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.
- AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient…
FDA Device · Class II · 2016-08-10 · Beckman Coulter - Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box
FDA Device · Class II · 2016-08-10 · Zimmer Surgical - Merge HEMO software
FDA Device · Class II · 2016-08-10 · Merge Healthcare - ONLINE TDM Vancomycin 100 tests
FDA Device · Class II · 2016-08-10 · Roche Diagnostics Operations - Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be…
FDA Device · Class II · 2016-08-03 · Ge Healthcare It - Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non steri…
FDA Device · Class II · 2016-08-03 · Draeger Medical - AUTOCOMP6 High Speed Compounder
FDA Device · Class II · 2016-08-03 · The Metrix - Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and s…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package
FDA Device · Class III · 2016-08-03 · Tosoh Bioscience - Endotine Transbleph 3.5 (CFD-080-0167)
FDA Device · Class II · 2016-08-03 · Microaire Surgical Instruments - Integra External Fixation System Rocker Bottom Model # 12225400
FDA Device · Class II · 2016-08-03 · Integra Lifesciences - Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
FDA Device · Class II · 2016-08-03 · The Metrix - AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular - ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline…
FDA Device · Class II · 2016-08-03 · Siemens Healthcare Diagnostics - AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular - UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300
FDA Device · Class II · 2016-08-03 · Beckman Coulter - VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD…
FDA Device · Class II · 2016-08-03 · Ortho Clinical Diagnostics - Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
FDA Device · Class II · 2016-08-03 · The Metrix - Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm
FDA Device · Class II · 2016-08-03 · Stryker Howmedica Osteonics - AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular - Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL
FDA Device · Class II · 2016-08-03 · The Metrix - Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract
FDA Device · Class II · 2016-08-03 · Pentax Medical - Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively a…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular - Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404
FDA Device · Class III · 2016-08-03 · Alere San Diego - Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract
FDA Device · Class II · 2016-08-03 · Pentax Medical - AUTOCOMP6 XP High Speed Compounder REF 58810
FDA Device · Class II · 2016-08-03 · The Metrix - Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative an…
FDA Device · Class II · 2016-08-03 · Siemens Healthcare Diagnostics - Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitativ…
FDA Device · Class III · 2016-08-03 · Alere San Diego - MOSAIQ Oncology Information System
FDA Device · Class II · 2016-08-03 · Elekta - DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971
FDA Device · Class I · 2016-08-03 · Carefusion 2200 - Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemente…
FDA Device · Class II · 2016-08-03 · Zimmer - SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated fo…
FDA Device · Class II · 2016-08-03 · Smith And Nephew - Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to…
FDA Device · Class II · 2016-08-03 · Pentax Medical - Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593
FDA Device · Class II · 2016-08-03 · Beckman Coulter - GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems
FDA Device · Class II · 2016-08-03 · Ge Inspection Technologies - Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to i…
FDA Device · Class II · 2016-08-03 · Best Theratronics - Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualit…
FDA Device · Class III · 2016-08-03 · Alere San Diego - AUTOCOMP6 XPS High Speed Compounder REF 58810
FDA Device · Class II · 2016-08-03 · The Metrix - Container fill and transfer sets, 250 mL and 500 mL, .
FDA Device · Class II · 2016-08-03 · The Metrix - Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitat…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift…
FDA Device · Class II · 2016-08-03 · Moller Vital - AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular - Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitative…
FDA Device · Class III · 2016-08-03 · Alere San Diego - Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip appli…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular - Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract
FDA Device · Class II · 2016-08-03 · Pentax Medical - Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract
FDA Device · Class II · 2016-08-03 · Pentax Medical - Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL
FDA Device · Class II · 2016-08-03 · The Metrix - Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract
FDA Device · Class II · 2016-08-03 · Pentax Medical - Quickie Q7 wheelchair
FDA Device · Class II · 2016-08-03 · Sunrise Medical Us - AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge c…
FDA Device · Class II · 2016-08-03 · Lemaitre Vascular - Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitativ…
FDA Device · Class II · 2016-07-27 · Csl Behring - The pump (with cushioning foam inserts) is packaged in a single pump box
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - T095-022, IV Set with 0.22 Micron Filter
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
FDA Device · Class I · 2016-07-27 · Stryker Sustainability Solutions - Sarns TCM
FDA Device · Class II · 2016-07-27 · Terumo Cardiovascular Systems - cobas¿ Liat¿ Analyzer
FDA Device · Class II · 2016-07-27 · Roche Molecular Systems - AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 042…
FDA Device · Class II · 2016-07-27 · Amd Ritmed - T090-000 90" 20 Drop IV Admin Set
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - T100-000VF, IV Set with Lower Y Site and Free Flow Clip
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - T095-120 IV Set with 1.2 Micron Filter
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - T100-000F, 100" IV Set with Free Flow Clip
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - T100-022F with 0.22 micron filter and FP Clip
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning Sy…
FDA Device · Class II · 2016-07-27 · Raysearch Laboratories Ab - Preamendments device-Sarns Dual Cooler-Heater
FDA Device · Class II · 2016-07-27 · Terumo Cardiovascular Systems - Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to b…
FDA Device · Class II · 2016-07-27 · Nobel Biocare Usa - 2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro
FDA Device · Class II · 2016-07-27 · Stryker Instruments Div - Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
FDA Device · Class II · 2016-07-27 · Toshiba American Medical Systems - Parker Trach-Vac Endotracheal Tubes
FDA Device · Class II · 2016-07-27 · Parker Medical - HX2" Temperature Management Systems
FDA Device · Class II · 2016-07-27 · Terumo Cardiovascular Systems - T100-120F with 1.2 micron filter and FP Clip
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - Spike Set, 12" Microbore SPM-12
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0…
FDA Device · Class II · 2016-07-27 · Siemens Healthcare Diagnostics - Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXp…
FDA Device · Class II · 2016-07-27 · Bayer Healthcare - Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Dia…
FDA Device · Class II · 2016-07-27 · Carestream Health - Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter
FDA Device · Class II · 2016-07-27 · Smith And Nephew - Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine
FDA Device · Class II · 2016-07-27 · The Anspach Effort - Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz
FDA Device · Class II · 2016-07-27 · Amerx Health Care - Syngo.via, picture archiving and communications system software controlled
FDA Device · Class II · 2016-07-27 · Siemens Medical Solutions Usa - T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood
FDA Device · Class II · 2016-07-27 · Becton Dickinson And Bd Biosciences - ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only
FDA Device · Class II · 2016-07-27 · Hologic - MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
FDA Device · Class II · 2016-07-27 · Encore Medical - T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use i…
FDA Device · Class II · 2016-07-27 · Biomet - Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASI…
FDA Device · Class II · 2016-07-27 · Centurion Medical Products - The pump (with cushioning foam inserts) is packaged in a single pump box
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 c…
FDA Device · Class II · 2016-07-27 · Roche Molecular Systems - T030-000 -30" 20 Drop IV Admin Secondary Set
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - OT1000 Series Orthopedic Surgical Tables
FDA Device · Class II · 2016-07-27 · Steris - The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer)
FDA Device · Class II · 2016-07-27 · Beckman Coulter - Sarns TCM II
FDA Device · Class II · 2016-07-27 · Terumo Cardiovascular Systems - T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip
FDA Device · Class II · 2016-07-27 · Walkmed Infusion - Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, C…
FDA Device · Class II · 2016-07-27 · Synthes Usa Products - DeVilbiss Model 7305P-D Powered Suction Unit
FDA Device · Class II · 2016-07-27 · Devilbiss Healthcare - 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fract…
FDA Device · Class II · 2016-07-20 · Synthes Usa Products - Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: Target Detachable Coils are intended to endova…
FDA Device · Class II · 2016-07-20 · Stryker Neurovascular
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