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.

• WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-7…
  FDA Device · Class II · 2023-02-15 · Wishbone Medical
• GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZ…
  FDA Device · Class I · 2023-02-15 · Ge Medical Systems Israel Functional Imaging
• TRACH PACK. Sterile Procedural Tray
  FDA Device · Class II · 2023-02-15 · Medline Industries Northfield
• Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
  FDA Device · Class II · 2023-02-15 · Medline Industries Northfield
• Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
  FDA Device · Class II · 2023-02-15 · Medline Industries Northfield
• Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTIC…
  FDA Device · Class II · 2023-02-15 · Medline Industries Northfield
• Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF
  FDA Device · Class II · 2023-02-15 · Medline Industries Northfield
• Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-…
  FDA Device · Class II · 2023-02-15 · Medline Industries Northfield
• Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841
  FDA Device · Class II · 2023-02-08 · Medtronic Perfusion Systems
• Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• AxiEM" Non-Invasive Patient Tracker
  FDA Device · Class II · 2023-02-08 · Medtronic Navigation
• Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
  FDA Device · Class II · 2023-02-08 · Syncardia Systems
• Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811
  FDA Device · Class II · 2023-02-08 · Medtronic Perfusion Systems
• CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF…
  FDA Device · Class I · 2023-02-08 · Smiths Medical Asd
• MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• Mammotome MammoStar Biopsy Site Identified, REF STAR1401
  FDA Device · Class II · 2023-02-08 · Carbon Medical Technologies
• Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841
  FDA Device · Class II · 2023-02-08 · Medtronic Perfusion Systems
• Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F…
  FDA Device · Class II · 2023-02-08 · Bard Peripheral Vascular
• Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811
  FDA Device · Class II · 2023-02-08 · Medtronic Perfusion Systems
• CADD Administration Set, List Numbers: a) REF 21-7346-24
  FDA Device · Class I · 2023-02-08 · Smiths Medical Asd
• Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
  FDA Device · Class II · 2023-02-08 · Novasignal
• BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosi…
  FDA Device · Class II · 2023-02-08 · Coopersurgical
• System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zee…
  FDA Device · Class II · 2023-02-08 · Siemens Medical Solutions Usa
• MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, inc…
  FDA Device · Class II · 2023-02-08 · Biomet
• GORE CARDIOFORM Septal Occluder, REF: GSX0030A
  FDA Device · Class II · 2023-02-08 · W L Gore And Associates
• Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
  FDA Device · Class II · 2023-02-08 · Turbett Surgical
• CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f)…
  FDA Device · Class I · 2023-02-08 · Smiths Medical Asd
• Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under t…
  FDA Device · Class I · 2023-02-08 · Universal Meditech
• CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) RE…
  FDA Device · Class I · 2023-02-08 · Smiths Medical Asd
• Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• Non-sterile procedural trays labeled as CRANI, 2 per case
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811
  FDA Device · Class II · 2023-02-08 · Medtronic Perfusion Systems
• NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Luc…
  FDA Device · Class II · 2023-02-08 · Novasignal
• CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. C…
  FDA Device · Class I · 2023-02-08 · Smiths Medical Asd
• Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811
  FDA Device · Class II · 2023-02-08 · Medtronic Perfusion Systems
• (1) Vanguard Knee System PS Open Box Femoral
  FDA Device · Class II · 2023-02-08 · Biomet
• Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
  FDA Device · Class II · 2023-02-08 · Turbett Surgical
• MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
  FDA Device · Class II · 2023-02-08 · Medline Industries Northfield
• (1) Vanguard Knee System PS Open Box Femoral
  FDA Device · Class II · 2023-02-08 · Biomet
• Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
  FDA Device · Class I · 2023-02-01 · Getinge Usa Sales
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal
  FDA Device · Class II · 2023-02-01 · Teleflex
• Single-Use Packs, REF: OPO80
  FDA Device · Class II · 2023-02-01 · Johnson And Johnson Surgical Vision
• Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal
  FDA Device · Class II · 2023-02-01 · Teleflex
• Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
  FDA Device · Class II · 2023-02-01 · Meridian Bioscience
• Alinity m System
  FDA Device · Class II · 2023-02-01 · Abbott Molecular
• FUSION Dual Pump Packs, REF: OPO73
  FDA Device · Class II · 2023-02-01 · Johnson And Johnson Surgical Vision
• AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 6030…
  FDA Device · Class II · 2023-02-01 · Sunmed Holdings
• CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
  FDA Device · Class II · 2023-02-01 · Medline Industries Northfield
• Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license
  FDA Device · Class II · 2023-02-01 · Siemens Medical Solutions Usa
• Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic
  FDA Device · Class II · 2023-02-01 · Future Diagnostics Solutions B V
• Getinge Flow-e Anesthesia System, Part No. 6887900
  FDA Device · Class I · 2023-02-01 · Getinge Usa Sales
• Agfa HealthCare Enterprise Imaging XERO Viewer
  FDA Device · Class II · 2023-02-01 · Agfa Healthcare Nv
• Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff
  FDA Device · Class II · 2023-02-01 · Teleflex
• biokitHSV-2 Rapid Test, REF: 300028001
  FDA Device · Class II · 2023-02-01 · Biokit
• MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear)
  FDA Device · Class II · 2023-02-01 · Coopervision
• Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0…
  FDA Device · Class II · 2023-02-01 · Sunmed Holdings
• Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femora…
  FDA Device · Class II · 2023-02-01 · Biomet
• Getinge Flow-c Anesthesia System, Part No. 6887700
  FDA Device · Class I · 2023-02-01 · Getinge Usa Sales
• Veritas Advanced Infusion Packs, REF: VRT-AI
  FDA Device · Class II · 2023-02-01 · Johnson And Johnson Surgical Vision
• Baxter Electrocardiograph, ELI 380 -DCS21
  FDA Device · Class II · 2023-02-01 · Baxter Healthcare
• Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
  FDA Device · Class II · 2023-02-01 · Align Technology
• R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N
  FDA Device · Class III · 2023-01-25 · R And D Systems
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
  FDA Device · Class II · 2023-01-25 · Siemens Medical Solutions Usa
• Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
  FDA Device · Class II · 2023-01-25 · Siemens Medical Solutions Usa
• Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
  FDA Device · Class II · 2023-01-25 · Siemens Medical Solutions Usa
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Vasoshield Syringe Packs, Model VH-5001
  FDA Device · Class II · 2023-01-25 · Maquet Cardiovascular
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Hemopro 2 with Vasoshield, Model VH-4001
  FDA Device · Class II · 2023-01-25 · Maquet Cardiovascular
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-…
  FDA Device · Class I · 2023-01-25 · Datascope
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems
  FDA Device · Class III · 2023-01-25 · Abbott Laboratories
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-…
  FDA Device · Class I · 2023-01-25 · Datascope
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
  FDA Device · Class II · 2023-01-25 · Bolton Medical
• Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216
  FDA Device · Class II · 2023-01-25 · Cardinal Health 200
• SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000
  FDA Device · Class I · 2023-01-25 · Cardiac Assist

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)