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.
- SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070:, REF SA6AL25. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities a…
FDA Device · Class II · 2019-10-09 · Voco - SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5, .070", REF SA6SCR35. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
FDA Device · Class II · 2019-10-09 · Paltop Advanced Dental Solutions - SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0 SH, 100CM, 070", REF SA6FL40SH. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM T…
FDA Device · Class II · 2019-10-02 · Arrow International - DigitalDiagnost C50, Stationary X-ray System
FDA Device · Class II · 2019-10-02 · Philips Healthcare - MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair…
FDA Device · Class II · 2019-10-02 · Medline Industries - Accu-Chek Connect Diabetes Management App
FDA Device · Class II · 2019-10-02 · Roche Diabetes Care - MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c…
FDA Device · Class II · 2019-10-02 · Sentinel Ch Spa - Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V…
FDA Device · Class II · 2019-10-02 · Smiths Medical Asd - Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control…
FDA Device · Class III · 2019-10-02 · Randox Laboratories - B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
FDA Device · Class I · 2019-10-02 · B Braun Medical - Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and t…
FDA Device · Class II · 2019-10-02 · Sentinel Ch Spa - Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti…
FDA Device · Class II · 2019-10-02 · Siemens Healthcare Diagnostics - The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine…
FDA Device · Class II · 2019-10-02 · Getinge Us Sales - Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for pati…
FDA Device · Class II · 2019-10-02 · Elekta - Proteus XR/a (SlOK : K993090)
FDA Device · Class II · 2019-10-02 · Ge Healthcare - V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro…
FDA Device · Class II · 2019-10-02 · Vital Scientific N V - Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Cat…
FDA Device · Class II · 2019-10-02 · Arrow International - APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product
FDA Device · Class II · 2019-10-02 · Abbott Laboratories - Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for pat…
FDA Device · Class II · 2019-10-02 · Elekta - Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
FDA Device · Class II · 2019-10-02 · Philips North America - Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue
FDA Device · Class II · 2019-10-02 · Gn Otometrics - QuickGraft¿ Model # 430PST
FDA Device · Class II · 2019-10-02 · Musculoskeletal Transplant Foundation - Hemospray Endoscopic Hemostat
FDA Device · Class II · 2019-09-25 · Wilson Cook Medical - LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures
FDA Device · Class III · 2019-09-25 · Coopersurgical - AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
FDA Device · Class II · 2019-09-25 · Ad Tech Medical Instrument - IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded tw…
FDA Device · Class II · 2019-09-25 · Philips North America - Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
FDA Device · Class II · 2019-09-25 · Boston Scientific - Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
FDA Device · Class II · 2019-09-25 · Maquet Cardiovascular Us Sales - Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Device · Class II · 2019-09-25 · Boston Scientific - Berchtold Chromophare F628 Surgical Lights
FDA Device · Class II · 2019-09-18 · Stryker Communications - XP-CR Tibial Tray - Interlok 65mm Item # 195270
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-XP Tibial Tray - Interlok 67 mm Item # 195753
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-CR Tibial Tray - Interlok 71mm Item # 195273
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Vanguard XP Tibial Tray 79 mm Item # 195252
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - ROTEM ex-tem Canada Part No: 503-05-CA
FDA Device · Class II · 2019-09-18 · Instrumentation Laboratory - Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-101…
FDA Device · Class I · 2019-09-18 · Teleflex Medical - XP-XP Tibial Tray - Interlok 63 mm Item # 195751
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-CR Tibial Tray - Interlok 79 mm Item # 195276
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Vanguard XP Tibial Tray 71 mm Item # 195249
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 1…
FDA Device · Class I · 2019-09-18 · Allergan - Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-…
FDA Device · Class I · 2019-09-18 · Teleflex Medical - XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Vanguard XP Tibial Tray 69 mm Item # 195248
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Vanguard XP Tibial Tray 67 mm Item # 195247
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-XP Tibial Tray - Interlok 83 mm Item # 195759
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast…
FDA Device · Class I · 2019-09-18 · Allergan - This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays
FDA Device · Class III · 2019-09-18 · Randox Laboratories - Vanguard XP Tibial Tray 83 mm Item # 195253
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-XP Tibial Tray - Interlok 65 mm Item # 195752
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-CR Tibial Tray - Interlok 73mm Item # 195274
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Vari…
FDA Device · Class I · 2019-09-18 · Allergan - Vanguard XP Tibial Tray 87 mm Item # 195254
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-CR Tibial Tray - Interlok 75mm Item # 195275
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedu…
FDA Device · Class II · 2019-09-18 · Aesculap Implant Systems - Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314…
FDA Device · Class I · 2019-09-18 · Teleflex Medical - CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedur…
FDA Device · Class II · 2019-09-18 · Aesculap Implant Systems - ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
FDA Device · Class II · 2019-09-18 · Instrumentation Laboratory - Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augm…
FDA Device · Class I · 2019-09-18 · Allergan - Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product U…
FDA Device · Class I · 2019-09-18 · Allergan - XP-XP Tibial Tray - Interlok 71 mm Item # 195755
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a co…
FDA Device · Class II · 2019-09-18 · Exactech - Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction
FDA Device · Class I · 2019-09-18 · Allergan - HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator,…
FDA Device · Class II · 2019-09-18 · Philips North America - Vanguard XP Tibial Tray 75 mm Item # 195251
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP- CR Tibial Tray- Interlok 59mm Item # 195268
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-…
FDA Device · Class I · 2019-09-18 · Allergan - XP-XP Tibial Tray - Interlok 87 mm Item # 195760
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside moni…
FDA Device · Class II · 2019-09-18 · Philips North America - XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-CR Tibial Tray - Interlok 87 mm Item # 195278
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-CR Tibial Tray - Interlok 83 mm Item # 195277
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-CR Tibial Tray - Interlok 91 mm Item # 195279
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction
FDA Device · Class I · 2019-09-18 · Allergan - XP-CR Tibial Tray - Interlok 69mm Item # 195272
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-XP Tibial Tray - Interlok 59 mm Item # 195750
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designe…
FDA Device · Class II · 2019-09-18 · Smith And Nephew - Vanguard XP Tibial Tray 65 mm Item # 195246
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE…
FDA Device · Class I · 2019-09-18 · Allergan - Medtronic Micra MC1VR01, REF MC1VR01 (OUS only)
FDA Device · Class II · 2019-09-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, i…
FDA Device · Class I · 2019-09-18 · Allergan - Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl…
FDA Device · Class II · 2019-09-18 · Zeus Scientific - Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only)
FDA Device · Class II · 2019-09-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
FDA Device · Class I · 2019-09-18 · Teleflex Medical - Vanguard XP Tibial Tray 63 mm Item # 195245
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - XP-XP Tibial Tray - Interlok 75 mm Item # 195757
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infus…
FDA Device · Class I · 2019-09-18 · Allergan - ROTEM ex-tem
FDA Device · Class II · 2019-09-18 · Instrumentation Laboratory - XP-XP Tibial Tray - Interlok 91mm Item # 195761
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108,…
FDA Device · Class I · 2019-09-18 · Teleflex Medical - XP-CR Tibial Tray - Interlok 67mm Item # 195271
FDA Device · Class II · 2019-09-18 · Zimmer Biomet - Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the follow…
FDA Device · Class I · 2019-09-18 · Allergan
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