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.
- 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Device · Class II · 2024-06-05 · Alcon Research - Philips Allura Xper FD20 Biplane system with an ADN7NT patient table
FDA Device · Class II · 2024-06-05 · Philips Medical Systems Nederland B V - Trevo Trak 21 Microcatheter, Catalog: 90338
FDA Device · Class II · 2024-06-05 · Stryker Neurovascular - Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1…
FDA Device · Class II · 2024-06-05 · Stryker Orthopaedics - ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knif…
FDA Device · Class II · 2024-06-05 · Alcon Research - FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremi…
FDA Device · Class II · 2024-06-05 · Fujifilm Healthcare Americas - Captus 4000e Thyroid Uptake System with Well and 2 inch shielding
FDA Device · Class II · 2024-06-05 · Mirion Technologies Capintec - RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionali…
FDA Device · Class II · 2024-06-05 · Reflexion Medical - Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT ST…
FDA Device · Class II · 2024-06-05 · Stryker Neurovascular - Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1…
FDA Device · Class II · 2024-06-05 · Stryker Orthopaedics - BD Pyxis MedStation ES, REF: 323, Medication Cabinet
FDA Device · Class II · 2024-06-05 · Carefusion 303 - Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1…
FDA Device · Class II · 2024-06-05 · Stryker Orthopaedics - Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1…
FDA Device · Class II · 2024-06-05 · Stryker Orthopaedics - Centurion OB INSTRUMENT TRAY, REF MN3925
FDA Device · Class II · 2024-06-05 · Medline Industries Northfield - DAC 044 115cm, Catalog: 90760
FDA Device · Class II · 2024-06-05 · Stryker Neurovascular - Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Cata…
FDA Device · Class II · 2024-06-05 · Stryker Neurovascular - ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Kn…
FDA Device · Class II · 2024-06-05 · Alcon Research - Trevo Pro 14 Microcatheter, Catalog: 90231
FDA Device · Class II · 2024-06-05 · Stryker Neurovascular - Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID
FDA Device · Class I · 2024-06-05 · Medline Industries Northfield - Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascula…
FDA Device · Class II · 2024-06-05 · Philips Medical Systems Nederland B V - FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
FDA Device · Class II · 2024-06-05 · Stryker Neurovascular - BD Pyxis(TM) Anesthesia Station 4000, REF: 338
FDA Device · Class II · 2024-06-05 · Carefusion 303 - ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Kn…
FDA Device · Class II · 2024-06-05 · Alcon Research - STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic sur…
FDA Device · Class II · 2024-06-05 · Synthes Usa Products - Trevo ProVue, Catalog: 90184
FDA Device · Class II · 2024-06-05 · Stryker Neurovascular - Philips Allura Xper FD10 system with an ADN7NT patient table
FDA Device · Class II · 2024-06-05 · Philips Medical Systems Nederland B V - Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
FDA Device · Class II · 2024-06-05 · Boston Scientific Neuromodulation - Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog…
FDA Device · Class II · 2024-06-05 · Stryker Neurovascular - Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1…
FDA Device · Class II · 2024-06-05 · Stryker Orthopaedics - Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, C…
FDA Device · Class II · 2024-06-05 · Agilent Technologies - BD Pyxis" Anesthesia Station ES, REF: 327
FDA Device · Class II · 2024-06-05 · Carefusion 303 - Captus 4000e Thyroid Uptake System with Well
FDA Device · Class II · 2024-06-05 · Mirion Technologies Capintec - smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile
FDA Device · Class II · 2024-06-05 · Smith And Nephew - Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1…
FDA Device · Class II · 2024-06-05 · Stryker Orthopaedics - Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product…
FDA Device · Class II · 2024-06-05 · Lucid Diagnostics - Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product…
FDA Device · Class II · 2024-06-05 · Lucid Diagnostics - BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
FDA Device · Class II · 2024-06-05 · Carefusion 303 - Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Numbe…
FDA Device · Class II · 2024-05-29 · Philips North America - SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devi…
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - SmartPath to dStream for 3.0T Model Number (REF): 782145
FDA Device · Class II · 2024-05-29 · Philips North America - AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 7812…
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes without needles for si…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles fo…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - BiPAP V30 Auto Ventilator, Part Number 1111178
FDA Device · Class I · 2024-05-29 · Philips Respironics - Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Descriptio…
FDA Device · Class II · 2024-05-29 · Channel Medsystems - Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (…
FDA Device · Class II · 2024-05-29 · Philips North America - Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes without needles for si…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Sterile syringes without n…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Sterile syringes without n…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles for si…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON-Sterile syringes with…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody
FDA Device · Class II · 2024-05-29 · Siemens Healthcare Diagnostics - Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile syringes without needl…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for si…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Stryker Blueprint Software, Catalog #BPUE001
FDA Device · Class II · 2024-05-29 · Tornier S - Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles f…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
FDA Device · Class II · 2024-05-29 · Merit Medical Systems - Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles f…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syringes without needles f…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without n…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile syringes without needl…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needle…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syringes without needles fo…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Ingenia 1.5T Model Number (REF): (1) 782140
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for sin…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series
FDA Device · Class II · 2024-05-29 · Yamaha Motor - Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Descripti…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16
FDA Device · Class II · 2024-05-29 · Stryker Leibinger And Kg - Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes without needles for sing…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syringes without needles f…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - InstaClear Lens Sheath
FDA Device · Class II · 2024-05-29 · Olympus - 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
FDA Device · Class II · 2024-05-29 · Fresenius Medical Care Holdings - Achieva 1.5T Initial system Model Number (REF): 781178
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Sterile syringes without nee…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Ingenia Ambition S Model Number (REF): (1) 782139
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product Description: NON-Sterile syringes without needles f…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Sterile syringes without ne…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body
FDA Device · Class II · 2024-05-29 · Philips North America - Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syring…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Sterile syringes without…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Descripti…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without need…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production - Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
FDA Device · Class II · 2024-05-29 · Philips North America - Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles fo…
FDA Device · Class II · 2024-05-29 · Jiangsu Shenli Medical Production
Other years
2026 (2,024) · 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)