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.
- 48" Lead Wires, Replacement Part Number: 1067724-4
FDA Device · Class II · 2024-05-01 · Ebi - Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended…
FDA Device · Class II · 2024-05-01 · Covidien - Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle s…
FDA Device · Class II · 2024-05-01 · Seaspine Orthopedics - TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into th…
FDA Device · Class I · 2024-05-01 · Route 92 Medical - Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM
FDA Device · Class II · 2024-05-01 · Biomet - TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions
FDA Device · Class II · 2024-05-01 · Ion Beam Applications - Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculatu…
FDA Device · Class I · 2024-05-01 · Route 92 Medical - TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
FDA Device · Class II · 2024-05-01 · Quidel - TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
FDA Device · Class II · 2024-05-01 · Howmedica Osteonics - Evolution Upgrade 3.0T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring
FDA Device · Class I · 2024-04-24 · Sonarmed - Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-21…
FDA Device · Class II · 2024-04-24 · Baxter Healthcare - Ingenia 3.0T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring
FDA Device · Class I · 2024-04-24 · Sonarmed - Trilogy EV300, all software versions except 1.05.06.00
FDA Device · Class I · 2024-04-24 · Philips Respironics - Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devi…
FDA Device · Class II · 2024-04-24 · Cook - GYROSCAN ACS-NT, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Trilogy Evo, all software versions except 1.05.06.00
FDA Device · Class I · 2024-04-24 · Philips Respironics - Intera 1.5T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labele…
FDA Device · Class I · 2024-04-24 · Elekta Instrument Ab - Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vas…
FDA Device · Class II · 2024-04-24 · Cook - Intera 1.5T Achieva Nova, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - SmartPath to dStream for XR and 3.0T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Ingenia Elition X, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f…
FDA Device · Class II · 2024-04-24 · Smiths Medical Asd - Achieva 3.0TX for PET, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Achieva 1.5T Conversion, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Intera Achieva 1.5T Pulsar, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - GYROSCAN T5, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis
FDA Device · Class II · 2024-04-24 · Cook - Intera CV, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular app…
FDA Device · Class II · 2024-04-24 · Cook - Intera 1.0T Power/Pulsar, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Intera 1.5T R11, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound h…
FDA Device · Class II · 2024-04-24 · Smith And Nephew Medical - Achieva XR, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring
FDA Device · Class I · 2024-04-24 · Sonarmed - RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound h…
FDA Device · Class II · 2024-04-24 · Smith And Nephew Medical - Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only
FDA Device · Class II · 2024-04-24 · Masimo - Intera 1.5T Omni/Stellar, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M…
FDA Device · Class II · 2024-04-24 · Ethicon - Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only
FDA Device · Class II · 2024-04-24 · Masimo - Trilogy Evo O2, all software versions except 1.05.06.00
FDA Device · Class I · 2024-04-24 · Philips Respironics - MR 5300, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Achieva 1.5T Initial, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Ingenia 1.5T CX, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into centra…
FDA Device · Class II · 2024-04-24 · Cook - LifeVentEVO2, all software versions except 1.05.06.00
FDA Device · Class I · 2024-04-24 · Philips Respironics - Intera 1.0T Omni/Stellar, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 40…
FDA Device · Class II · 2024-04-24 · Smiths Medical Asd - GYROSCAN T5-NT, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Identity Imprint PS Tibial Tray Size 4: Lot 540287
FDA Device · Class II · 2024-04-24 · Conformis - Achieva 3.0T for PET, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - SmartPath to dStream for 1.5T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Chiba Biopsy Needle - Used for aspiration biopsy
FDA Device · Class II · 2024-04-24 · Cook - GYROSCAN T10-NT, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00
FDA Device · Class I · 2024-04-24 · Philips Respironics - Ingenia 1.5T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
FDA Device · Class II · 2024-04-24 · Smiths Medical Asd - Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
FDA Device · Class I · 2024-04-24 · Outset Medical - Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Intera 1.5T Power/Pulsar, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - MR 7700, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee mul…
FDA Device · Class II · 2024-04-24 · Siemens Medical Solutions Usa - Achieva 3.0T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
FDA Device · Class II · 2024-04-24 · Randox Laboratories - SW Bari Lift & Transfer, Model Number 38060000
FDA Device · Class II · 2024-04-24 · Raye S - Intera 1.5T Master/Nova, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-21…
FDA Device · Class II · 2024-04-24 · Baxter Healthcare - Neria Soft Infusion Set, Product Code 507302, intravascular administration set
FDA Device · Class II · 2024-04-24 · Unomedical A S - Ingenia Ambition S, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Ingenia Elition S, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Intera 3.0T Quasar Dual, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Enterprise 1.5T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
FDA Device · Class II · 2024-04-24 · Randox Laboratories - Aeris EVO, all software versions except 1.05.06.00
FDA Device · Class I · 2024-04-24 · Philips Respironics - Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall…
FDA Device · Class II · 2024-04-24 · Cook - Intera 1.5T Achieva IT Nova, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vasc…
FDA Device · Class II · 2024-04-24 · Cook - Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
FDA Device · Class II · 2024-04-24 · Smiths Medical Asd - Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-21…
FDA Device · Class II · 2024-04-24 · Baxter Healthcare - Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using th…
FDA Device · Class II · 2024-04-24 · Siemens Healthcare Diagnostics - Ingenia Ambition X, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Intera 0.5T Standard, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Garbin EVO, all software versions except 1.05.06.00
FDA Device · Class I · 2024-04-24 · Philips Respironics - Achieva 1.5T, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
FDA Device · Class II · 2024-04-24 · Surgical Specialties - AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring
FDA Device · Class I · 2024-04-24 · Sonarmed - Ingenia 3.0T CX, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - CryoValve SG Cryopreserved Pulmonary Human Heart Valve
FDA Device · Class II · 2024-04-24 · Artivion - Actim PROM dipstik, REF 30831ETUS
FDA Device · Class II · 2024-04-24 · Actim Oy - Ingenia 1.5T S, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only
FDA Device · Class II · 2024-04-24 · Masimo - Dr¿ger Perseus A500 Anesthesia Workstation
FDA Device · Class I · 2024-04-24 · Draeger Medical - Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System
FDA Device · Class II · 2024-04-24 · Philips North America - Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only
FDA Device · Class II · 2024-04-24 · Masimo - Chromophare Surgical Light System , REF CH00000001
FDA Device · Class II · 2024-04-17 · Stryker Communications
Other years
2026 (2,088) · 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)