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.
- Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transduc…
FDA Device · Class II · 2016-09-21 · Icu Medical - LAUREATE World Phaco System
FDA Device · Class II · 2016-09-21 · Alcon Research - Option-vf Urinary Catheter
FDA Device · Class II · 2016-09-21 · C R Bard - Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template…
FDA Device · Class II · 2016-09-21 · Integra Lifesciences - Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
FDA Device · Class II · 2016-09-21 · Siemens Healthcare Diagnostics - Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-426…
FDA Device · Class II · 2016-09-21 · Icu Medical - GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
FDA Device · Class II · 2016-09-21 · Allergy Laboratories - Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the Sapphir…
FDA Device · Class II · 2016-09-21 · Hospira A Pfizer - Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-…
FDA Device · Class II · 2016-09-21 · Icu Medical - Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usa…
FDA Device · Class II · 2016-09-21 · Icu Medical - Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mou…
FDA Device · Class II · 2016-09-21 · Icu Medical - Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal so…
FDA Device · Class II · 2016-09-21 · Stryker Howmedica Osteonics - Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055,…
FDA Device · Class II · 2016-09-21 · Siemens Healthcare Diagnostics - Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Ins…
FDA Device · Class II · 2016-09-21 · Stryker Howmedica Osteonics - RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
FDA Device · Class II · 2016-09-21 · Siemens Healthcare Diagnostics - RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
FDA Device · Class II · 2016-09-21 · Siemens Healthcare Diagnostics - SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an ext…
FDA Device · Class II · 2016-09-21 · Icu Medical - Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usag…
FDA Device · Class II · 2016-09-21 · Icu Medical - The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood co…
FDA Device · Class II · 2016-09-21 · Circulatory Technology - CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO…
FDA Device · Class II · 2016-09-21 · Biosense Webster - Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac…
FDA Device · Class II · 2016-09-21 · Icu Medical - Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
FDA Device · Class II · 2016-09-21 · Arrow International - Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT)…
FDA Device · Class II · 2016-09-21 · Icu Medical - Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Trans…
FDA Device · Class II · 2016-09-21 · Icu Medical - Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive…
FDA Device · Class II · 2016-09-21 · Siemens Medical Solutions Usa - Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
FDA Device · Class III · 2016-09-21 · Clark Laboratories Dba Trinity Biotech Usa - Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT)…
FDA Device · Class II · 2016-09-21 · Icu Medical - Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803,…
FDA Device · Class II · 2016-09-21 · Siemens Healthcare Diagnostics - Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposab…
FDA Device · Class II · 2016-09-21 · Icu Medical - Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either a…
FDA Device · Class II · 2016-09-21 · Stryker Howmedica Osteonics - Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters
FDA Device · Class II · 2016-09-21 · Arrow International - AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic para…
FDA Device · Class II · 2016-09-21 · Airstrip Technologies - Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, st…
FDA Device · Class II · 2016-09-21 · Siemens Medical Solutions Usa - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - GE Healthcare SIGNA Creator, SIGNA Explorer
FDA Device · Class II · 2016-09-14 · Ge Healthcare - Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated car…
FDA Device · Class II · 2016-09-14 · Hill Rom - Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of he…
FDA Device · Class II · 2016-09-14 · Innovision A S - ArjoHuntleigh Sara Combilizer
FDA Device · Class II · 2016-09-14 · Arjohuntleigh Polska Sp Z O O - BrightView XCT Upgrade Model 882454
FDA Device · Class II · 2016-09-14 · Philips Medical Systems Cleveland - Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is inten…
FDA Device · Class II · 2016-09-14 · Novadaq Technologies - Merge RadSuite software
FDA Device · Class II · 2016-09-14 · Merge Healthcare - ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) hold…
FDA Device · Class II · 2016-09-14 · Advanced Medical Solutions - Plum A+ Infusion Pump with Hospira MedNet Software
FDA Device · Class II · 2016-09-14 · Hospira - Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consi…
FDA Device · Class II · 2016-09-14 · Sorin Group Usa - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - ADVIA Centaur¿ PSA Assay
FDA Device · Class II · 2016-09-14 · Siemens Healthcare Diagnostics - UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System
FDA Device · Class II · 2016-09-14 · Beckman Coulter - Plum A+3 Infusion Pump System
FDA Device · Class II · 2016-09-14 · Hospira - WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111,…
FDA Device · Class II · 2016-09-14 · Teleflex Medical - Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, It…
FDA Device · Class II · 2016-09-14 · Ecolab - Plum A+ Infusion Pump
FDA Device · Class II · 2016-09-14 · Hospira - Neural Signal Amplifier
FDA Device · Class II · 2016-09-14 · Blackrock Microsystems - BrightView X, model #882478
FDA Device · Class II · 2016-09-14 · Philips Medical Systems Cleveland - Patient Cable
FDA Device · Class II · 2016-09-14 · Blackrock Microsystems - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation
FDA Device · Class II · 2016-09-14 · Arrow International - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - NOMAD Pro Packaged X-Ray System, Part Number 08500009
FDA Device · Class II · 2016-09-14 · Aribex - The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet…
FDA Device · Class II · 2016-09-14 · Invivo - e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using…
FDA Device · Class II · 2016-09-14 · Siemens Medical Solutions Usa - MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for bre…
FDA Device · Class II · 2016-09-14 · Mentor Texas - Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth
FDA Device · Class II · 2016-09-14 · Anthogyr - PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marke…
FDA Device · Class II · 2016-09-14 · Terumo Medical - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for AT…
FDA Device · Class II · 2016-09-14 · Hologic - Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vesse…
FDA Device · Class II · 2016-09-14 · Arrow International - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - Plum A+3 Infusion Pump
FDA Device · Class II · 2016-09-14 · Hospira - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
FDA Device · Class II · 2016-09-14 · Philips Medical Systems Cleveland - NOMAD Pro2 Packaged X-Ray System, Part Number 08500021
FDA Device · Class II · 2016-09-14 · Aribex - Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture
FDA Device · Class II · 2016-09-14 · Smith And Nephew - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for bre…
FDA Device · Class II · 2016-09-14 · Mentor Texas - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6)
FDA Device · Class II · 2016-09-14 · Sorin Group Usa - ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packagin…
FDA Device · Class II · 2016-09-14 · Advanced Medical Solutions - Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only
FDA Device · Class II · 2016-09-14 · Biomet Microfixation - Plum A+3 Infusion Pump with Hospira MedNet Software
FDA Device · Class II · 2016-09-14 · Hospira - Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data
FDA Device · Class II · 2016-09-14 · Ge Healthcare It - 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems
FDA Device · Class II · 2016-09-14 · Omega Medical Imaging - Pacemakers: Accolade MRI DR Model L311
FDA Device · Class II · 2016-09-14 · Boston Scientific - Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to…
FDA Device · Class II · 2016-09-14 · Integra Lifesciences - SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for AT…
FDA Device · Class II · 2016-09-14 · Hologic - Plum A+3 Infusion Pump
FDA Device · Class II · 2016-09-14 · Hospira - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 008…
FDA Device · Class II · 2016-09-14 · Aspen Surgical Puerto Rico - Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of…
FDA Device · Class II · 2016-09-14 · Best Sanitizers - Plum A+ Hyperbaric Infusion Pump
FDA Device · Class II · 2016-09-14 · Hospira - Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad S…
FDA Device · Class II · 2016-09-14 · Bayer Healthcare - ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD
FDA Device · Class I · 2016-09-14 · Microport Orthopedics - Plum A+ Infusion Pump with Hospira MedNet Software
FDA Device · Class II · 2016-09-14 · Hospira - The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operati…
FDA Device · Class II · 2016-09-14 · Maquet Cardiovascular Us Sales - Plum A+ Infusion Pump
FDA Device · Class II · 2016-09-14 · Hospira - Polypropylene Surgical Sutures, brand Webglo, for vet use
FDA Device · Class II · 2016-09-14 · Riverpoint Medical - Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth
FDA Device · Class II · 2016-09-14 · Anthogyr - Integra Cranial Access Kits, Catalogue Nos
FDA Device · Class II · 2016-09-14 · Integra Lifesciences D B A Integra Pain Management - Medical Linear Accelerator
FDA Device · Class II · 2016-09-14 · Elekta - Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon
FDA Device · Class II · 2016-09-14 · Riverpoint Medical - Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small
FDA Device · Class II · 2016-09-14 · Zimmer Biomet
Other years
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