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.
- MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755
FDA Device · Class I · 2024-10-09 · Medtronic Minimed - BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339
FDA Device · Class II · 2024-10-09 · Becton Dickinson And Bd Bio Sciences - ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
FDA Device · Class II · 2024-10-09 · Siemens Healthcare Diagnostics - DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
FDA Device · Class II · 2024-10-09 · Feng Chun Yuan Medical Equipment Shenzhen - DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
FDA Device · Class II · 2024-10-09 · Feng Chun Yuan Medical Equipment Shenzhen - DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere
FDA Device · Class II · 2024-10-09 · Alcon Research - IntelliVue G7m Anesthesia Gas Module, Product Number 866173
FDA Device · Class II · 2024-10-09 · Philips North America - MiniMed Insulin Pump Device
FDA Device · Class I · 2024-10-09 · Medtronic Minimed - BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presb…
FDA Device · Class II · 2024-10-09 · Coopervision - BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution
FDA Device · Class II · 2024-10-09 · Young Dental Manufacturing I - Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
FDA Device · Class II · 2024-10-09 · Siemens Healthcare Diagnostics - Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only
FDA Device · Class I · 2024-10-09 · Percussionaire - Neo-Tee T-Piece Resuscitator
FDA Device · Class I · 2024-10-09 · Mercury Enterprises - Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) wi…
FDA Device · Class II · 2024-10-09 · Coopervision - DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system
FDA Device · Class II · 2024-10-09 · Philips North America - Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip
FDA Device · Class II · 2024-10-09 · Healgen Scientific - paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Device · Class I · 2024-10-02 · Smiths Medical Asd - Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa
FDA Device · Class II · 2024-10-02 · Coopersurgical - AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for ma…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy - WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintainin…
FDA Device · Class II · 2024-10-02 · Boston Scientific - PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and…
FDA Device · Class II · 2024-10-02 · Fisher And Paykel Healthcare - BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria
FDA Device · Class II · 2024-10-02 · Becton Dickinson And - Stainless Steel Sims Uterine Sound, Part Number 64-601
FDA Device · Class II · 2024-10-02 · Coopersurgical - Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as fo…
FDA Device · Class II · 2024-10-02 · Hologic - PACEMAKER PACK, SLCV01J
FDA Device · Class II · 2024-10-02 · American Contract Systems - WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining e…
FDA Device · Class II · 2024-10-02 · Boston Scientific - WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining…
FDA Device · Class II · 2024-10-02 · Boston Scientific - AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for ma…
FDA Device · Class II · 2024-10-02 · Boston Scientific - WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Custodiol HTK Solution, 500ml bottle. 10 per carton
FDA Device · Class II · 2024-10-02 · Dr Franz Koehler Chemie - WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining…
FDA Device · Class II · 2024-10-02 · Boston Scientific - ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software
FDA Device · Class II · 2024-10-02 · Siemens Medical Solutions Usa - prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
FDA Device · Class II · 2024-10-02 · Centinel Spine - WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining…
FDA Device · Class II · 2024-10-02 · Boston Scientific - WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining e…
FDA Device · Class II · 2024-10-02 · Boston Scientific - BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically signific…
FDA Device · Class II · 2024-10-02 · Becton Dickinson And - Endovascular AAA Pack, ESED52B
FDA Device · Class II · 2024-10-02 · American Contract Systems - prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
FDA Device · Class II · 2024-10-02 · Centinel Spine - Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas
FDA Device · Class II · 2024-10-02 · Cook Biotech - ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software
FDA Device · Class II · 2024-10-02 · Siemens Medical Solutions Usa - Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas
FDA Device · Class II · 2024-10-02 · Cook Biotech - Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF:…
FDA Device · Class II · 2024-10-02 · Tmj Solutions - Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal stru…
FDA Device · Class II · 2024-10-02 · Philips North America - WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Bilateral Tubal Ligation Pack, FHBT3T
FDA Device · Class II · 2024-10-02 · American Contract Systems - IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 86606…
FDA Device · Class II · 2024-10-02 · Philips North America - WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining e…
FDA Device · Class II · 2024-10-02 · Boston Scientific - AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for ma…
FDA Device · Class II · 2024-10-02 · Boston Scientific - WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esopha…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Custom Procedure Kit, REF: K12T-11077
FDA Device · Class II · 2024-10-02 · Merit Medical Systems - AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for m…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Cath Lab Pack, CECL02P
FDA Device · Class II · 2024-10-02 · American Contract Systems - CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons
FDA Device · Class I · 2024-10-02 · Datascope - Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy - Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structu…
FDA Device · Class II · 2024-10-02 · Philips North America - Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal s…
FDA Device · Class II · 2024-10-02 · Philips North America - WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining e…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Day Surgery General Pack, FHGE18T
FDA Device · Class II · 2024-10-02 · American Contract Systems - Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-040…
FDA Device · Class II · 2024-10-02 · Arrow International - WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintainin…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal s…
FDA Device · Class II · 2024-10-02 · Philips North America - BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-208…
FDA Device · Class II · 2024-10-02 · Argon Medical Devices - SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of th…
FDA Device · Class II · 2024-10-02 · Philips North America - WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for mainta…
FDA Device · Class II · 2024-10-02 · Boston Scientific - AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures…
FDA Device · Class II · 2024-10-02 · Stryker Spine - Neuro Vascular, ANKV91A
FDA Device · Class II · 2024-10-02 · American Contract Systems - Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy - CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons
FDA Device · Class I · 2024-10-02 · Datascope - Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy - WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintai…
FDA Device · Class II · 2024-10-02 · Boston Scientific - (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile
FDA Device · Class II · 2024-10-02 · Cardinal Health 200 - WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining e…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
FDA Device · Class II · 2024-10-02 · Coopersurgical - WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining e…
FDA Device · Class II · 2024-10-02 · Boston Scientific - WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining e…
FDA Device · Class II · 2024-10-02 · Boston Scientific - SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra…
FDA Device · Class II · 2024-10-02 · Philips North America - Endovascular AAA Pack, ESED52B
FDA Device · Class II · 2024-10-02 · American Contract Systems - BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and n…
FDA Device · Class II · 2024-10-02 · Bard Peripheral Vascular - Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy - WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining…
FDA Device · Class II · 2024-10-02 · Boston Scientific - GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518
FDA Device · Class II · 2024-10-02 · Wipro Ge Healthcare Private - paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Device · Class I · 2024-10-02 · Smiths Medical Asd - Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the intern…
FDA Device · Class II · 2024-10-02 · Philips North America - Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas
FDA Device · Class II · 2024-10-02 · Cook Biotech - Nasal Sinus Pack, MTSN26B
FDA Device · Class II · 2024-10-02 · American Contract Systems - CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons
FDA Device · Class I · 2024-10-02 · Datascope - The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital…
FDA Device · Class II · 2024-10-02 · Fujifilm Healthcare Americas - Cysto, FTCY03L
FDA Device · Class II · 2024-10-02 · American Contract Systems - AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for m…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
FDA Device · Class II · 2024-10-02 · Karl Storz Endoscopy - ENT, COEN27N
FDA Device · Class II · 2024-10-02 · American Contract Systems - MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of…
FDA Device · Class II · 2024-10-02 · Philips North America - WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/o…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structur…
FDA Device · Class II · 2024-10-02 · Philips North America - AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for ma…
FDA Device · Class II · 2024-10-02 · Boston Scientific - Paracentesis Thoracente, SLPT76H
FDA Device · Class II · 2024-10-02 · American Contract Systems - LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
FDA Device · Class II · 2024-10-02 · Waldemar Link And Kg Hq - SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the…
FDA Device · Class II · 2024-10-02 · Philips North America - Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
FDA Device · Class II · 2024-10-02 · Merit Medical Systems
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)