FDA Device · 2015

FDA Device recalls in 2015

RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.

• ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Aequalis Humeral Nail Targeting Jig, Product Code: 9020060
  FDA Device · Class II · 2015-08-05 · Tornier
• Medical Device Exchange 10x40 Airway Stent System
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth wit…
  FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
• ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002
  FDA Device · Class II · 2015-08-05 · Hamilton Medical
• Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Bro…
  FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
• Paragon Laboratory Management
  FDA Device · Class II · 2015-08-05 · Mckesson Technologies
• InjectionPlasty 1.0 Bone Void Filler
  FDA Device · Class II · 2015-08-05 · Skeletal Kinetics
• Medical Device Exchange 3.5mm Threaded Cerclage Pin
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange - Silicone Round Drain
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange FEMORAL CANAL TIP
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange FIBERWIRE SUTURE SCISSOR
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange Wire (sternotomy wire)
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• ANSPACH - Fluted Ball
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange Round Fluted Bur Aggressive
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange 12x40 Airway Stent System
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange X-SAW BLADE
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• OxySure Model 615 disposable replacement cartridges, for portable oxygen generator
  FDA Device · Class II · 2015-08-05 · Oxysure Systems
• ANSPACH - 5MM x 11.3MM Fluted Barrel
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• ANSPACH - 4MM Fluted Ball, Extends 27MM
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X…
  FDA Device · Class II · 2015-08-05 · Philips Medical Systems Cleveland
• Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quan…
  FDA Device · Class III · 2015-08-05 · Acon Laboratories
• ANSPACH - 7MM Fluted Acorn
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange Round Fluted Bur Soft Touch
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey…
  FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
• FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
  FDA Device · Class II · 2015-08-05 · Encore Medical
• MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511
  FDA Device · Class II · 2015-08-05 · Medtronic Minimed
• OxiMax N-560 Pulse Oximeter
  FDA Device · Class II · 2015-08-05 · Covidien Formerly Nellcor Puritan Bennett
• ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 1044001…
  FDA Device · Class II · 2015-08-05 · Siemens Medical Solutions Usa
• ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange Round Diamond Bur Extra Coarse
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange 12MM VASCULAR
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange - Trocar VersaPort Plus V2
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin…
  FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
• ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange PT WIRE 300
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• ANSPACH -4MM Carbide Fluted Ball, Extends 27MM
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System
  FDA Device · Class II · 2015-08-05 · Philips Medical Systems Cleveland
• ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange -SYSTEM, TACKER SKIN 5MM
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Invivo Expression MRI Patient Monitoring System
  FDA Device · Class II · 2015-08-05 · Philips Electronics North America
• Medical Device Exchange Insufflation Needle
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Medical Device Exchange 10MM VASCULAR
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature
  FDA Device · Class II · 2015-08-05 · Musculoskeletal Transplant Foundation
• ANSPACH - Fluted Drum, Side Cut Only
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• ANSPACH - Fluted Barrel
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure
  FDA Device · Class II · 2015-08-05 · The Anspach Effort
• Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm
  FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services
• Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for t…
  FDA Device · Class II · 2015-08-05 · Hardy Diagnostics
• The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular De…
  FDA Device · Class II · 2015-07-29 · Ekos
• GEMINI GXL 16 Slice CT/PET System
  FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland
• Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package
  FDA Device · Class I · 2015-07-29 · Western Scott Fetzer
• Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsu…
  FDA Device · Class II · 2015-07-29 · Bausch And Lomb Surgical
• Tool, StripperW/BLD, 10S, Nonautoclavable
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a p…
  FDA Device · Class II · 2015-07-29 · Hitachi America Power Systems Division
• WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard¿" gamma counter is intended to detect and count gamma radiati…
  FDA Device · Class II · 2015-07-29 · Perkinelmer
• Fiber Stripper, 200¿m, Autoclavable
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• GEMINI TF 64 Slice CT/PET System
  FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland
• Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T…
  FDA Device · Class II · 2015-07-29 · Covidien
• Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System
  FDA Device · Class II · 2015-07-29 · Maquet Cardiovascular Us Sales
• Tool, Stripper W/BLD, 44S, Nonautoclavable
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endo…
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• GE Healthcare, Precision MPi fluoroscopic imaging systems
  FDA Device · Class II · 2015-07-29 · Ge Healthcare
• Fiber Stripper, 150¿m, Autoclavable
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSE…
  FDA Device · Class II · 2015-07-29 · Covidien
• ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only
  FDA Device · Class II · 2015-07-29 · Abbott Laboratories
• Tool, Stripper W/BLD, 28S, Nonautoclavable
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endo…
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only
  FDA Device · Class II · 2015-07-29 · Mermaid Medical A S
• THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator
  FDA Device · Class II · 2015-07-29 · Gardner Denver Thomas
• Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and count…
  FDA Device · Class II · 2015-07-29 · Perkinelmer
• GEMINI TF Big Bore CT/PET System
  FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland
• Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma radia…
  FDA Device · Class II · 2015-07-29 · Perkinelmer
• 1X1 Cleaving Tiles
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• Natrelle CUI Series Tissue Expanders
  FDA Device · Class II · 2015-07-29 · Allergan
• ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim c…
  FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics
• Bausch & Lomb SofPort Advanced Optics Aspheric Lens
  FDA Device · Class II · 2015-07-29 · Bausch And Lomb Surgical
• GEMINI LXL CT/PET System
  FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland
• Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems
  FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland
• Tool, Stripper W/BLD, 12S, Nonautoclavable
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• Tool, StripperW/BLD, 10S, Autoclavable
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation,…
  FDA Device · Class II · 2015-07-29 · Arthrocare
• Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
  FDA Device · Class II · 2015-07-29 · Volcano
• 365¿M Lithotripsy Fiber- Reusable
  FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley
• THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator
  FDA Device · Class II · 2015-07-29 · Gardner Denver Thomas

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)