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.
- Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Eye Plastic Tray, Kit number PSS1931(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 TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Uniq…
FDA Device · Class II · 2016-10-26 · Ortho Clinical Diagnostics - Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down…
FDA Device · Class II · 2016-10-26 · Zimmer Biomet - Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Endoscopic Articulating Linear Cutter, 38ATW35
FDA Device · Class II · 2016-10-26 · Ethicon Endo Surgery - Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of…
FDA Device · Class I · 2016-10-26 · Heartware - Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - CD79b PE (ASR) , Catalog number 335816
FDA Device · Class II · 2016-10-26 · Becton Dickinson And Bd Biosciences - Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital op…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating r…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating ro…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital op…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow…
FDA Device · Class I · 2016-10-26 · Teleflex Medical - Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
FDA Device · Class II · 2016-10-26 · Olympus - Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hosp…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Uniqu…
FDA Device · Class II · 2016-10-26 · Ortho Clinical Diagnostics - SDMS (SenTec Digital Monitoring System)
FDA Device · Class II · 2016-10-26 · Sentec Ag - Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Morris Hysto Pack, Kit number PSS3198 and PSS3198(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 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453…
FDA Device · Class II · 2016-10-26 · Philips Electronics North America - Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital oper…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for genera…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230
FDA Device · Class I · 2016-10-26 · Vascular Solutions - Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusio…
FDA Device · Class II · 2016-10-26 · Rti Surgical Dba Pioneer Surgical Technology - D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for genera…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, R…
FDA Device · Class II · 2016-10-26 · Ortho Clinical Diagnostics - Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210
FDA Device · Class I · 2016-10-26 · Vascular Solutions - Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended fo…
FDA Device · Class II · 2016-10-26 · Tearscience - Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum…
FDA Device · Class II · 2016-10-26 · Randox Laboratories - Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Calix P PEEK Lumbar System, PLIF Rasp
FDA Device · Class II · 2016-10-26 · X Spine Systems - General Plastics Pack, Kit number 008617-1 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 Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, C…
FDA Device · Class II · 2016-10-26 · Conmed - Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230
FDA Device · Class I · 2016-10-26 · Vascular Solutions - Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general sur…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating…
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid art…
FDA Device · Class II · 2016-10-26 · Zimmer Biomet - General Pack II, Kit number CMP1812(B 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)