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.
- Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNT…
FDA Device · Class II · 2016-04-20 · Synthes Usa Products - Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healin…
FDA Device · Class II · 2016-04-20 · Customed - SurgiCounter scanner, part of the SurgiCount Safety-Sponge System
FDA Device · Class II · 2016-04-20 · Stryker Instruments Div - Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray…
FDA Device · Class II · 2016-04-20 · Philips Medical Systems Cleveland - Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such a…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical procedures and patient care procedures such as wound heali…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healin…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical pr…
FDA Device · Class II · 2016-04-20 · Customed - SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNT…
FDA Device · Class II · 2016-04-20 · Synthes Usa Products - Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - QUADROX-i oxygenators Custom tubing packs for the oxygenator
FDA Device · Class II · 2016-04-20 · Maquet Cardiovascular Us Sales - Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNT…
FDA Device · Class II · 2016-04-20 · Synthes Usa Products - Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X…
FDA Device · Class II · 2016-04-20 · Philips Medical Systems Cleveland - Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone c…
FDA Device · Class II · 2016-04-20 · Stryker Instruments Div - Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Rev…
FDA Device · Class II · 2016-04-20 · Synthes Usa Products - Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2016-04-20 · Customed - Arthrex Deltoid Ligament Reconstruction Implant System
FDA Device · Class II · 2016-04-20 · Arthrex - BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model)
FDA Device · Class II · 2016-04-20 · C R Bard - Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
FDA Device · Class II · 2016-04-20 · Maquet Cardiovascular Us Sales - Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only
FDA Device · Class II · 2016-04-20 · C R Bard - VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance…
FDA Device · Class II · 2016-04-20 · Alcon Research - Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound h…
FDA Device · Class II · 2016-04-20 · Customed - Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe an…
FDA Device · Class II · 2016-04-20 · Icu Medical - Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - BD-Retic-Count Reticulocyte Reagent System
FDA Device · Class III · 2016-04-20 · Becton Dickinson And Bd Biosciences - Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound he…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedu…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and…
FDA Device · Class II · 2016-04-20 · Customed - da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory
FDA Device · Class II · 2016-04-20 · Intuitive Surgical - Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wou…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Medix NatalCare ST-LX Intensive Care Incubator
FDA Device · Class II · 2016-04-20 · Natus Medical - SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNT…
FDA Device · Class II · 2016-04-20 · Synthes Usa Products - Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - GE Healthcare, Aisys Carestation
FDA Device · Class II · 2016-04-20 · Ge Medical Systems - Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray…
FDA Device · Class II · 2016-04-20 · Philips Medical Systems Cleveland - Custom Tubing Packs Custom tubing pack for oxygenators
FDA Device · Class II · 2016-04-20 · Maquet Cardiovascular Us Sales - Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and…
FDA Device · Class II · 2016-04-20 · Customed - BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter
FDA Device · Class II · 2016-04-20 · C R Bard - GE Healthcare, Aisys CS2 anesthesia
FDA Device · Class II · 2016-04-20 · Ge Medical Systems - Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound heal…
FDA Device · Class II · 2016-04-20 · Customed - NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000
FDA Device · Class II · 2016-04-13 · Northeast Laboratory Services - TOPAZ MicroDebrider 0.8 mm REF AC4040-01
FDA Device · Class II · 2016-04-13 · Arthrocare - Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452,…
FDA Device · Class II · 2016-04-13 · Focus Diagnostics - Ellex Medical Fixed eye Safety filters Model Integre S LP5532
FDA Device · Class II · 2016-04-13 · Laserex Systems - Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile
FDA Device · Class II · 2016-04-13 · Zimmer Manufacturing B V - NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box o…
FDA Device · Class II · 2016-04-13 · Angiodynamics - Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Deli…
FDA Device · Class II · 2016-04-13 · Fresenius Medical Care Renal Therapies Group - NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000
FDA Device · Class II · 2016-04-13 · Northeast Laboratory Services - VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110
FDA Device · Class II · 2016-04-13 · Ortho Clinical Diagnostics - TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature
FDA Device · Class II · 2016-04-13 · Scottcare - NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This need…
FDA Device · Class II · 2016-04-13 · Angiodynamics - All instrumentation associated with the Prelude PF Resurfacing Knee System
FDA Device · Class II · 2016-04-13 · Biomet - NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This…
FDA Device · Class II · 2016-04-13 · Angiodynamics - Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant
FDA Device · Class II · 2016-04-13 · Cardinal Health - eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimul…
FDA Device · Class II · 2016-04-13 · Philips Electronics North America - ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number:…
FDA Device · Class II · 2016-04-13 · Karl Storz Endovision - A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive…
FDA Device · Class II · 2016-04-13 · Siemens Medical Solutions Usa - CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structu…
FDA Device · Class II · 2016-04-13 · Applied Medical Resources - Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty
FDA Device · Class II · 2016-04-13 · Zimmer Manufacturing B V - MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
FDA Device · Class II · 2016-04-13 · Microaire Surgical Instruments - evaluemed Infant Heel Warmer 301-1223
FDA Device · Class II · 2016-04-13 · Philips Electronics North America - Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452,…
FDA Device · Class I · 2016-04-13 · Focus Diagnostics - Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use
FDA Device · Class III · 2016-04-13 · Richard Allan Scientific - STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular struct…
FDA Device · Class II · 2016-04-13 · Applied Medical Resources - Guardian II Hemostasis Valve, models 8210 and 8211
FDA Device · Class I · 2016-04-13 · Vascular Solutions - The THERAKOS CELLEX Photopheresis System is a photoimmune therapy
FDA Device · Class II · 2016-04-13 · Therakos - STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures…
FDA Device · Class II · 2016-04-13 · Applied Medical Resources - Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System i…
FDA Device · Class II · 2016-04-13 · Synthes Usa Products - GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control
FDA Device · Class II · 2016-04-13 · Ge Inspection Technologies - MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
FDA Device · Class II · 2016-04-13 · Microaire Surgical Instruments - Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
FDA Device · Class II · 2016-04-13 · Fresenius Medical Care Renal Therapies Group - Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System i…
FDA Device · Class II · 2016-04-13 · Synthes Usa Products - Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL14…
FDA Device · Class I · 2016-04-13 · Focus Diagnostics - SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, h…
FDA Device · Class II · 2016-04-13 · Ge Medical Systems - STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structu…
FDA Device · Class II · 2016-04-13 · Applied Medical Resources - NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This…
FDA Device · Class II · 2016-04-13 · Angiodynamics - Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debri…
FDA Device · Class II · 2016-04-06 · Ossur H F - Cios Alpha, mobile X-ray system
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL…
FDA Device · Class II · 2016-04-06 · Icu Medical - Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and…
FDA Device · Class II · 2016-04-06 · Wfr Aquaplast
Other years
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