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.
- Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
FDA Device · Class II · 2023-08-16 · Philips North America - CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
FDA Device · Class II · 2023-08-16 · Medtronic Sofamor Danek Usa - Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
FDA Device · Class II · 2023-08-16 · Philips North America - HoverMatt, 39" W x 78" L, REF: HM39SPU-B
FDA Device · Class II · 2023-08-16 · Stryker Sustainability Solutions - ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures
FDA Device · Class II · 2023-08-16 · Siemens Medical Solutions Usa - Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
FDA Device · Class II · 2023-08-16 · Philips North America - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
FDA Device · Class II · 2023-08-16 · Philips North America - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - Total Hip Kit, REF DYNJ903275S
FDA Device · Class II · 2023-08-16 · Medline Industries Northfield - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
FDA Device · Class II · 2023-08-16 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Troponin I ES Calibrators
FDA Device · Class II · 2023-08-16 · Ortho Clinical Diagnostics - Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other an…
FDA Device · Class II · 2023-08-16 · Olympus - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures
FDA Device · Class II · 2023-08-16 · Siemens Medical Solutions Usa - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and the…
FDA Device · Class II · 2023-08-16 · Olympus - Randox RX Series Urea Enzymatic Kinetic Assay Ref
FDA Device · Class II · 2023-08-16 · Randox Laboratories - LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects…
FDA Device · Class II · 2023-08-16 · Waldemar Link And Kg Mfg Site - MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
FDA Device · Class II · 2023-08-16 · Philips North America - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
FDA Device · Class II · 2023-08-09 · Philips North America - ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery
FDA Device · Class II · 2023-08-09 · Maquet Cardiovascular - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
FDA Device · Class II · 2023-08-09 · Creganna Medical Devices - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed…
FDA Device · Class II · 2023-08-09 · Shimadzu Medical Systems Division - TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
FDA Device · Class II · 2023-08-09 · Johnson And Johnson Surgical Vision - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interve…
FDA Device · Class II · 2023-08-09 · Olympus - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interv…
FDA Device · Class II · 2023-08-09 · Olympus - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278
FDA Device · Class II · 2023-08-09 · Wilson Cook Medical - Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for…
FDA Device · Class II · 2023-08-09 · Olympus - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suctio…
FDA Device · Class II · 2023-08-09 · Megadyne Medical Products - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and f…
FDA Device · Class II · 2023-08-09 · Olympus - Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number…
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions…
FDA Device · Class II · 2023-08-09 · Olympus - Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, st…
FDA Device · Class II · 2023-08-09 · Microtek Medical - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277
FDA Device · Class II · 2023-08-09 · Wilson Cook Medical - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Mode…
FDA Device · Class II · 2023-08-09 · Microtek Medical - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for ana…
FDA Device · Class II · 2023-08-09 · Olympus - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery
FDA Device · Class II · 2023-08-09 · Maquet Cardiovascular - Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
FDA Device · Class II · 2023-08-09 · Philips North America - VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
FDA Device · Class II · 2023-08-09 · Johnson And Johnson Surgical Vision - Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventio…
FDA Device · Class II · 2023-08-09 · Olympus - Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
FDA Device · Class II · 2023-08-09 · Philips North America - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Sy…
FDA Device · Class II · 2023-08-09 · Siemens Medical Solutions Usa - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Azurion 7 M20
FDA Device · Class II · 2023-08-09 · Philips Medical Systems Nederland B V - Covidien Cytosponge Cell Collection Device, REF: CYTO-201
FDA Device · Class II · 2023-08-09 · Covidien - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides
FDA Device · Class II · 2023-08-09 · Hamamatsu - ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000
FDA Device · Class II · 2023-08-09 · Maquet Cardiovascular - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - OEC 9900 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
FDA Device · Class II · 2023-08-09 · Johnson And Johnson Surgical Vision - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecul…
FDA Device · Class II · 2023-08-09 · Neumodx Molecular - ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000
FDA Device · Class II · 2023-08-09 · Maquet Cardiovascular - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
FDA Device · Class I · 2023-08-09 · Abiomed - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - OEC Elite Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems - Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
FDA Device · Class II · 2023-08-09 · Medline Industries Northfield - STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means…
FDA Device · Class II · 2023-08-09 · Scican
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)