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.
- BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404
FDA Device · Class II · 2024-02-14 · Angiodynamics - BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx
FDA Device · Class II · 2024-02-14 · Brasseler Usa I - Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
FDA Device · Class I · 2024-02-14 · Cardinal Health 200 - Flow-i C20 Anesthesia System, model 6677200
FDA Device · Class II · 2024-02-14 · Getinge Usa Sales - BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
FDA Device · Class I · 2024-02-14 · Cardinal Health 200 - Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340
FDA Device · Class II · 2024-02-14 · Philips Medical Systems - Neurovascular embolization device
FDA Device · Class II · 2024-02-14 · Balt Usa - ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
FDA Device · Class II · 2024-02-14 · Globus Medical - HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
FDA Device · Class II · 2024-02-14 · Howmedica Osteonics - BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
FDA Device · Class II · 2024-02-14 · Philips North America - BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGP…
FDA Device · Class II · 2024-02-14 · Globus Medical - BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
FDA Device · Class II · 2024-02-14 · Philips North America - BrightView X, gamma camera for SPECT
FDA Device · Class I · 2024-02-14 · Philips North America - BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - The Prestige Coil System is a product family of embolic coils with associated delivery system components
FDA Device · Class II · 2024-02-14 · Balt Usa - 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Commu…
FDA Device · Class I · 2024-02-14 · Thoratec - BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Flow-c Anesthesia System, model 6887700
FDA Device · Class II · 2024-02-14 · Getinge Usa Sales - Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
FDA Device · Class I · 2024-02-14 · Cardinal Health 200 - Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
FDA Device · Class I · 2024-02-14 · Cardinal Health 200 - BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Article No. NA6050411, Valiant PhD No. 1 Econo
FDA Device · Class II · 2024-02-14 · Ivoclar Vivadent - BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
FDA Device · Class II · 2024-02-14 · Olympus - BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior
FDA Device · Class II · 2024-02-14 · Beckman Coulter - Flow-e Anesthesia System, model 6887900
FDA Device · Class II · 2024-02-14 · Getinge Usa Sales - BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
FDA Device · Class II · 2024-02-14 · Biofire Diagnostics - Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
FDA Device · Class I · 2024-02-14 · Cardinal Health 200 - BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing
FDA Device · Class II · 2024-02-14 · Becton Dickinson And - Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
FDA Device · Class I · 2024-02-14 · Cardinal Health 200 - Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
FDA Device · Class I · 2024-02-14 · Cardinal Health 200 - Philips Azurion system, Interventional fluoroscopic x-ray system
FDA Device · Class II · 2024-02-07 · Philips Medical Systems Nederland B V - Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terra…
FDA Device · Class II · 2024-02-07 · Terragene - Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Intera Achieva 1.5T Pulsar
FDA Device · Class II · 2024-02-07 · Philips North America - Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA
FDA Device · Class II · 2024-02-07 · American Contract Systems - Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G
FDA Device · Class II · 2024-02-07 · American Contract Systems - PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
FDA Device · Class II · 2024-02-07 · Draegerwerk Ag And Kgaa - Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27
FDA Device · Class II · 2024-02-07 · American Contract Systems - Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C
FDA Device · Class II · 2024-02-07 · American Contract Systems - EVair air compressor, model numbers: M1230849 and M1230847
FDA Device · Class I · 2024-02-07 · Datex Ohmeda - PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
FDA Device · Class II · 2024-02-07 · Ge Healthcare Austria And - RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - smiths medical Medfusion Model 3500 Syringe pump
FDA Device · Class I · 2024-02-07 · Smiths Medical Asd - EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years)
FDA Device · Class II · 2024-02-07 · Olympus - MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
FDA Device · Class II · 2024-02-07 · Medline Industries Northfield - 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 - LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolesce…
FDA Device · Class II · 2024-02-07 · Olympus - SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L
FDA Device · Class II · 2024-02-07 · American Contract Systems - EZDilate Wire Guided Balloon 16-17-18
FDA Device · Class II · 2024-02-07 · Olympus - LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D
FDA Device · Class II · 2024-02-07 · American Contract Systems - SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296
FDA Device · Class II · 2024-02-07 · Philips North America - SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 y…
FDA Device · Class II · 2024-02-07 · Olympus - SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
FDA Device · Class II · 2024-02-07 · Medline Industries Northfield - Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J
FDA Device · Class II · 2024-02-07 · American Contract Systems - PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FDA Device · Class II · 2024-02-07 · Fx Shoulder - SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT…
FDA Device · Class II · 2024-02-07 · Covidien - EZDilate Fixed Wire Balloon 16-17-18
FDA Device · Class II · 2024-02-07 · Olympus - Intera 1.5T Achieva Nova-Dual
FDA Device · Class II · 2024-02-07 · Philips North America - SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Intera 1.5T Achieva Nova
FDA Device · Class II · 2024-02-07 · Philips North America - SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics - Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
FDA Device · Class II · 2024-02-07 · Howmedica Osteonics
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