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.
- AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide
FDA Device · Class II · 2015-08-19 · Boston Scientific - Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems - GE Optional Laser Centering Device X-ray generator
FDA Device · Class II · 2015-08-19 · Ge Inspection Technologies - PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap
FDA Device · Class II · 2015-08-19 · Remel - Celsite Implantable Access Port System, model ST301
FDA Device · Class II · 2015-08-19 · B Braun Interventional Systems - AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide
FDA Device · Class II · 2015-08-19 · Boston Scientific - Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems - PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software
FDA Device · Class II · 2015-08-19 · Biotronik - Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333…
FDA Device · Class II · 2015-08-19 · Invacare - Triathlon PS X3 Tibial Insert
FDA Device · Class II · 2015-08-19 · Stryker Howmedica Osteonics - AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized
FDA Device · Class II · 2015-08-19 · Boston Scientific - PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit
FDA Device · Class II · 2015-08-19 · Remel - Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems - Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
FDA Device · Class II · 2015-08-19 · Fresenius Medical Care Holdings - AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide
FDA Device · Class II · 2015-08-19 · Boston Scientific - Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems - Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hy…
FDA Device · Class II · 2015-08-19 · Etac Supply Center Ab - Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to pr…
FDA Device · Class II · 2015-08-19 · Hitachi Medical Systems America - ReSTOR intraocular lens and ReSTOR Toric intraocular lens
FDA Device · Class I · 2015-08-19 · Alcon Research - Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems - ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818
FDA Device · Class II · 2015-08-19 · Stryker Howmedica Osteonics - 8.5mm Reamer Head for Flexible Intramedullary Nailing System
FDA Device · Class II · 2015-08-19 · Synthes Usa Products - i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch
FDA Device · Class II · 2015-08-19 · Abbott Point - Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
FDA Device · Class II · 2015-08-19 · Cadence - Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209
FDA Device · Class II · 2015-08-19 · Cadence - Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit
FDA Device · Class II · 2015-08-12 · Medtronic Navigation - Beacon Tip Torcon NB Advantage Catheter
FDA Device · Class I · 2015-08-12 · Cook - Biograph mCT Flow Edge-4R, Model Number 10528955
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide…
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - Biograph mCT S(64)-4R, Model Number 10248672
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - Slip-Cath Beacon Tip Catheter
FDA Device · Class I · 2015-08-12 · Cook - EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for…
FDA Device · Class I · 2015-08-12 · Medtronic Cardiovascular Surgery The Heart Valve Division - Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant
FDA Device · Class II · 2015-08-12 · Titan Spine - Biograph mCT X-4R, Model Number 10248670
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer
FDA Device · Class II · 2015-08-12 · Roche Diagnostics Operations - Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module
FDA Device · Class II · 2015-08-12 · Merge Healthcare - Siemens Artis zee systems
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc
FDA Device · Class II · 2015-08-12 · Zimmer Surgical - Beacon Tip Royal Flush Plus High-Flow Catheter
FDA Device · Class I · 2015-08-12 · Cook - Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit
FDA Device · Class II · 2015-08-12 · Medtronic Navigation - Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool
FDA Device · Class II · 2015-08-12 · The Anspach Effort - 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc
FDA Device · Class II · 2015-08-12 · Zimmer Surgical - GE Healthcare, Signa Infinity MR System
FDA Device · Class II · 2015-08-12 · Ge Healthcare - SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - S4C Occiput Torque Wrench F/Set Screw
FDA Device · Class II · 2015-08-12 · Aesculap - Olympus Scientific Solutions Americas Analytical X-ray System
FDA Device · Class II · 2015-08-12 · Olympus Scientific Solutions Americas - Biograph mCT S(40)-4R, Model Number 10248671
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
FDA Device · Class II · 2015-08-12 · Atrium Medical - Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ…
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - Artis Q systems
FDA Device · Class II · 2015-08-12 · Siemens Medical Solutions Usa - Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medic…
FDA Device · Class II · 2015-08-12 · Philips Electronics North America - Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - ANSPACH - 7MM Extra Coarse Diamond Ball
FDA Device · Class II · 2015-08-05 · The Anspach Effort - ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure
FDA Device · Class II · 2015-08-05 · The Anspach Effort - ANSPACH - Fluted Drum, Side Cut Only
FDA Device · Class II · 2015-08-05 · The Anspach Effort - IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only
FDA Device · Class II · 2015-08-05 · Ivoclar Vivadent - Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM
FDA Device · Class II · 2015-08-05 · The Anspach Effort - ANSPACH - 6MM x 11.3MM Fluted Barrel
FDA Device · Class II · 2015-08-05 · The Anspach Effort - Prism Medical P-600 Portable Ceiling Lift
FDA Device · Class II · 2015-08-05 · Ergosafe Products Dba Prism Medical - ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium
FDA Device · Class II · 2015-08-05 · The Anspach Effort - ANSPACH - 4MM Diamond Ball, Extends 27MM
FDA Device · Class II · 2015-08-05 · The Anspach Effort - Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology
FDA Device · Class II · 2015-08-05 · Philips Medical Systems Cleveland - OxiMax N-65 Handheld Pulse Oximeter
FDA Device · Class II · 2015-08-05 · Covidien Formerly Nellcor Puritan Bennett - ANSPACH - Extra Coarse Diamond Ball
FDA Device · Class II · 2015-08-05 · The Anspach Effort - ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM
FDA Device · Class II · 2015-08-05 · The Anspach Effort - ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure
FDA Device · Class II · 2015-08-05 · The Anspach Effort - Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin A…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics - Medical Device Exchange - GelPort Laparoscopic System
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - Prism Medical P-440 Portable Ceiling Lift
FDA Device · Class II · 2015-08-05 · Ergosafe Products Dba Prism Medical - Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only
FDA Device · Class II · 2015-08-05 · Symmetry Surgical - Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium
FDA Device · Class II · 2015-08-05 · The Anspach Effort - ANSPACH - 8MM x 12.5MM Fluted Barrel
FDA Device · Class II · 2015-08-05 · The Anspach Effort - Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R…
FDA Device · Class II · 2015-08-05 · Synthes Usa Products - Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) A…
FDA Device · Class II · 2015-08-05 · Hardy Diagnostics - ANSPACH - Fluted Barrel
FDA Device · Class II · 2015-08-05 · The Anspach Effort - Medical Device Exchange - Mayfield Disposable Skull Pin
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - Medical Device Exchange Aerosizer Stent Sizing Device
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium
FDA Device · Class II · 2015-08-05 · The Anspach Effort - Computed Tomography X-ray Systems Ingenuity CT scanners
FDA Device · Class II · 2015-08-05 · Philips Medical Systems Cleveland - Medical Device Exchange -Suction Coagulator
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure
FDA Device · Class II · 2015-08-05 · The Anspach Effort - Computed Tomography X-ray Systems Ingenuity Core
FDA Device · Class II · 2015-08-05 · Philips Medical Systems Cleveland - ANSPACH - 5MM Fluted Ball, Extends 27MM
FDA Device · Class II · 2015-08-05 · The Anspach Effort - Computed Tomography X-ray Systems Ingenuity Core 128
FDA Device · Class II · 2015-08-05 · Philips Medical Systems Cleveland - Fabius MRI Anesthesia Machine
FDA Device · Class II · 2015-08-05 · Draeger Medical - Medical Device Exchange -APPLIER, MULTICLIP ROTATING
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic f…
FDA Device · Class II · 2015-08-05 · Otto Bock Healthcare - Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option
FDA Device · Class II · 2015-08-05 · Siemens Medical Solutions Usa - Medical Device Exchange - Endo Catch 10mm
FDA Device · Class II · 2015-08-05 · Exp Pharmaceutical Services - ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure
FDA Device · Class II · 2015-08-05 · The Anspach Effort
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)