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.
- BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm…
FDA Device · Class I · 2024-05-15 · Hologic - GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Device · Class II · 2024-05-15 · Ge Medical Systems Scs - DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
FDA Device · Class II · 2024-05-15 · Angiodynamics - RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - IPS e.max ZirCAD CER/in
FDA Device · Class II · 2024-05-08 · Ivoclar Vivadent Ag - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary i…
FDA Device · Class II · 2024-05-08 · Zimmer - RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - RayStation 10.1.0.613 and 10.1.1.54
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
FDA Device · Class II · 2024-05-08 · Covidien - OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use
FDA Device · Class II · 2024-05-08 · Advanced Instruments - IPS e.max ZirCAD CER/in
FDA Device · Class II · 2024-05-08 · Ivoclar Vivadent Ag - Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Device · Class I · 2024-05-08 · Thoratec - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary int…
FDA Device · Class II · 2024-05-08 · Zimmer - RayStation 9.0.0.113 and 9.0.1.142
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteo…
FDA Device · Class II · 2024-05-08 · Zimmer - ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteoto…
FDA Device · Class II · 2024-05-08 · Zimmer - RayStation 8.0.0.61, 8.0.1.10
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties a…
FDA Device · Class II · 2024-05-08 · Olympus - RayStation 14.0.0.3338
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary int…
FDA Device · Class II · 2024-05-08 · Zimmer - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary int…
FDA Device · Class II · 2024-05-08 · Zimmer - RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
FDA Device · Class II · 2024-05-08 · Cardinal Health 200 - Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt
FDA Device · Class II · 2024-05-08 · Sedecal - Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
FDA Device · Class II · 2024-05-08 · Cardinal Health 200 - Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
FDA Device · Class II · 2024-05-08 · Alere San Diego - ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotom…
FDA Device · Class II · 2024-05-08 · Zimmer - POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties a…
FDA Device · Class II · 2024-05-08 · Olympus - IPS e.max ZirCAD CER/in
FDA Device · Class II · 2024-05-08 · Ivoclar Vivadent Ag - ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteo…
FDA Device · Class II · 2024-05-08 · Zimmer - IPS e.max ZirCAD CER/in
FDA Device · Class II · 2024-05-08 · Ivoclar Vivadent Ag - Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
FDA Device · Class II · 2024-05-08 · Cardinal Health 200 - ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteot…
FDA Device · Class II · 2024-05-08 · Zimmer - RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomie…
FDA Device · Class II · 2024-05-08 · Zimmer - ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4
FDA Device · Class II · 2024-05-08 · Advanced Research Medical - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary in…
FDA Device · Class II · 2024-05-08 · Zimmer - Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
FDA Device · Class II · 2024-05-08 · Medtronic Neuromodulation - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary int…
FDA Device · Class II · 2024-05-08 · Zimmer - ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteoto…
FDA Device · Class II · 2024-05-08 · Zimmer - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary in…
FDA Device · Class II · 2024-05-08 · Zimmer - ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteot…
FDA Device · Class II · 2024-05-08 · Zimmer - POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties a…
FDA Device · Class II · 2024-05-08 · Olympus - Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchosco…
FDA Device · Class II · 2024-05-08 · Noah Medical - IPS e.max ZirCAD CER/in
FDA Device · Class II · 2024-05-08 · Ivoclar Vivadent Ag - ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicated for temporary inte…
FDA Device · Class II · 2024-05-08 · Zimmer - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary inte…
FDA Device · Class II · 2024-05-08 · Zimmer - RayStation 7.0.0.19
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers…
FDA Device · Class II · 2024-05-08 · Covidien - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary inte…
FDA Device · Class II · 2024-05-08 · Zimmer - ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of oste…
FDA Device · Class II · 2024-05-08 · Zimmer - Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
FDA Device · Class II · 2024-05-08 · Covidien - ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary inter…
FDA Device · Class II · 2024-05-08 · Zimmer - Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a dev…
FDA Device · Class II · 2024-05-08 · Johnson And Johnson Surgical Vision - RayStation 15.0.0.430
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only
FDA Device · Class II · 2024-05-08 · Allergan Sales - INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
FDA Device · Class II · 2024-05-08 · Innomed - The Oncology Essentials Package of the Spectral CT imaging system
FDA Device · Class II · 2024-05-08 · Philips North America - RayStation 9.1.0.933 and 9.2.0.483
FDA Device · Class II · 2024-05-08 · Raysearch Laboratories Ab - Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
FDA Device · Class II · 2024-05-08 · Cardinal Health 200 - IPS e.max ZirCAD CER/in
FDA Device · Class II · 2024-05-08 · Ivoclar Vivadent Ag - The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a lue…
FDA Device · Class II · 2024-05-08 · Stryker Neurovascular - ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicated for temporary in…
FDA Device · Class II · 2024-05-08 · Zimmer - Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
FDA Device · Class II · 2024-05-08 · Abbott Medical - Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Device · Class I · 2024-05-08 · Thoratec - Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
FDA Device · Class II · 2024-05-08 · Cardinal Health 200 - Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bo…
FDA Device · Class II · 2024-05-01 · Electro Medical Systems - Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles a…
FDA Device · Class II · 2024-05-01 · Electro Medical Systems - QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
FDA Device · Class II · 2024-05-01 · Quidel - Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to…
FDA Device · Class II · 2024-05-01 · Ebi - NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System
FDA Device · Class II · 2024-05-01 · Zimmer - LightStrike Blackout Curtains, Part numbers
FDA Device · Class II · 2024-05-01 · Xenex Disinfection Services - TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neur…
FDA Device · Class I · 2024-05-01 · Route 92 Medical - TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterrupt…
FDA Device · Class II · 2024-05-01 · Philips North America - ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running…
FDA Device · Class II · 2024-05-01 · Siemens Medical Solutions Usa - Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
FDA Device · Class II · 2024-05-01 · Leica Biosystems Nussloch - TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
FDA Device · Class II · 2024-05-01 · Siemens Medical Solutions Usa - Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Ta…
FDA Device · Class II · 2024-05-01 · Covidien - TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neuro…
FDA Device · Class I · 2024-05-01 · Route 92 Medical - ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
FDA Device · Class II · 2024-05-01 · Siemens Medical Solutions Usa - Mariner RDX Polyaxial Head, REF: MX1-000020
FDA Device · Class II · 2024-05-01 · Seaspine Orthopedics - TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles…
FDA Device · Class II · 2024-05-01 · Electro Medical Systems - Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas
FDA Device · Class II · 2024-05-01 · Alcon Research - Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
FDA Device · Class II · 2024-05-01 · Baxter Healthcare - VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984
FDA Device · Class I · 2024-05-01 · Biomerieux - TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Alinity m System, Part Number: 08N53-002
FDA Device · Class II · 2024-05-01 · Abbott Molecular - 3M Durapore Surgical Tape, Catalog Number 1538-118
FDA Device · Class II · 2024-05-01 · 3m Health Care Business - TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovascula…
FDA Device · Class I · 2024-05-01 · Route 92 Medical - Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to tra…
FDA Device · Class II · 2024-05-01 · Ebi - 20" Lead Wires, Replacement Part Number: 1067724-2
FDA Device · Class II · 2024-05-01 · Ebi - TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Redux Electrolyte Creme, Product Ref. 66-04
FDA Device · Class II · 2024-05-01 · Parker Laboratories
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)