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.
- Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Numb…
FDA Device · Class II · 2024-04-10 · Exactech - Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32,…
FDA Device · Class II · 2024-04-10 · Exactech - Phantom 2 Nasal Vented Mask
FDA Device · Class I · 2024-04-10 · Sleepnet - Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Num…
FDA Device · Class II · 2024-04-10 · Exactech - stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
FDA Device · Class II · 2024-04-10 · Wright Medical Technology - Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
FDA Device · Class II · 2024-04-10 · Covidien - MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
FDA Device · Class II · 2024-04-10 · Exactech - Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
FDA Device · Class II · 2024-04-10 · Medline Industries Northfield - Trumpet, Needle Guide, Cat# TMS-200
FDA Device · Class II · 2024-04-10 · Technicality - Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium,…
FDA Device · Class II · 2024-04-10 · Exactech - CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
FDA Device · Class II · 2024-04-03 · Philips North America - stay-safe /Luer Lock Catheter Ext. 12 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
FDA Device · Class I · 2024-04-03 · Boston Scientific - stay-safe /Luer Lock Catheter Ext. 18 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
FDA Device · Class II · 2024-04-03 · Baxter Healthcare - Thermalon Sinus Compress, Item Number 24332
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - stay-safe /Luer Catheter Ext. 6 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - OptiCross Coronary Imaging Catheter, REF H749518080120
FDA Device · Class II · 2024-04-03 · Boston Scientific - MediBeads Neck Wrap, Item Number 34320
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile
FDA Device · Class II · 2024-04-03 · Medical Action Industries 306 - Thermalon Eye Compress, Item Number 2434
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
FDA Device · Class I · 2024-04-03 · Boston Scientific - Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
FDA Device · Class II · 2024-04-03 · Boston Scientific - Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
FDA Device · Class II · 2024-04-03 · Baxter Healthcare - Thermalon Back Wrap, Item Number 24312
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - O.T.D - Optimum Traction Device - Street Orange
FDA Device · Class II · 2024-04-03 · Emergency Products And Research - SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-…
FDA Device · Class II · 2024-04-03 · Alcon Research - RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part nu…
FDA Device · Class II · 2024-04-03 · Bolton Medical - stay-safe /Safe Lock Catheter Ext. 12 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - Insufflation unit, UHI-4
FDA Device · Class II · 2024-04-03 · Olympus - HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H
FDA Device · Class II · 2024-04-03 · Puritan Medical Products - Thermalon Neck Wrap, Item Number 24322
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - Access Substrate, REF 81906, For use with the Access Immunoassay Systems
FDA Device · Class II · 2024-04-03 · Beckman Coulter - GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
FDA Device · Class I · 2024-04-03 · Deroyal Industries - VITROS Performance Verifier II
FDA Device · Class II · 2024-04-03 · Ortho Clinical Diagnostics - Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Numb…
FDA Device · Class II · 2024-04-03 · Randox Laboratories - Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
FDA Device · Class II · 2024-04-03 · Baxter Healthcare - Thermalon Stye Compress, Item Number 24352
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - Nimbus II Infusion System
FDA Device · Class I · 2024-04-03 · Infutronix - Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version…
FDA Device · Class II · 2024-04-03 · Philips North America - stay-safe /Luer Lock Adapter 4 in
FDA Device · Class I · 2024-04-03 · Fresenius Medical Care Holdings - Thermalon Sinus Compress (French), Item Number 24332F
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Device · Class II · 2024-04-03 · Bio Rad Laboratories - Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
FDA Device · Class II · 2024-04-03 · Medivance - VITROS Performance Verifier I
FDA Device · Class II · 2024-04-03 · Ortho Clinical Diagnostics - Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
FDA Device · Class II · 2024-04-03 · Baxter Healthcare - Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Rea…
FDA Device · Class II · 2024-04-03 · Hologic - InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery
FDA Device · Class II · 2024-04-03 · Olympus - Epix Universal Clip Applier, REF: CA500, STERILEEO
FDA Device · Class II · 2024-04-03 · Applied Medical Resources - Thermalon Heating Pad, Item Number 24002
FDA Device · Class II · 2024-04-03 · Bruder Healthcare - Nimbus Administration Set
FDA Device · Class I · 2024-04-03 · Infutronix - SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
FDA Device · Class II · 2024-04-03 · Olympus - SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
FDA Device · Class II · 2024-04-03 · Olympus - Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT L…
FDA Device · Class II · 2024-04-03 · Applied Medical Resources - NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide…
FDA Device · Class II · 2024-03-27 · Mc3 - MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
FDA Device · Class II · 2024-03-27 · Baxter Healthcare - HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS I…
FDA Device · Class I · 2024-03-27 · Thoratec - MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (…
FDA Device · Class I · 2024-03-27 · Thoratec - Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
FDA Device · Class II · 2024-03-27 · Mckesson Medical Surgical Corporate Office - Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
FDA Device · Class II · 2024-03-27 · Mckesson Medical Surgical Corporate Office - Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
FDA Device · Class II · 2024-03-27 · Covidien - smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Device · Class I · 2024-03-27 · Smiths Medical Asd - Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
FDA Device · Class II · 2024-03-27 · Preat - Assembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used with the TMINI Miniature Robotic System
FDA Device · Class II · 2024-03-27 · Think Surgical - Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Le…
FDA Device · Class II · 2024-03-27 · Mckesson Medical Surgical Corporate Office - Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency
FDA Device · Class II · 2024-03-27 · Sarnova Hc - MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - Medtronic DLP Vessel Cannula, Model Number REF 30000
FDA Device · Class II · 2024-03-27 · Medtronic Perfusion Systems - Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090
FDA Device · Class II · 2024-03-27 · Medtronic - microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10…
FDA Device · Class II · 2024-03-27 · Landauer - smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Device · Class I · 2024-03-27 · Smiths Medical Asd - Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
FDA Device · Class II · 2024-03-27 · D O R C Dutch Opthalmic Research Center Intl B V - natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
FDA Device · Class II · 2024-03-27 · Natus Neurology - MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
FDA Device · Class II · 2024-03-27 · D O R C Dutch Opthalmic Research Center Intl B V - MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency
FDA Device · Class II · 2024-03-27 · Sarnova Hc - ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220
FDA Device · Class I · 2024-03-27 · Arrow International - Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
FDA Device · Class II · 2024-03-27 · Mckesson Medical Surgical Corporate Office - Liquid Protein Calibrators
FDA Device · Class II · 2024-03-27 · Randox Laboratories - MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - C…
FDA Device · Class II · 2024-03-27 · Angiodynamics - MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - TENSIVE Conductive Adhesive Gel, REF 016-401600
FDA Device · Class II · 2024-03-27 · Natus Neurology - MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - Access Total T4, REF 33800, IVD, thyroxine reagent assay
FDA Device · Class II · 2024-03-27 · Beckman Coulter - MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
FDA Device · Class II · 2024-03-27 · Angiodynamics - MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system
FDA Device · Class II · 2024-03-27 · Angiodynamics - I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
FDA Device · Class II · 2024-03-27 · In2bones Sas - I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
FDA Device · Class II · 2024-03-27 · In2bones Sas - DCA Systems HbA1c Reagent Kit
FDA Device · Class II · 2024-03-27 · Siemens Healthcare Diagnostics
Other years
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