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.
- BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - GE Healthcare Optima 520, Catalog number 5439126
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - Ziehm Solo FD. Interventional fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan - Refer to RES or lead review memo for complete list of affected reference/catalog numbers
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - Non-ablative Fractional Laser Systems, Model: WFB-01
FDA Device · Class II · 2024-12-11 · Wingderm Electro Optics - BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190
FDA Device · Class II · 2024-12-11 · Olympus - BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - GE Healthcare Revolution EVO, Model Number 5454001-260
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile
FDA Device · Class II · 2024-12-11 · Wilson Cook Medical - Ziehm Vision R. Iterventional fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan - MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - GE Healthcare Revolution Maxima Select, Model Number, 6670000-55
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - Atellica CI Analyzer
FDA Device · Class II · 2024-12-11 · Siemens Healthcare Diagnostics - MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048…
FDA Device · Class II · 2024-12-11 · Advanced Medical Solutions - GE Healthcare Revolution Advance, Model number 5849504
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plas…
FDA Device · Class II · 2024-12-11 · Siemens Healthcare Diagnostics - MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
FDA Device · Class II · 2024-12-11 · Becton Dickinson And - GE Healthcare Revolution Ascend, Model number 6969000-100
FDA Device · Class II · 2024-12-11 · Ge Healthcare China - MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R
FDA Device · Class II · 2024-12-11 · Medline Industries Northfield - Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitte…
FDA Device · Class III · 2024-12-04 · Abbott Medical - GE Proteus XR/A radiographic system
FDA Device · Class II · 2024-12-04 · Ge Healthcare China - Achieva TX Interventional Coil 3.0T
FDA Device · Class II · 2024-12-04 · Philips North America - Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on vic…
FDA Device · Class II · 2024-12-04 · Defibtech - Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
FDA Device · Class III · 2024-12-04 · Remote Diagnostic Technologies - MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - ST SENSE Breast Coil
FDA Device · Class II · 2024-12-04 · Philips North America - MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - Offset Cup Impactor - 3/8-16 interface
FDA Device · Class II · 2024-12-04 · Incipio Devices - MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound mana…
FDA Device · Class II · 2024-12-04 · Kci Usa - Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - dS Breast 7ch 1.5T
FDA Device · Class II · 2024-12-04 · Philips North America - Mammotrak Interventional Coil 3.0T
FDA Device · Class II · 2024-12-04 · Philips North America - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Device · Class II · 2024-12-04 · Smiths Medical Asd - TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
FDA Device · Class II · 2024-12-04 · Gauthier Biomedical - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR
FDA Device · Class II · 2024-12-04 · Ge Medical Systems - dS Breast 7ch 3.0T
FDA Device · Class II · 2024-12-04 · Philips North America - Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2…
FDA Device · Class II · 2024-12-04 · Defibtech - AMS Artificial Urinary Sphincter Control Pump
FDA Device · Class II · 2024-12-04 · Boston Scientific - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (D…
FDA Device · Class II · 2024-12-04 · Defibtech - Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted hear…
FDA Device · Class III · 2024-12-04 · Abbott Medical - MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
FDA Device · Class II · 2024-12-04 · Shimadzu Analytical And Measuring Instruments Div - Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Appli…
FDA Device · Class II · 2024-12-04 · Securitas Healthcare - Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use…
FDA Device · Class II · 2024-12-04 · Defibtech - Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/C…
FDA Device · Class II · 2024-12-04 · Microsurgical Technology - AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
FDA Device · Class II · 2024-12-04 · Boston Scientific - SIGNA Architect, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2024-12-04 · Ge Medical Systems - Mammotrak Diagnostic Coil 3.0T
FDA Device · Class II · 2024-12-04 · Philips North America - RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing…
FDA Device · Class II · 2024-12-04 · Smith And Nephew Medical - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - Mammotrak Interventional Coil 1.5T
FDA Device · Class II · 2024-12-04 · Philips North America - SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
FDA Device · Class II · 2024-12-04 · Ge Medical Systems - SENSE Breast Coil
FDA Device · Class II · 2024-12-04 · Philips North America - MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - Mammotrak Diagnostic Coil 1.5T
FDA Device · Class II · 2024-12-04 · Philips North America - MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasm…
FDA Device · Class II · 2024-12-04 · Ortho Clinical Diagnostics - MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
FDA Device · Class II · 2024-12-04 · Shimadzu Analytical And Measuring Instruments Div - dS Breast 16ch 3.0T
FDA Device · Class II · 2024-12-04 · Philips North America - Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide int…
FDA Device · Class III · 2024-12-04 · Zyno Medical - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
FDA Device · Class II · 2024-12-04 · Smiths Medical Asd - dS Breast 16ch 1.5T
FDA Device · Class II · 2024-12-04 · Philips North America - Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
FDA Device · Class II · 2024-12-04 · Kreatech Biotechnology Bv - SENSE Breast Coil 3.0T 7ch
FDA Device · Class II · 2024-12-04 · Philips North America - Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Device · Class II · 2024-12-04 · Micro X - smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Device · Class II · 2024-12-04 · Smiths Medical Asd - BioZorb Marker
FDA Device · Class I · 2024-12-04 · Hologic - ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield - Discovery MR750w 3.0T, whole body magnetic resonance scanner
FDA Device · Class II · 2024-12-04 · Ge Medical Systems - Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
FDA Device · Class II · 2024-12-04 · Livanova Deutschland - ST SENSE Breast Dx Coil
FDA Device · Class II · 2024-12-04 · Philips North America - Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482
FDA Device · Class II · 2024-12-04 · Baxter Healthcare - Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile
FDA Device · Class II · 2024-12-04 · Medline Industries Northfield
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)