II · 2024-01-24 · Steris - TECNIS Toric II OptiBlue IOL Models ZCW
FDA Device · Class II · 2024-01-24 · Johnson And Johnson Surgical Vision - 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - Curaplex Field Cric Kit with ET Tube, Item Number 36611
FDA Device · Class II · 2024-01-24 · Sarnova Hc - Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
FDA Device · Class II · 2024-01-24 · Cardinal Health 200 - CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
FDA Device · Class II · 2024-01-24 · Cardinal Health 200 - Ultrasound EA (Ergonomic Advantage) table version
FDA Device · Class II · 2024-01-24 · Oakworks - Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
FDA Device · Class II · 2024-01-24 · Phase Scientific International - Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, O…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
FDA Device · Class II · 2024-01-24 · Philips North America - Ultrasound EA (Ergonomic Advantage) table versions
FDA Device · Class II · 2024-01-24 · Oakworks - Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD5677…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - Ultrasound EA (Ergonomic Advantage) table versions
FDA Device · Class II · 2024-01-24 · Oakworks - Calibration Serum Level 3 CAL2351
FDA Device · Class II · 2024-01-24 · Randox Laboratories - PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
FDA Device · Class II · 2024-01-24 · Limacorporate S P A - Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 -…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System
FDA Device · Class II · 2024-01-24 · Xcision Medical Systems - Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals…
FDA Device · Class II · 2024-01-24 · Sarnova Hc - SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
FDA Device · Class II · 2024-01-24 · Olympus - Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
FDA Device · Class I · 2024-01-24 · Maquet Cardiovascular - Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System
FDA Device · Class II · 2024-01-24 · Philips North America - Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD56822…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD5681…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
FDA Device · Class I · 2024-01-24 · Globus Medical - Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model N…
FDA Device · Class II · 2024-01-24 · Philips North America - Ultrasound EA (Ergonomic Advantage) table versions
FDA Device · Class II · 2024-01-24 · Oakworks - MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
FDA Device · Class II · 2024-01-24 · Cook Medical - Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C,…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
FDA Device · Class II · 2024-01-24 · Abbott Diabetes Care - Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure
FDA Device · Class II · 2024-01-24 · Waldemar Link And Kg Mfg Site - Calibration Serum Level 3. CAL 3, REF CAL2351
FDA Device · Class II · 2024-01-24 · Randox Laboratories - High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
FDA Device · Class I · 2024-01-24 · Percussionaire - Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
FDA Device · Class I · 2024-01-24 · Maquet Cardiovascular - Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 -…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAI…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
FDA Device · Class II · 2024-01-24 · Cardinal Health 200 - HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50…
FDA Device · Class II · 2024-01-24 · Getinge Usa Sales - SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
FDA Device · Class II · 2024-01-24 · Olympus - 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
FDA Device · Class II · 2024-01-24 · Smiths Medical Asd - Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introducti…
FDA Device · Class II · 2024-01-17 · Abiomed - Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Model No. BF-P190, EVIS EXERA III Bronchovideoscope
FDA Device · Class II · 2024-01-17 · Shirakawa Olympus - BrightView XCT, Gamma Camera, Product Code 882482
FDA Device · Class II · 2024-01-17 · Philips North America - SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System
FDA Device · Class II · 2024-01-17 · Soclean - Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Detector H. Pylori, Catalog Number IHP-30
FDA Device · Class II · 2024-01-17 · Immunostics - Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and cont…
FDA Device · Class II · 2024-01-17 · Abbott Laboratories - ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designe…
FDA Device · Class II · 2024-01-17 · Abbott Laboratories - Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation - BrightView, Gamma Camera System, Product Code 882480
FDA Device · Class II · 2024-01-17 · Philips North America - Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation - Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use wit…
FDA Device · Class II · 2024-01-17 · Biofire Diagnostics - Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070
FDA Device · Class II · 2024-01-17 · Baxter Healthcare - Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM
FDA Device · Class II · 2024-01-17 · Bard Peripheral Vascular - CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
FDA Device · Class II · 2024-01-17 · Blue Belt Technologies
Other years
2026 (2,088) · 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)