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.
- Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee…
FDA Device · Class II · 2016-01-13 · Corflex - Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
FDA Device · Class II · 2016-01-13 · Philips Ultrasound - BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorati…
FDA Device · Class II · 2016-01-13 · Biomet 3i - NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch
FDA Device · Class III · 2016-01-13 · Nipro Medical - HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the kne…
FDA Device · Class II · 2016-01-13 · Corflex - BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155,…
FDA Device · Class II · 2016-01-13 · Biomet 3i - Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to c…
FDA Device · Class II · 2016-01-13 · Maquet Cardiovascular Us Sales - Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8…
FDA Device · Class II · 2016-01-13 · Boston Scientific - Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Co…
FDA Device · Class II · 2016-01-13 · Benlan - SYNTHES
FDA Device · Class II · 2016-01-13 · Synthes Usa Products - BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR…
FDA Device · Class II · 2016-01-13 · Smith And Nephew - BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at th…
FDA Device · Class II · 2016-01-13 · Corflex - Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTp…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the kne…
FDA Device · Class II · 2016-01-13 · Corflex - Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyze…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee jo…
FDA Device · Class II · 2016-01-13 · Corflex - BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use…
FDA Device · Class II · 2016-01-13 · Biomet 3i - Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG meth…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc
FDA Device · Class II · 2016-01-13 · Ethicon - Natus Quantum System with NeuroWorks Software
FDA Device · Class II · 2016-01-13 · Natus Neurology - The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access…
FDA Device · Class I · 2016-01-13 · Stryker Sustainability Solutions - AMSCO¿ Warming Cabinet
FDA Device · Class II · 2016-01-13 · Steris - Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERI…
FDA Device · Class II · 2016-01-13 · Smith And Nephew - Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an a…
FDA Device · Class II · 2016-01-13 · Biomet 3i - Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimi…
FDA Device · Class II · 2016-01-06 · Beckman Coulter - Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women…
FDA Device · Class II · 2016-01-06 · Biomerieux - BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made…
FDA Device · Class II · 2016-01-06 · Becton Dickinson And - MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
FDA Device · Class II · 2016-01-06 · Elekta - BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD,…
FDA Device · Class II · 2016-01-06 · Becton Dickinson And - Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic…
FDA Device · Class II · 2016-01-06 · Merge Healthcare - Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
FDA Device · Class II · 2016-01-06 · Trumpf Medical Systems - MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimi…
FDA Device · Class II · 2016-01-06 · Beckman Coulter - BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Mad…
FDA Device · Class II · 2016-01-06 · Becton Dickinson And - Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery
FDA Device · Class II · 2016-01-06 · Aesculap - BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Mad…
FDA Device · Class II · 2016-01-06 · Becton Dickinson And - MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial age…
FDA Device · Class II · 2016-01-06 · Beckman Coulter - MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial age…
FDA Device · Class II · 2016-01-06 · Beckman Coulter - RenovoCath RC 120
FDA Device · Class II · 2016-01-06 · Renovorx - BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD,…
FDA Device · Class II · 2016-01-06 · Becton Dickinson And - Merge Cardio with software version 10.1 LA
FDA Device · Class II · 2016-01-06 · Merge Healthcare - Radiographic Transparency for Certain and External Connection Tapered Implants
FDA Device · Class II · 2016-01-06 · Biomet 3i - MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial age…
FDA Device · Class II · 2016-01-06 · Beckman Coulter
Other years
2026 (2,088) · 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)