FDA Device · 2012
FDA Device recalls in 2012
RecallRadar indexes 1,310 FDA Device recall notices published in 2012. By classification: 95 Class I, 1,162 Class II, 53 Class III.
- Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also ref…
FDA Device · Class I · 2012-07-18 · Alere San Diego - iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200
FDA Device · Class II · 2012-07-18 · Abbott Point - Drager PT 4000 Phototherapy System
FDA Device · Class II · 2012-07-18 · Draeger Medical Systems - The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used…
FDA Device · Class II · 2012-07-18 · Ge Oec Medical Systems - i-Stat Portable Clinical Analyzer
FDA Device · Class II · 2012-07-18 · Abbott Point - Chorus Mobile Patient Lifter
FDA Device · Class II · 2012-07-18 · Arjo - Monaco Product Usage: Planning of radiation therapy
FDA Device · Class II · 2012-07-18 · Elekta - MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines
FDA Device · Class II · 2012-07-18 · Impac Medical Systems - GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.…
FDA Device · Class II · 2012-07-18 · Ge Healthcare - Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulat…
FDA Device · Class I · 2012-07-18 · Alere San Diego - Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656
FDA Device · Class II · 2012-07-18 · Psc Industries - Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile
FDA Device · Class II · 2012-07-18 · Zimmer - Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile
FDA Device · Class II · 2012-07-18 · Zimmer - System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of b…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular…
FDA Device · Class II · 2012-07-18 · Philips Healthcare - Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptid…
FDA Device · Class I · 2012-07-18 · Alere San Diego - Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107
FDA Device · Class II · 2012-07-18 · Stryker Howmedica Osteonics - i-STAT1 Abaxis Analyzer
FDA Device · Class II · 2012-07-18 · Abbott Point - Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199
FDA Device · Class II · 2012-07-18 · Psc Industries - Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator…
FDA Device · Class II · 2012-07-18 · Atom Medical - CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref.…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments - Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656
FDA Device · Class II · 2012-07-18 · Psc Industries - InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus
FDA Device · Class I · 2012-07-18 · Ge Oec Medical Systems - System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of b…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - Focal SIM Planning of radiation therapy
FDA Device · Class II · 2012-07-18 · Elekta - Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood an…
FDA Device · Class II · 2012-07-18 · Smiths Medical Asd - Eon Mini Neurostimulation (IPG) System (Model 3788)
FDA Device · Class II · 2012-07-18 · Advanced Neuromodulation Systems - CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments - Encore Mobile Patient Lifter
FDA Device · Class II · 2012-07-18 · Arjo - Sara Plus Mobile Patient Lifter
FDA Device · Class II · 2012-07-18 · Arjo - Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in E…
FDA Device · Class I · 2012-07-18 · Alere San Diego - Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagn…
FDA Device · Class II · 2012-07-18 · Philips Medical Systems Cleveland - Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937
FDA Device · Class II · 2012-07-18 · Psc Industries - Stryker brand Arthroscope and Hardware Set Tray (sterilization tray)
FDA Device · Class II · 2012-07-18 · Stryker Endoscopy - Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, tr…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments - Intellispace Portal software
FDA Device · Class II · 2012-07-18 · Philips Medical Systems Cleveland - System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories
FDA Device · Class II · 2012-07-18 · Encision - CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, tr…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments - Fuso Analyzer 300F
FDA Device · Class II · 2012-07-18 · Abbott Point - Edwards Lifesciences Rigid Suction Wand, sterile
FDA Device · Class II · 2012-07-18 · Edwards Lifesciences - Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours o…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330
FDA Device · Class II · 2012-07-18 · Integra Lifesciences - CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX…
FDA Device · Class II · 2012-07-18 · Civco Medical Instruments - Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Numbe…
FDA Device · Class II · 2012-07-18 · Psc Industries - PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery
FDA Device · Class II · 2012-07-11 · Zimmer - LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair
FDA Device · Class II · 2012-07-11 · Invacare - Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat
FDA Device · Class II · 2012-07-11 · Pride Mobility Products - Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe,…
FDA Device · Class II · 2012-07-11 · Microbiologics - LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek l…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange
FDA Device · Class II · 2012-07-11 · Philips Healthcare - AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated
FDA Device · Class I · 2012-07-11 · Carefusion 2200 - ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek li…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek l…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical scr…
FDA Device · Class II · 2012-07-11 · Aesculap Implant Systems - LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs an…
FDA Device · Class III · 2012-07-11 · Integra Lifesciences D B A Integra Pain Management - ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek li…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek l…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413
FDA Device · Class II · 2012-07-11 · Depuy Mitek A Johnson And Johnson - AirLife¿ MiniSpacer¿ MDI Dispenser Adapter
FDA Device · Class II · 2012-07-11 · Thayer Medical - Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411
FDA Device · Class II · 2012-07-11 · Depuy Mitek A Johnson And Johnson - Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611
FDA Device · Class II · 2012-07-11 · Depuy Mitek A Johnson And Johnson - LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek l…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613
FDA Device · Class II · 2012-07-11 · Depuy Mitek A Johnson And Johnson - LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one
FDA Device · Class II · 2012-07-11 · Greiner Bio One North America - ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek li…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek l…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek li…
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector
FDA Device · Class I · 2012-07-11 · Carefusion 2200 - LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
FDA Device · Class II · 2012-07-11 · Depuy Orthopaedics - AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated
FDA Device · Class I · 2012-07-11 · Carefusion 2200 - SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE NEEDLE, RECTANGULAR FLANGE, 6" (15 CM) LONG Product…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the a…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China
FDA Device · Class II · 2012-07-04 · Colgate Palmolive - X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in th…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in t…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement i…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for…
FDA Device · Class II · 2012-07-04 · Siemens Healthcare Diagnostics - X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the a…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to del…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08…
FDA Device · Class I · 2012-07-04 · Fresenius Medical Care Holdings - INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems - Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China
FDA Device · Class II · 2012-07-04 · Colgate Palmolive - Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as critical care environments
FDA Device · Class II · 2012-07-04 · Stryker Medical Division - X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in th…
FDA Device · Class II · 2012-07-04 · Terumo Cardiovascular Systems
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)