FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
FDA Device · Class II · 2016-11-02 · Aesculap Implant Systems - Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis fo…
FDA Device · Class II · 2016-11-02 · Tz Medical - cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully aut…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, E…
FDA Device · Class II · 2016-11-02 · Pentax - Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and so…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US…
FDA Device · Class II · 2016-11-02 · Siemens Healthcare Diagnostics - ex-TEM Assay for ROTEM delta Thromboelastometry System
FDA Device · Class II · 2016-11-02 · Tem Systems - VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only
FDA Device · Class III · 2016-11-02 · Ortho Clinical Diagnostics - IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985…
FDA Device · Class II · 2016-11-02 · Siemens Healthcare Diagnostics - cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usa…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments
FDA Device · Class III · 2016-11-02 · Becton Dickinson And - VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a co…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Ty…
FDA Device · Class II · 2016-10-26 · Synergetics - Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Calix T PEEK Lumbar System, TLIF Trial
FDA Device · Class II · 2016-10-26 · X Spine Systems - Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operati…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340,…
FDA Device · Class II · 2016-10-26 · Ortho Clinical Diagnostics - Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564…
FDA Device · Class II · 2016-10-26 · Philips Electronics North America - CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84…
FDA Device · Class II · 2016-10-26 · Conmed - Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operati…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part:…
FDA Device · Class II · 2016-10-26 · Philips Electronics North America - Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barr…
FDA Device · Class II · 2016-10-26 · Synergetics - D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for ge…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The C…
FDA Device · Class II · 2016-10-26 · Conmed - Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Agee-WristJack¿ Fracture Reduction System
FDA Device · Class II · 2016-10-26 · Hand Biomechanics Lab - Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Fusion Workstation
FDA Device · Class II · 2016-10-26 · Merge Healthcare - CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparos…
FDA Device · Class II · 2016-10-26 · Conmed - Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (C…
FDA Device · Class II · 2016-10-26 · Conmed - Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - DND Pack, Kit number AMS3846 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital op…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital o…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used f…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital op…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related t…
FDA Device · Class II · 2016-10-26 · Stryker Instruments Div - Calix P PEEK Lumbar System, PLIF Trial
FDA Device · Class II · 2016-10-26 · X Spine Systems - Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital op…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be u…
FDA Device · Class II · 2016-10-26 · Us Endoscopy Group - C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Calix T PEEK Lumbar System, TLIF Rasp
FDA Device · Class II · 2016-10-26 · X Spine Systems - Plastic General Pack, Kit number AMS4215 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenie…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications…
FDA Device · Class II · 2016-10-26 · Conmed - Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting…
FDA Device · Class II · 2016-10-26 · Merge Healthcare - 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid s…
FDA Device · Class II · 2016-10-26 · Synergetics - 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration
FDA Device · Class II · 2016-10-26 · Synergetics - Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX,…
FDA Device · Class II · 2016-10-26 · Conmed - Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, a…
FDA Device · Class I · 2016-10-26 · Leonhard Lang Medizintechnik - Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Dr. Fetters Hand Pack, Kit number AMS3690 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - CADstream software
FDA Device · Class II · 2016-10-26 · Merge Healthcare - Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A,…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging
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)