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.
- CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of so…
FDA Device · Class II · 2024-07-03 · Integra Lifesciences - EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa - SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems
FDA Device · Class I · 2024-07-03 · Philips North America - AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radio…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa - AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radi…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa - MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa - COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa - NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
FDA Device · Class II · 2024-07-03 · Novasignal - CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-0…
FDA Device · Class II · 2024-07-03 · Ge Healthcare Finland Oy - 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, p…
FDA Device · Class II · 2024-07-03 · Thoratec Switzerland - CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102
FDA Device · Class II · 2024-07-03 · Ge Healthcare Finland Oy - Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407
FDA Device · Class II · 2024-07-03 · Draeger Medical Systems - CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6)…
FDA Device · Class II · 2024-07-03 · Ge Healthcare Finland Oy - CARESCAPE Canvas 1000, Model Numbers: a) 5865770
FDA Device · Class II · 2024-07-03 · Ge Healthcare Finland Oy - Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F…
FDA Device · Class II · 2024-07-03 · Merit Medical Systems - COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outp…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa - AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radi…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa - COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French
FDA Device · Class II · 2024-07-03 · Mermaid Medical A S - Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China)…
FDA Device · Class II · 2024-07-03 · Siemens Healthcare Diagnostics - MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is use…
FDA Device · Class II · 2024-07-03 · Dental Ez Group Star Dental Division - Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope
FDA Device · Class II · 2024-07-03 · Maquet Cardiovascular - MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA Device · Class II · 2024-07-03 · Centers For Disease Control And Prevention - Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety o…
FDA Device · Class II · 2024-07-03 · Cook - MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems
FDA Device · Class I · 2024-07-03 · Philips North America - Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System
FDA Device · Class II · 2024-07-03 · Stryker - EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radi…
FDA Device · Class II · 2024-07-03 · Siemens Medical Solutions Usa - COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
FDA Device · Class II · 2024-07-03 · Biomet - MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / MAEP2, c) 5514418-01059642, d) 5514418-01080402, e) 5514418-0108131…
FDA Device · Class II · 2024-07-03 · Ge Healthcare Finland Oy - NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
FDA Device · Class II · 2024-07-03 · Novasignal - Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
FDA Device · Class II · 2024-07-03 · Medtronic - OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM
FDA Device · Class II · 2024-06-26 · Exactech - OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM
FDA Device · Class II · 2024-06-26 · Exactech - Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
FDA Device · Class II · 2024-06-26 · Beaver Visitec International - NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-4…
FDA Device · Class II · 2024-06-26 · Nxstage Medical - ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows: Part…
FDA Device · Class I · 2024-06-26 · Zoll Medical - PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, i…
FDA Device · Class II · 2024-06-26 · Ethicon - VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surge…
FDA Device · Class II · 2024-06-26 · Ethicon - HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
FDA Device · Class II · 2024-06-26 · Howmedica Osteonics - OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM
FDA Device · Class II · 2024-06-26 · Exactech - Ventilator HAMILTON-C6, PN: 160021
FDA Device · Class I · 2024-06-26 · Hamilton Medical Ag - Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
FDA Device · Class II · 2024-06-26 · Beaver Visitec International - OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM
FDA Device · Class II · 2024-06-26 · Exactech - MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an abs…
FDA Device · Class II · 2024-06-26 · Ethicon - MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is…
FDA Device · Class II · 2024-06-26 · Ethicon - Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat…
FDA Device · Class II · 2024-06-26 · Baxter Healthcare - VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for oph…
FDA Device · Class II · 2024-06-26 · Ethicon - TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15-…
FDA Device · Class II · 2024-06-26 · Outset Medical - PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiova…
FDA Device · Class II · 2024-06-26 · Ethicon - Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM
FDA Device · Class II · 2024-06-26 · C R Bard - Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
FDA Device · Class II · 2024-06-26 · Howmedica Osteonics - Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Par…
FDA Device · Class II · 2024-06-19 · Wondfo Usa - CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionall…
FDA Device · Class II · 2024-06-19 · Integra Lifesciences - Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) C…
FDA Device · Class II · 2024-06-19 · Wondfo Usa - Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
FDA Device · Class II · 2024-06-19 · Wondfo Usa - CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatib…
FDA Device · Class II · 2024-06-19 · Integra Lifesciences - Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286…
FDA Device · Class I · 2024-06-19 · Thoratec - MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emissi…
FDA Device · Class II · 2024-06-19 · Ge Medical Systems Israel Functional Imaging - Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
FDA Device · Class II · 2024-06-19 · B Braun Medical - CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used wi…
FDA Device · Class II · 2024-06-19 · Integra Lifesciences - NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-…
FDA Device · Class III · 2024-06-19 · Avanos Medical - CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial…
FDA Device · Class II · 2024-06-19 · Blue Belt Technologies - Aeos Robotic Digital Microscope, Product Code: PV010
FDA Device · Class II · 2024-06-19 · Aesculap - MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MR…
FDA Device · Class II · 2024-06-19 · Canon Medical System Usa - EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
FDA Device · Class II · 2024-06-19 · Covidien - OMTech Desktop Laser Engraver
FDA Device · Class II · 2024-06-19 · Rygel Advanced Machines - VITROS Immunodiagnostic Products Anti HBs Calibrators
FDA Device · Class II · 2024-06-19 · Ortho Clinical Diagnostics - Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251
FDA Device · Class II · 2024-06-19 · B Braun Medical - Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
FDA Device · Class II · 2024-06-19 · B Braun Medical - US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius…
FDA Device · Class II · 2024-06-19 · Fresenius Medical Care Holdings - Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
FDA Device · Class II · 2024-06-19 · B Braun Medical - Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One S…
FDA Device · Class II · 2024-06-19 · Wondfo Usa - Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal…
FDA Device · Class II · 2024-06-19 · Mckesson Medical Surgical Corporate Office - Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
FDA Device · Class II · 2024-06-19 · Young Dental Manufacturing I - NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC…
FDA Device · Class III · 2024-06-19 · Avanos Medical - NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA…
FDA Device · Class III · 2024-06-19 · Avanos Medical - Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo…
FDA Device · Class II · 2024-06-19 · Wondfo Usa - FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fl…
FDA Device · Class II · 2024-06-12 · Bd Switzerland Sarl - MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
FDA Device · Class II · 2024-06-12 · Medline Industries Northfield - FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical
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)