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.

• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocy…
  FDA Device · Class II · 2024-05-22 · Macherey Nagel And Kg
• Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage…
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• LASER Application Instrument, 23 cm, REF: 8694
  FDA Device · Class II · 2024-05-22 · Karl Storz Endoscopy
• Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary sup…
  FDA Device · Class II · 2024-05-22 · Fresenius Medical Care Holdings
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Namic FLUID DELIVERY SET, REF 91300040
  FDA Device · Class II · 2024-05-22 · Medline Industries Northfield
• Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number…
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnost…
  FDA Device · Class II · 2024-05-22 · Philips North America
• Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045
  FDA Device · Class II · 2024-05-22 · Medline Industries Northfield
• APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg
  FDA Device · Class II · 2024-05-22 · Medartis
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
  FDA Device · Class II · 2024-05-22 · Cook Medical
• WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device
  FDA Device · Class II · 2024-05-22 · Wishbone Medical
• Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-F…
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
  FDA Device · Class II · 2024-05-22 · Fisher And Paykel Healthcare
• Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only
  FDA Device · Class II · 2024-05-22 · Lemaitre Vascular
• VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum…
  FDA Device · Class II · 2024-05-22 · Quidelortho
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• CARDIOHELP-i System
  FDA Device · Class II · 2024-05-22 · Maquet Medical Systems Usa
• TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-…
  FDA Device · Class II · 2024-05-22 · Trimed
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressu…
  FDA Device · Class II · 2024-05-22 · Sophysa
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Spectrum IQ Infusion pump, Product Code 357009
  FDA Device · Class II · 2024-05-22 · Baxter Healthcare
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
  FDA Device · Class II · 2024-05-22 · Ossur H F
• Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x
  FDA Device · Class II · 2024-05-22 · Philips North America
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic…
  FDA Device · Class II · 2024-05-22 · Philips North America
• RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
  FDA Device · Class II · 2024-05-22 · Ossur H F
• Medtronic Clearview Blower/Mister, Model Number 22120
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
  FDA Device · Class II · 2024-05-22 · Medtronic Perfusion Systems
• HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
  FDA Device · Class II · 2024-05-22 · Heartsine Technologies
• RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
  FDA Device · Class II · 2024-05-22 · Ossur H F
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressu…
  FDA Device · Class II · 2024-05-22 · Sophysa
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022
  FDA Device · Class I · 2024-05-22 · Boston Scientific
• RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
  FDA Device · Class II · 2024-05-22 · Ossur H F
• Baxter Spectrum IQ Infusion Pump, Product Code 3570009
  FDA Device · Class II · 2024-05-15 · Baxter Healthcare
• DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs…
  FDA Device · Class III · 2024-05-15 · Randox Laboratories
• DURAMAX STACKED TIP 28CM 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
• GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
  FDA Device · Class II · 2024-05-15 · Ge Medical Systems Scs
• Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinic…
  FDA Device · Class II · 2024-05-15 · Randox Laboratories
• GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
  FDA Device · Class II · 2024-05-15 · Ge Medical Systems Scs
• DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
  FDA Device · Class I · 2024-05-15 · Tandem Diabetes Care
• GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
  FDA Device · Class II · 2024-05-15 · Ge Medical Systems Scs
• DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheres…
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• DURAMAX STACKED TIP 24CM 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
• GE Healthcare Innova IGS 5, computed tomography x-ray system
  FDA Device · Class II · 2024-05-15 · Ge Medical Systems Scs
• DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheres…
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheres…
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/7…
  FDA Device · Class II · 2024-05-15 · Philips Ultrasound
• DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
  FDA Device · Class II · 2024-05-15 · Ge Medical Systems Scs
• PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55…
  FDA Device · Class II · 2024-05-15 · Spineart
• BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Ap…
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
  FDA Device · Class II · 2024-05-15 · Ge Medical Systems Scs
• Intelli-C: Right side suspended Tabletop, REF: 03400000
  FDA Device · Class II · 2024-05-15 · Nrt X Ray A S
• DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis
  FDA Device · Class II · 2024-05-15 · Angiodynamics
• Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327
  FDA Device · Class I · 2024-05-15 · Vyaire Medical
• Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only
  FDA Device · Class I · 2024-05-15 · Medtronic Navigation
• Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the crani…
  FDA Device · Class II · 2024-05-15 · Stryker Leibinger And Kg

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)