FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-…
FDA Device · Class I · 2019-09-18 · Allergan - Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usag…
FDA Device · Class I · 2019-09-18 · Allergan - XP-CR Tibial Tray - Interlok 63mm Item # 195269
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and B…
FDA Device · Class I · 2019-09-18 · Allergan - Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-2…
FDA Device · Class I · 2019-09-18 · Teleflex Medical - Vanguard XP Tibial Tray 73 mm Item # 195250
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Berchtold Chromophare F528 Surgical Lights
FDA Device · Class II · 2019-09-18 · Stryker Communications - XP-XP Tibial Tray - Interlok 73 mm Item # 195756
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
FDA Device · Class I · 2019-09-18 · Teleflex Medical - Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Trach…
FDA Device · Class I · 2019-09-18 · Teleflex Medical - AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
FDA Device · Class II · 2019-09-11 · Boston Scientific - Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels
FDA Device · Class II · 2019-09-11 · Integra Lifesciences - The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm
FDA Device · Class II · 2019-09-11 · Lemaitre Vascular - CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
FDA Device · Class II · 2019-09-11 · B Braun Medical - The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in h…
FDA Device · Class II · 2019-09-11 · Roche Diagnostics Operations - DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
FDA Device · Class II · 2019-09-11 · Coltene Whaledent Ag - BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
FDA Device · Class II · 2019-09-11 · Becton Dickinson And - Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems
FDA Device · Class II · 2019-09-11 · Getinge Us Sales - CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
FDA Device · Class II · 2019-09-11 · B Braun Medical - HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the m…
FDA Device · Class II · 2019-09-11 · Haag Streit Usa - Titan Gel Serum Protein Control: SPE Control Cat
FDA Device · Class II · 2019-09-11 · Helena Laboratories - HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the…
FDA Device · Class II · 2019-09-11 · Haag Streit Usa - Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
FDA Device · Class II · 2019-09-11 · Carefusion 303 - Norm-O-Temp model 111Z
FDA Device · Class II · 2019-09-11 · Cincinnati Sub Zero Products A Gentherm - Flexible Intubation Fiberscope, Model # 11301AB1
FDA Device · Class II · 2019-09-11 · Karl Storz Endoscopy - Norm-O-Temp model 111W
FDA Device · Class II · 2019-09-11 · Cincinnati Sub Zero Products A Gentherm - Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The…
FDA Device · Class II · 2019-09-11 · Alere San Diego - CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
FDA Device · Class II · 2019-09-11 · B Braun Medical - FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160
FDA Device · Class II · 2019-09-11 · B Braun Medical - HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through…
FDA Device · Class II · 2019-09-11 · Haag Streit Usa - SonarMed AirWave Monitor, Model Number M0001
FDA Device · Class II · 2019-09-11 · Sonarmed - ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115
FDA Device · Class II · 2019-09-11 · B Braun Medical - SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device
FDA Device · Class II · 2019-09-11 · Heidelberg Engineering - BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
FDA Device · Class II · 2019-09-11 · Becton Dickinson And - AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
FDA Device · Class II · 2019-09-11 · Angiodynamics - cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
FDA Device · Class II · 2019-09-11 · Roche Diagnostics Operations - OMNIlife science, Inc
FDA Device · Class II · 2019-09-11 · Omnilife Science - cobas c513 Analyzer
FDA Device · Class II · 2019-09-11 · Roche Diagnostics Operations - Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light Syst…
FDA Device · Class II · 2019-09-11 · Stryker Communications - ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
FDA Device · Class II · 2019-09-11 · B Braun Medical - CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
FDA Device · Class II · 2019-09-11 · B Braun Medical - syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000
FDA Device · Class II · 2019-09-11 · Siemens Medical Solutions Usa - CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
FDA Device · Class II · 2019-09-11 · B Braun Medical - Fujifilm FDR Go Plus mobile X-ray system
FDA Device · Class II · 2019-09-11 · Fujifilm Medical Systems U - CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
FDA Device · Class II · 2019-09-11 · B Braun Medical - OMNIlife science, Inc
FDA Device · Class II · 2019-09-11 · Omnilife Science - OMNIlife science, Inc
FDA Device · Class II · 2019-09-11 · Omnilife Science - Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c…
FDA Device · Class II · 2019-09-11 · Roche Diagnostics Operations - EyeBOX Model OCL 02
FDA Device · Class II · 2019-09-04 · Oculogica - Skull Anchor Bolts
FDA Device · Class II · 2019-09-04 · Ad Tech Medical Instrument - GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable de…
FDA Device · Class II · 2019-09-04 · Abbott And Kg - Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
FDA Device · Class II · 2019-09-04 · Ad Tech Medical Instrument - EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Elec…
FDA Device · Class II · 2019-09-04 · Ad Tech Medical Instrument - SOMATOM go.Top
FDA Device · Class II · 2019-09-04 · Siemens Medical Solutions Usa - Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
FDA Device · Class II · 2019-09-04 · Roche Diagnostics Operations - Monaco Radiation Treatment Planning System (RTP) System
FDA Device · Class II · 2019-09-04 · Elekta - GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - SOMATOM go.Top
FDA Device · Class II · 2019-09-04 · Siemens Medical Solutions Usa - EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, U…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - SOMATOM go.All
FDA Device · Class II · 2019-09-04 · Siemens Medical Solutions Usa - Quantum Pump Console
FDA Device · Class I · 2019-09-04 · Spectrum Medical - EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-fil…
FDA Device · Class II · 2019-09-04 · Coopersurgical - Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product…
FDA Device · Class II · 2019-09-04 · Agilent Technologies - GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
FDA Device · Class II · 2019-09-04 · Drg Instruments - Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - SOMATOM go.Now
FDA Device · Class II · 2019-09-04 · Siemens Medical Solutions Usa - EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
FDA Device · Class II · 2019-09-04 · Roche Diagnostics Operations - GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - SOMATOM go.Up
FDA Device · Class II · 2019-09-04 · Siemens Medical Solutions Usa - Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee bip…
FDA Device · Class II · 2019-09-04 · Siemens Medical Solutions Usa - 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
FDA Device · Class II · 2019-09-04 · Becton Dickinson And - FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
FDA Device · Class II · 2019-09-04 · Karl Storz Endoscopy - Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UD…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UD…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular
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)