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.
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm
FDA Device · Class II · 2024-08-14 · W L Gore And Associates - American Contract Systems Hand Pack convenience kit
FDA Device · Class II · 2024-08-14 · American Contract Systems - BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
FDA Device · Class II · 2024-08-14 · Siemens Medical Solutions Usa - Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
FDA Device · Class II · 2024-08-14 · Siemens Medical Solutions Usa - BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in dia…
FDA Device · Class II · 2024-08-14 · Philips Medical Systems Nederland B V - Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
FDA Device · Class II · 2024-08-14 · Baxter Healthcare - SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Repr…
FDA Device · Class II · 2024-08-14 · Steris - Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
FDA Device · Class II · 2024-08-14 · Medline Industries Northfield - American Contract Systems Biopsy Drape Pack convenience kit
FDA Device · Class II · 2024-08-14 · American Contract Systems - BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Soltive Premium SuperPulsed Laser System, Model TFL-PLS
FDA Device · Class II · 2024-08-14 · Olympus - American Contract Systems Special Procedure Pack convenience kit
FDA Device · Class II · 2024-08-14 · American Contract Systems - Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station
FDA Device · Class II · 2024-08-14 · Leica Biosystems Nussloch - SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - TruDi NAV Suction, 0 Degrees
FDA Device · Class II · 2024-08-14 · Integra Lifesciences - Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4…
FDA Device · Class I · 2024-08-14 · Covidien - BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Discovery MR950, with affected software versions: 7T23.0
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - IntelliVue Patient Monitor MX500 with L.x and M.x
FDA Device · Class II · 2024-08-14 · Philips North America - Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
FDA Device · Class II · 2024-08-14 · Luminex - American Contract Systems Spine Pack convenience kit
FDA Device · Class II · 2024-08-14 · American Contract Systems - The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size o…
FDA Device · Class II · 2024-08-14 · Olympus - SIGNA UHP, with affected software versions: RX28.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - IntelliVue Patient Monitor MX450 with L.x and M.x
FDA Device · Class II · 2024-08-14 · Philips North America - NavaClick Syringe and Needle, Model Number LIN02
FDA Device · Class III · 2024-08-14 · Lineage Biomedical - Soltive Pro SuperPulsed Laser System, Model TFL-SLS
FDA Device · Class II · 2024-08-14 · Olympus - Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors…
FDA Device · Class II · 2024-08-14 · Steris - SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope R…
FDA Device · Class II · 2024-08-14 · Steris - BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - SIGNA MR380, with affected software versions: SV25.5, SV25.6
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - CADD-Solis VIP ambulatory Infusion Pumps, Model 2110
FDA Device · Class I · 2024-08-14 · Smiths Medical Asd - CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technolo…
FDA Device · Class II · 2024-08-14 · Artivion - BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size o…
FDA Device · Class II · 2024-08-14 · Olympus - BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size o…
FDA Device · Class II · 2024-08-14 · Olympus - Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
FDA Device · Class II · 2024-08-14 · Olympus - BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - SIGNA MR360, with affected software versions: SV25.5, SV25.6
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only
FDA Device · Class II · 2024-08-07 · Becton Dickinson Infusion Therapy Systems - Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00
FDA Device · Class II · 2024-08-07 · Medivance - SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis
FDA Device · Class II · 2024-08-07 · Angiodynamics - CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty
FDA Device · Class II · 2024-08-07 · Zimmer - Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260
FDA Device · Class II · 2024-08-07 · Boston Scientific - SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis
FDA Device · Class II · 2024-08-07 · Angiodynamics - SlideView VS200 slide viewer
FDA Device · Class II · 2024-08-07 · Evident Scientific - DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination wit…
FDA Device · Class II · 2024-08-07 · Beckman Coulter Mishima K K - Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250
FDA Device · Class II · 2024-08-07 · Boston Scientific - BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Medi…
FDA Device · Class II · 2024-08-07 · Biofire Diagnostics - RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers
FDA Device · Class II · 2024-07-31 · Randox Laboratories - A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.463…
FDA Device · Class II · 2024-07-31 · Medtronic Neuromodulation - MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT)
FDA Device · Class II · 2024-07-31 · Avanos Medical - Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station
FDA Device · Class II · 2024-07-31 · Securitas Healthcare - Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas t…
FDA Device · Class II · 2024-07-31 · Securitas Healthcare - Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and adminis…
FDA Device · Class II · 2024-07-31 · Siemens Medical Solutions Usa - Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Pr…
FDA Device · Class II · 2024-07-31 · B Braun Medical - Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheter…
FDA Device · Class II · 2024-07-31 · Siemens Medical Solutions Usa - ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for…
FDA Device · Class II · 2024-07-31 · Radiometer Medical Aps - Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor S…
FDA Device · Class II · 2024-07-31 · B Braun Medical - Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perf…
FDA Device · Class II · 2024-07-31 · B Braun Medical - Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137
FDA Device · Class II · 2024-07-31 · Beckman Coulter - Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
FDA Device · Class II · 2024-07-31 · Beckman Coulter - TourniKwik Tourniquet Set (CFN 79012)
FDA Device · Class II · 2024-07-31 · Medtronic Perfusion Systems - Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
FDA Device · Class II · 2024-07-31 · Abbott Medical - Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
FDA Device · Class II · 2024-07-31 · Abbott Medical - BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-…
FDA Device · Class II · 2024-07-31 · Embecta - Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic a…
FDA Device · Class II · 2024-07-31 · Siemens Medical Solutions Usa - LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
FDA Device · Class II · 2024-07-31 · Link Bio - Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusio…
FDA Device · Class II · 2024-07-31 · B Braun Medical - NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vi…
FDA Device · Class I · 2024-07-31 · Medtronic Xomed - Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagn…
FDA Device · Class II · 2024-07-31 · Siemens Medical Solutions Usa - Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
FDA Device · Class II · 2024-07-31 · Abbott Medical - ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open,…
FDA Device · Class II · 2024-07-31 · Olympus - Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syri…
FDA Device · Class II · 2024-07-31 · B Braun Medical - Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
FDA Device · Class II · 2024-07-31 · Abbott Medical - Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of me…
FDA Device · Class II · 2024-07-24 · B Braun Medical - Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily act…
FDA Device · Class II · 2024-07-24 · Medical Depot - QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/…
FDA Device · Class II · 2024-07-24 · Qiagen Sciences
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)