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.
- FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA Device · Class II · 2024-06-12 · Corentec - ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
FDA Device · Class II · 2024-06-12 · Medline Industries Northfield - ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10
FDA Device · Class II · 2024-06-12 · Medline Industries Northfield - ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX
FDA Device · Class II · 2024-06-12 · Ge Medical Systems Information Technologies - BD SARS-CoV-2 Reagents for BD MAX" Systems
FDA Device · Class II · 2024-06-12 · Becton Dickinson And - ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Leica HistoCore PEGASUS Tissue Processor, REF 14048858005
FDA Device · Class II · 2024-06-12 · Leica Biosystems Nussloch - ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS
FDA Device · Class I · 2024-06-12 · Arrow International - ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description:…
FDA Device · Class II · 2024-06-12 · Verathon - ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - MEGADYNE MEGA SOFT Pediatric Patient Return Electrode
FDA Device · Class I · 2024-06-12 · Megadyne Medical Products - ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
FDA Device · Class II · 2024-06-12 · Corentec - FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
FDA Device · Class II · 2024-06-12 · Ion Beam Applications - ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rat…
FDA Device · Class II · 2024-06-12 · Wavi - ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone
FDA Device · Class II · 2024-06-12 · Newport - BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and…
FDA Device · Class II · 2024-06-12 · Nihon Kohden America - ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
FDA Device · Class II · 2024-06-12 · Verathon - ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
FDA Device · Class II · 2024-06-12 · Remote Diagnostic Technologies - ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly
FDA Device · Class III · 2024-06-12 · Ortho Clinical Diagnostics - ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients
FDA Device · Class II · 2024-06-12 · Medtronic Navigation Littleton - ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e
FDA Device · Class I · 2024-06-12 · Getinge Usa Sales - ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U
FDA Device · Class I · 2024-06-12 · Arrow International - ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 9897100064…
FDA Device · Class II · 2024-06-12 · Philips North America - OES 4000 Hysteroscope, Model/Catalog Number: A4674A
FDA Device · Class II · 2024-06-12 · Olympus - FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Ar…
FDA Device · Class II · 2024-06-12 · Securitas Healthcare - FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 9897100064…
FDA Device · Class II · 2024-06-12 · Philips North America - ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U
FDA Device · Class I · 2024-06-12 · Arrow International - ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
FDA Device · Class II · 2024-06-12 · Medline Industries Northfield - FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 9897100…
FDA Device · Class II · 2024-06-12 · Philips North America - ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
FDA Device · Class II · 2024-06-05 · Carefusion 303 - Captus 4000e Thyroid Uptake System
FDA Device · Class II · 2024-06-05 · Mirion Technologies Capintec - BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
FDA Device · Class II · 2024-06-05 · Carefusion 303 - Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832
FDA Device · Class II · 2024-06-05 · Medline Industries Northfield - Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, t…
FDA Device · Class II · 2024-06-05 · Covidien - Philips Allura Xper FD20 system with an ADN7NT patient table
FDA Device · Class II · 2024-06-05 · Philips Medical Systems Nederland B V
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