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.
- Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G
FDA Device · Class II · 2024-02-07 · American Contract Systems - SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105
FDA Device · Class II · 2024-02-07 · Philips North America - MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
FDA Device · Class II · 2024-02-07 · Medline Industries Northfield - RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - smiths medical Medfusion Model 4000 syringe pump
FDA Device · Class I · 2024-02-07 · Smiths Medical Asd - SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - EZDilate Wire Guided Balloon 18-19-20
FDA Device · Class II · 2024-02-07 · Olympus - LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
FDA Device · Class II · 2024-02-07 · Medline Industries Northfield - Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345
FDA Device · Class II · 2024-02-07 · Philips North America - SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C
FDA Device · Class II · 2024-02-07 · American Contract Systems - Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52
FDA Device · Class II · 2024-02-07 · American Contract Systems - EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescent…
FDA Device · Class II · 2024-02-07 · Olympus - HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
FDA Device · Class I · 2024-02-07 · Datex Ohmeda - EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12…
FDA Device · Class II · 2024-02-07 · Olympus - PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L
FDA Device · Class II · 2024-02-07 · American Contract Systems - SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F
FDA Device · Class II · 2024-02-07 · American Contract Systems - Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 B…
FDA Device · Class II · 2024-02-07 · Covidien - HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
FDA Device · Class II · 2024-02-07 · Philips Medical Systems Nederland B V - SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129
FDA Device · Class II · 2024-02-07 · Philips North America - SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
FDA Device · Class II · 2024-02-07 · American Contract Systems - SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112
FDA Device · Class II · 2024-02-07 · Philips North America - MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
FDA Device · Class II · 2024-02-07 · Medline Industries Northfield - Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
FDA Device · Class II · 2024-02-07 · Vortex Surgical - Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J
FDA Device · Class II · 2024-02-07 · American Contract Systems - EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849
FDA Device · Class I · 2024-02-07 · Datex Ohmeda - Achieva XR. Model (REF) Numbers 781153, 781253
FDA Device · Class II · 2024-02-07 · Philips North America - Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V
FDA Device · Class II · 2024-02-07 · American Contract Systems - MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
FDA Device · Class II · 2024-02-07 · Medline Industries Northfield - SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM"
FDA Device · Class II · 2024-02-07 · Aesculap - ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping…
FDA Device · Class II · 2024-02-07 · Ethicon Endo Surgery - NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
FDA Device · Class II · 2024-02-07 · Thor Photomedicine - EZDilate Fixed Wire Balloon 11-12-13
FDA Device · Class II · 2024-02-07 · Olympus - SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
FDA Device · Class II · 2024-02-07 · Atricure - Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261
FDA Device · Class II · 2024-02-07 · Philips North America - Terragene Bionova PCD (PCD222-C)
FDA Device · Class II · 2024-02-07 · Terragene - SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
FDA Device · Class II · 2024-02-07 · Atricure - EZDilate Fixed Wire Balloon 18-19-20
FDA Device · Class II · 2024-02-07 · Olympus - SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Achieva 1.5T Conversion
FDA Device · Class II · 2024-02-07 · Philips North America - DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
FDA Device · Class II · 2024-02-07 · Philips Medical Systems Nederland B V - Achieva 1.5T Initial system
FDA Device · Class II · 2024-02-07 · Philips North America - Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J
FDA Device · Class II · 2024-02-07 · American Contract Systems - Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E
FDA Device · Class II · 2024-02-07 · American Contract Systems - Volar Bearing Plate
FDA Device · Class II · 2024-02-07 · Trimed - DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
FDA Device · Class II · 2024-02-07 · Microvention - LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
FDA Device · Class II · 2024-02-07 · Medline Industries Northfield - Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J
FDA Device · Class II · 2024-02-07 · American Contract Systems - SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12…
FDA Device · Class II · 2024-02-07 · Olympus - DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - EZDilate Wire Guided Balloon 11-12-13
FDA Device · Class II · 2024-02-07 · Olympus - MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
FDA Device · Class II · 2024-02-07 · Aesculap - RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Cortera Spinal Fixation System, REF: 150100-85050
FDA Device · Class II · 2024-02-07 · Xtant Medical Holdings - SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
FDA Device · Class II · 2024-01-31 · C R Bard - Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile
FDA Device · Class II · 2024-01-31 · Tornier - Intera 1.5T, Model No. 781195
FDA Device · Class III · 2024-01-31 · Philips North America - VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrat…
FDA Device · Class II · 2024-01-31 · Ortho Clinical Diagnostics - iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3…
FDA Device · Class II · 2024-01-31 · Beckman Coulter - Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
FDA Device · Class II · 2024-01-31 · C R Bard - PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necess…
FDA Device · Class II · 2024-01-31 · Hologic - Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
FDA Device · Class II · 2024-01-31 · C R Bard - Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
FDA Device · Class II · 2024-01-31 · C R Bard - Ingenia Ambition X, Model No. 782109
FDA Device · Class III · 2024-01-31 · Philips North America - Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
FDA Device · Class II · 2024-01-31 · C R Bard - REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
FDA Device · Class II · 2024-01-31 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kim Ur San Ve Tic A S - Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
FDA Device · Class II · 2024-01-31 · C R Bard - Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
FDA Device · Class II · 2024-01-31 · C R Bard - SmartPath to dStream for 1.5T, Model No. 781260, 782112
FDA Device · Class III · 2024-01-31 · Philips North America - iQ Waste Well Adapter, Part Number: 700-3393
FDA Device · Class II · 2024-01-31 · Beckman Coulter - Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120
FDA Device · Class II · 2024-01-31 · C R Bard - Bard¿ Suction Connector with ENFit, REF EN0066000
FDA Device · Class II · 2024-01-31 · C R Bard - DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
FDA Device · Class II · 2024-01-31 · Diasorin - Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
FDA Device · Class II · 2024-01-31 · C R Bard - Power Knee, REF: PKA10001, and PKA10003
FDA Device · Class II · 2024-01-31 · Ossur H F
Other years
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