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.
- DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
FDA Device · Class II · 2023-05-10 · Dermlite - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
FDA Device · Class II · 2023-05-10 · Linkbio - Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908…
FDA Device · Class II · 2023-05-10 · Ge Healthcare - VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analyte…
FDA Device · Class II · 2023-05-10 · Ortho Clinical Diagnostics - LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
FDA Device · Class II · 2023-05-10 · Linkbio - Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 2164940…
FDA Device · Class II · 2023-05-10 · Baxter Healthcare - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
FDA Device · Class II · 2023-05-10 · Linkbio - VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a var…
FDA Device · Class II · 2023-05-10 · Ortho Clinical Diagnostics - LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12
FDA Device · Class II · 2023-05-10 · Linkbio - DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
FDA Device · Class II · 2023-05-10 · Devilbiss Healthcare - LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
FDA Device · Class II · 2023-05-10 · Linkbio - LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
FDA Device · Class II · 2023-05-10 · Linkbio - FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
FDA Device · Class II · 2023-05-03 · Richard Wolf - FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
FDA Device · Class II · 2023-05-03 · Richard Wolf - stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
FDA Device · Class II · 2023-05-03 · Wright Medical Technology - VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
FDA Device · Class II · 2023-05-03 · Covidien - Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack
FDA Device · Class II · 2023-05-03 · Roi Cps - MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
FDA Device · Class II · 2023-05-03 · Datascope - Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only
FDA Device · Class II · 2023-05-03 · Aesculap Implant Systems - FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
FDA Device · Class II · 2023-05-03 · Richard Wolf - ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures
FDA Device · Class II · 2023-05-03 · Siemens Medical Solutions Usa - (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm)
FDA Device · Class II · 2023-05-03 · Carefusion 2200 - Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the…
FDA Device · Class II · 2023-05-03 · Mani Kiyohara Facility - FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
FDA Device · Class II · 2023-05-03 · Richard Wolf - Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip
FDA Device · Class II · 2023-05-03 · Roi Cps - Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatri…
FDA Device · Class II · 2023-05-03 · Draeger Medical Systems - Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack
FDA Device · Class II · 2023-05-03 · Roi Cps - GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012
FDA Device · Class II · 2023-05-03 · Baxter Healthcare - Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk
FDA Device · Class II · 2023-05-03 · Roi Cps - HAMILTON-C6, REF: 160021
FDA Device · Class II · 2023-05-03 · Hamilton Medical Ag - Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical…
FDA Device · Class II · 2023-05-03 · Draeger Medical Systems - Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath
FDA Device · Class II · 2023-05-03 · Roi Cps - VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
FDA Device · Class II · 2023-05-03 · Covidien - FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiograp…
FDA Device · Class II · 2023-05-03 · Fujifilm Healthcare Americas - Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack
FDA Device · Class II · 2023-05-03 · Roi Cps - Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack
FDA Device · Class II · 2023-05-03 · Roi Cps - JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S
FDA Device · Class II · 2023-05-03 · Spineart - stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Device · Class II · 2023-05-03 · Wright Medical Technology - VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
FDA Device · Class II · 2023-05-03 · Covidien - Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy
FDA Device · Class II · 2023-05-03 · Roi Cps - REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual
FDA Device · Class II · 2023-04-26 · Compass Health Brands Corporate Office - INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa - Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Produc…
FDA Device · Class I · 2023-04-26 · Covidien - Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - R…
FDA Device · Class II · 2023-04-26 · Olympus - MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile
FDA Device · Class II · 2023-04-26 · Medline Industries Northfield - Medtronic SenSight Extension Tunneler Kit, REF B31030
FDA Device · Class II · 2023-04-26 · Medtronic Neuromodulation - MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
FDA Device · Class II · 2023-04-26 · Biofire Diagnostics - GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA Device · Class II · 2023-04-26 · Gramercy Extremity Orthopedics - Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities
FDA Device · Class II · 2023-04-26 · Tobii Dynavox - MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1
FDA Device · Class II · 2023-04-26 · Philips Medical Systems Nederland B V - ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120
FDA Device · Class II · 2023-04-26 · Baxter Healthcare - INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa - Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
FDA Device · Class II · 2023-04-26 · Neurologica - VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versi…
FDA Device · Class II · 2023-04-26 · Ortho Clinical Diagnostics - INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa - AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and ope…
FDA Device · Class II · 2023-04-26 · Radiometer Medical Aps - SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
FDA Device · Class II · 2023-04-26 · Philips Medical Systems Nederland B V - INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa - MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm)
FDA Device · Class II · 2023-04-26 · Boston Scientific - KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver…
FDA Device · Class II · 2023-04-26 · Pro Dex - JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
FDA Device · Class II · 2023-04-26 · Smith And Nephew - Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs
FDA Device · Class II · 2023-04-26 · Beckman Coulter - Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
FDA Device · Class II · 2023-04-26 · Avanos Medical - INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024
FDA Device · Class II · 2023-04-26 · Medtronic Sofamor Danek Usa - BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform
FDA Device · Class II · 2023-04-26 · Becton Dickinson And - MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length…
FDA Device · Class II · 2023-04-19 · Edwards Lifesciences - BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
FDA Device · Class II · 2023-04-19 · Bio Rad Laboratories - Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System…
FDA Device · Class II · 2023-04-19 · Outset Medical - thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc
FDA Device · Class II · 2023-04-19 · Solta Medical - Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
FDA Device · Class I · 2023-04-19 · Fresenius Kabi Usa - EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104
FDA Device · Class II · 2023-04-19 · Encore Medical - Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - NanoKnife 5-Probe Procedure Pack 15 cm - Activation
FDA Device · Class II · 2023-04-19 · Angiodynamics - Titan Pump Assembly, Catalog Number 5177701400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
FDA Device · Class II · 2023-04-19 · Covidien - Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
FDA Device · Class II · 2023-04-19 · Covidien - Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pre…
FDA Device · Class II · 2023-04-19 · Church And Dwight - Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
FDA Device · Class III · 2023-04-19 · Agilent Technologies Us - BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
FDA Device · Class II · 2023-04-19 · Bio Rad Laboratories - Shanghai United Imaging Healthcare Co., Ltd
FDA Device · Class II · 2023-04-19 · Shanghai United Imaging Healthcare - Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Device · Class II · 2023-04-19 · Howmedica Osteonics - Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with…
FDA Device · Class II · 2023-04-19 · Western Scott Fetzer - Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Len…
FDA Device · Class II · 2023-04-19 · Edwards Lifesciences - Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
FDA Device · Class II · 2023-04-19 · Philips North America - Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
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)