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.
- SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and re…
FDA Device · Class II · 2012-12-26 · Bausch And Lomb - SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with sever…
FDA Device · Class II · 2012-12-26 · Zimmer - Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and o…
FDA Device · Class II · 2012-12-26 · Medrad - MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633
FDA Device · Class II · 2012-12-26 · Integra Lifesciences - Patient Circuit used with the Life Pulse High Frequency Ventilator
FDA Device · Class I · 2012-12-26 · Bunnell - EEG NeuroAmp, Model Number: CS 10090
FDA Device · Class II · 2012-12-26 · Eeg Info - Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This…
FDA Device · Class II · 2012-12-26 · Zimmer - Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left
FDA Device · Class II · 2012-12-26 · Zimmer - GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor
FDA Device · Class II · 2012-12-26 · Ge Healthcare - Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left
FDA Device · Class II · 2012-12-26 · Zimmer - SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who require medications and other fluids…
FDA Device · Class II · 2012-12-26 · Medrad - SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left
FDA Device · Class II · 2012-12-26 · Zimmer - Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with…
FDA Device · Class II · 2012-12-26 · Zimmer - MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101
FDA Device · Class II · 2012-12-26 · Integra Lifesciences - SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant…
FDA Device · Class II · 2012-12-26 · Titan Spine - SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for applicati…
FDA Device · Class II · 2012-12-26 · Biomet - Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with…
FDA Device · Class II · 2012-12-26 · Zimmer - Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for…
FDA Device · Class II · 2012-12-26 · Zimmer - Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT
FDA Device · Class II · 2012-12-26 · Zimmer - BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine
FDA Device · Class II · 2012-12-26 · Del Mar Reynolds Medical - Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids…
FDA Device · Class II · 2012-12-26 · Medrad - Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other…
FDA Device · Class II · 2012-12-26 · Medrad - SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Medline Angio Drape Pack Radiology-LF
FDA Device · Class II · 2012-12-26 · Medline Industries - SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System
FDA Device · Class II · 2012-12-26 · Arobella Medical - SpineSix consists of a motorized treatment table that is controlled by an integral computer
FDA Device · Class II · 2012-12-26 · Biomotion Medical Systems - SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244
FDA Device · Class II · 2012-12-26 · Biohorizons Implant Systems - Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube fo…
FDA Device · Class II · 2012-12-26 · Varian Medical Systems - Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left
FDA Device · Class II · 2012-12-26 · Zimmer - AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244
FDA Device · Class II · 2012-12-26 · Biohorizons Implant Systems - Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left
FDA Device · Class II · 2012-12-26 · Zimmer - The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of…
FDA Device · Class II · 2012-12-26 · Stryker Medical Division - Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton
FDA Device · Class II · 2012-12-26 · Invacare - DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and…
FDA Device · Class II · 2012-12-26 · Depuy Mitek A Johnson And Johnson - SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086
FDA Device · Class II · 2012-12-26 · Medtronic Neuromodulation - Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other flui…
FDA Device · Class II · 2012-12-26 · Medrad - SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left
FDA Device · Class II · 2012-12-26 · Zimmer - The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH…
FDA Device · Class II · 2012-12-26 · Beckman Coulter - Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids d…
FDA Device · Class II · 2012-12-26 · Medrad - Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only whe…
FDA Device · Class II · 2012-12-26 · Ge Healthcare - SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G RIGHT This…
FDA Device · Class II · 2012-12-26 · Zimmer - SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Biomet Polaris 5.5 Button Lock Screw Inserter
FDA Device · Class II · 2012-12-26 · Ebi - Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This…
FDA Device · Class II · 2012-12-26 · Zimmer - SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STER…
FDA Device · Class II · 2012-12-26 · Zimmer - Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fl…
FDA Device · Class II · 2012-12-26 · Medrad - Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications an…
FDA Device · Class II · 2012-12-26 · Medrad - Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This…
FDA Device · Class II · 2012-12-26 · Zimmer - ThyssenKrupp Accessibility LEVANT Stairlift
FDA Device · Class II · 2012-12-26 · Thyssenkrupp Access - CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument
FDA Device · Class II · 2012-12-26 · Dako Denmark A S - Medline Total Knee CDS
FDA Device · Class II · 2012-12-26 · Medline Industries - EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp)
FDA Device · Class II · 2012-12-26 · Biomet - Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for…
FDA Device · Class II · 2012-12-26 · Zimmer - SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications a…
FDA Device · Class II · 2012-12-26 · Medrad - Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W…
FDA Device · Class II · 2012-12-26 · Mindray Ds Usa D B A Mindray North America - Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR pr…
FDA Device · Class II · 2012-12-26 · Medrad - Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The u…
FDA Device · Class II · 2012-12-26 · Zimmer - SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points
FDA Device · Class II · 2012-12-26 · Depuy Orthopaedics - BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Ph…
FDA Device · Class II · 2012-12-26 · Becton Dickinson And - Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and other fl…
FDA Device · Class II · 2012-12-26 · Medrad - Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57,…
FDA Device · Class II · 2012-12-26 · Becton Dickinson And - GE Healthcare, Dash 3000/4000/5000
FDA Device · Class II · 2012-12-26 · Ge Healthcare - Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Af…
FDA Device · Class II · 2012-12-26 · Varian Medical Systems Oncology Systems - Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used with the Persona Knee System for…
FDA Device · Class II · 2012-12-26 · Zimmer - DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking
FDA Device · Class II · 2012-12-19 · Hospira - Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitr…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Compan…
FDA Device · Class II · 2012-12-19 · Becton Dickinson And - Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to…
FDA Device · Class II · 2012-12-19 · Covidien - The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system fo…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Cent…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent
FDA Device · Class II · 2012-12-19 · Leica Microsystems - Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the…
FDA Device · Class II · 2012-12-19 · Siemens Healthcare Diagnostics - DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd
FDA Device · Class II · 2012-12-19 · Mindray Ds Usa D B A Mindray North America - Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), e…
FDA Device · Class II · 2012-12-19 · Roche Diagnostics Operations - Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ Taq…
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer
FDA Device · Class II · 2012-12-19 · Roche Molecular Systems - The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a re…
FDA Device · Class I · 2012-12-19 · Verathon - Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Softwa…
FDA Device · Class II · 2012-12-19 · Philips Healthcare - SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump
FDA Device · Class I · 2012-12-19 · Medtronic Neuromodulation
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)