FDA Device · 2025
FDA Device recalls in 2025
RecallRadar indexes 2,908 FDA Device recall notices published in 2025. By classification: 380 Class I, 2,433 Class II, 95 Class III.
- GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile
FDA Device · Class II · 2025-01-22 · Cook Biotech - Impella RP Flex with SmartAssist
FDA Device · Class I · 2025-01-22 · Abiomed - ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A
FDA Device · Class II · 2025-01-22 · Sklar Instruments - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960
FDA Device · Class II · 2025-01-22 · Sklar Instruments - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD
FDA Device · Class II · 2025-01-22 · Hologic - Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D deli…
FDA Device · Class II · 2025-01-22 · Alcon Research - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A
FDA Device · Class II · 2025-01-22 · Sklar Instruments - 8MM,MEGA SUTURECUT ND,IS4000 REF 471309
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M
FDA Device · Class II · 2025-01-22 · Sklar Instruments - BD Pyxis MedStation ES (Med ES Main), REF: 323
FDA Device · Class II · 2025-01-22 · Carefusion 303 - Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM
FDA Device · Class II · 2025-01-22 · Ev3 - Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT,…
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - muRata Vios Monitoring System Model 2050
FDA Device · Class II · 2025-01-22 · Murata Vios - 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01
FDA Device · Class II · 2025-01-22 · Isotis Orthobiologics - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - Impella RP with SmartAssist
FDA Device · Class I · 2025-01-22 · Abiomed - Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069
FDA Device · Class I · 2025-01-22 · Medline Industries Northfield - 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube
FDA Device · Class I · 2025-01-22 · Trokamed - ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
FDA Device · Class I · 2025-01-22 · Boston Scientific - DRG:HYBRiD-XL Insulin
FDA Device · Class II · 2025-01-22 · Drg International - Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
FDA Device · Class II · 2025-01-22 · Karl Storz Endoscopy - ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpo…
FDA Device · Class II · 2025-01-22 · Sklar Instruments - 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: N…
FDA Device · Class II · 2025-01-22 · Quidel Ortho - PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MR…
FDA Device · Class I · 2025-01-22 · Boston Scientific - 8MM, POTTS SCISSORS, IS4000 REF 470001
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedur…
FDA Device · Class II · 2025-01-22 · Sklar Instruments - 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630
FDA Device · Class II · 2025-01-22 · Sklar Instruments - ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution…
FDA Device · Class II · 2025-01-22 · Ge Medical Systems - 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedur…
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A
FDA Device · Class II · 2025-01-22 · Sklar Instruments - GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
FDA Device · Class I · 2025-01-22 · Boston Scientific - ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
FDA Device · Class II · 2025-01-22 · Sklar Instruments - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A
FDA Device · Class II · 2025-01-22 · Sklar Instruments - 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
FDA Device · Class II · 2025-01-22 · Accriva Diagnostics - Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527
FDA Device · Class I · 2025-01-22 · Medline Industries Northfield - ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier…
FDA Device · Class II · 2025-01-22 · Convatec - Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124,…
FDA Device · Class II · 2025-01-22 · Coloplast Manufacturing Us - Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile
FDA Device · Class II · 2025-01-22 · Cook Biotech - 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320
FDA Device · Class II · 2025-01-22 · Sklar Instruments - ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type)
FDA Device · Class I · 2025-01-22 · Olympus - Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923
FDA Device · Class II · 2025-01-22 · Sklar Instruments - 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - Change Healthcare Cardiology Hemodynamics software
FDA Device · Class II · 2025-01-22 · A L I Technologies - GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA Device · Class I · 2025-01-22 · Baxter Healthcare - 8MM,FORCE BIPOLAR,IS4000 REF 471405
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
FDA Device · Class I · 2025-01-22 · Boston Scientific - 8MM,COBRA GRASPER,IS4000 REF 471190
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - Augustine Surgical Inc
FDA Device · Class II · 2025-01-22 · Augustine Temperature Management - McKesson Cardiology Hemo software
FDA Device · Class II · 2025-01-22 · A L I Technologies - Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA Device · Class I · 2025-01-22 · Baxter Healthcare - Idylla INSTRUMENT, IVD, REF P0010
FDA Device · Class II · 2025-01-22 · Biocartis Nv - 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
FDA Device · Class II · 2025-01-22 · Sklar Instruments - GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243
FDA Device · Class II · 2025-01-22 · Sklar Instruments - 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
FDA Device · Class I · 2025-01-22 · Baxter Healthcare - GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF
FDA Device · Class II · 2025-01-22 · Ge Medical Systems Israel Functional Imaging - ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
FDA Device · Class I · 2025-01-22 · Boston Scientific - Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #
FDA Device · Class II · 2025-01-22 · Cardinal Health 200 - ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603
FDA Device · Class II · 2025-01-22 · Sklar Instruments - Augustine Surgical Inc
FDA Device · Class II · 2025-01-22 · Augustine Temperature Management - Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube
FDA Device · Class I · 2025-01-22 · Trokamed - 8MM,LONG TIP FORCEPS,IS4000 REF 471048
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - 8MM,FORCE BIPOLAR,IS4000 REF 470405
FDA Device · Class II · 2025-01-22 · Intuitive Surgical - GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3
FDA Device · Class II · 2025-01-15 · Ge Medical Systems
Other years
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