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.
- Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN
FDA Device · Class I · 2012-08-22 · Nellcor Puritan Bennett Dba Covidien - Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and di…
FDA Device · Class I · 2012-08-22 · Stryker Instruments Div - Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner…
FDA Device · Class II · 2012-08-22 · Zimmer - Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Univer…
FDA Device · Class II · 2012-08-22 · Philips Healthcare - COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001
FDA Device · Class II · 2012-08-22 · Roche Molecular Systems - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences - 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete…
FDA Device · Class II · 2012-08-22 · Zimmer - 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable ob…
FDA Device · Class II · 2012-08-22 · Nico - Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
FDA Device · Class III · 2012-08-22 · Sunquest Information Systems - i-Stat cTnl cartridges Abbott Point of Care Inc
FDA Device · Class II · 2012-08-15 · Abbott Point - Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is…
FDA Device · Class II · 2012-08-15 · Smith And Nephew Endoscopy Division - CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the C…
FDA Device · Class II · 2012-08-15 · Linvatec - Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0
FDA Device · Class II · 2012-08-15 · Varian Medical Systems Oncology Systems - Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086)
FDA Device · Class III · 2012-08-15 · Siemens Healthcare Diagnostics - Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System…
FDA Device · Class III · 2012-08-15 · Roche Molecular Systems - Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage…
FDA Device · Class II · 2012-08-15 · Smith And Nephew Endoscopy Division - Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
FDA Device · Class II · 2012-08-15 · Philips Healthcare - The ABL software version 6.12 for the ABL800 and ABL700 analyzer
FDA Device · Class II · 2012-08-15 · Radiometer America - AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F
FDA Device · Class II · 2012-08-15 · Angiodynamics Worldwide Headquarters - SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in minimally invasive surgical proc…
FDA Device · Class II · 2012-08-15 · Transenterix - The finger cots are made out of natural rubber
FDA Device · Class II · 2012-08-15 · Afassco - djo surgical Screw 6.5 mm, Sz 25mm, low profile
FDA Device · Class II · 2012-08-15 · Encore Medical - i-Stat BNP cartridges Abbott Point of Care Inc
FDA Device · Class II · 2012-08-15 · Abbott Point - Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Di…
FDA Device · Class II · 2012-08-15 · Medical Specialties Distributors - Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electrob…
FDA Device · Class II · 2012-08-15 · Smith And Nephew Endoscopy Division - AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders
FDA Device · Class I · 2012-08-15 · Baxter Healthcare - SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13
FDA Device · Class II · 2012-08-15 · Scc Soft Computer - Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intend…
FDA Device · Class II · 2012-08-15 · Smith And Nephew Endoscopy Division - I-STAT PT/INR cartridge Abbott Point of Care Inc
FDA Device · Class II · 2012-08-15 · Abbott Point - AUTOMIX Plus High Speed Compounder System, product 2M8075
FDA Device · Class I · 2012-08-15 · Baxter Healthcare - Siemens syngo(R) Lab Data Manager
FDA Device · Class II · 2012-08-15 · Siemens Healthcare Diagnostics - Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures
FDA Device · Class I · 2012-08-15 · Ge Oec Medical Systems - System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perf…
FDA Device · Class II · 2012-08-15 · Terumo Cardiovascular Systems - ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood
FDA Device · Class II · 2012-08-15 · Radiometer America - Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intend…
FDA Device · Class II · 2012-08-15 · Smith And Nephew Endoscopy Division - ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Alm…
FDA Device · Class II · 2012-08-15 · Biomet 3i - AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287
FDA Device · Class I · 2012-08-15 · Baxter Healthcare - Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006
FDA Device · Class III · 2012-08-15 · Impact Instrumentation - Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use
FDA Device · Class II · 2012-08-15 · Stryker Spine - Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: in…
FDA Device · Class II · 2012-08-15 · Smith And Nephew Endoscopy Division - EasyLink(TM) Informatics System, Part Number 1000034805
FDA Device · Class II · 2012-08-15 · Siemens Healthcare Diagnostics - The ABL software version 6.12 for the ABL800 analyzer
FDA Device · Class II · 2012-08-15 · Radiometer America - Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental impl…
FDA Device · Class II · 2012-08-15 · Straumann Usa - 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110
FDA Device · Class II · 2012-08-15 · Greiner Bio One North America - Dimension(R) Reagent Management System (RMS) - Power Cord
FDA Device · Class II · 2012-08-15 · Siemens Healthcare Diagnostics - System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perf…
FDA Device · Class II · 2012-08-15 · Terumo Cardiovascular Systems - PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd
FDA Device · Class II · 2012-08-15 · Linvatec - Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on…
FDA Device · Class II · 2012-08-15 · Fms Finapres Medical Systems Bv - LUXOR RETRACTOR BASE
FDA Device · Class II · 2012-08-15 · Stryker Spine - Kimberly Clark Patient Warming System - Model 1000 Control Unit
FDA Device · Class II · 2012-08-15 · Kimberly Clark - TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067
FDA Device · Class II · 2012-08-15 · Tango3 - Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange
FDA Device · Class II · 2012-08-15 · Apheresis Technologies - i-Stat CK-MP cartridges Abbott Point of Care Inc
FDA Device · Class II · 2012-08-15 · Abbott Point - Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900
FDA Device · Class III · 2012-08-15 · Berchtold - AUTOMIX High Speed Compounder System, product 2M8077
FDA Device · Class I · 2012-08-15 · Baxter Healthcare - Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Device · Class II · 2012-08-08 · Icu Medical - Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight - IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074
FDA Device · Class III · 2012-08-08 · Iris Diagnostics - Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models
FDA Device · Class II · 2012-08-08 · Church And Dwight - KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK
FDA Device · Class II · 2012-08-08 · Intuitive Surgical - Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight - 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
FDA Device · Class II · 2012-08-08 · Icu Medical - STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD te…
FDA Device · Class II · 2012-08-08 · Advanced Sterilization Products - Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis Syst…
FDA Device · Class II · 2012-08-08 · Baxter Healthcare Renal Div - ACCESSORY BASE STARTER KIT,IS3000
FDA Device · Class II · 2012-08-08 · Intuitive Surgical - INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contaminatio…
FDA Device · Class II · 2012-08-08 · Intuitive Surgical - Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight - KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK
FDA Device · Class II · 2012-08-08 · Intuitive Surgical - Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
FDA Device · Class II · 2012-08-08 · Exactech - Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The inst…
FDA Device · Class II · 2012-08-08 · Zimmer - Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses o…
FDA Device · Class II · 2012-08-08 · Beekley - Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant S…
FDA Device · Class II · 2012-08-08 · Aesculap Implant Systems - Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight - Padded Swing Away Arm Rest with Receiver
FDA Device · Class II · 2012-08-08 · Sunrise Medical Us - Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty
FDA Device · Class II · 2012-08-08 · Exactech - RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination…
FDA Device · Class II · 2012-08-08 · Stryker Instruments Div - KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK
FDA Device · Class II · 2012-08-08 · Intuitive Surgical - RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination…
FDA Device · Class II · 2012-08-08 · Stryker Instruments Div - Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bon…
FDA Device · Class II · 2012-08-08 · Integra Lifesciences - The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfect…
FDA Device · Class II · 2012-08-08 · Steris - Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) ser…
FDA Device · Class II · 2012-08-08 · Maquet Medical Systems Usa - Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty
FDA Device · Class II · 2012-08-08 · Exactech - Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment
FDA Device · Class II · 2012-08-08 · Icu Medical - High Pressure Stopcock (3-Way, Luer Lock, Off)
FDA Device · Class II · 2012-08-08 · Icu Medical - OEC MiniView 6800 Mobile
FDA Device · Class II · 2012-08-08 · Ge Oec Medical Systems - Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty
FDA Device · Class II · 2012-08-08 · Exactech - OEC 9800 Plus Digital
FDA Device · Class II · 2012-08-08 · Ge Oec Medical Systems - Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7)
FDA Device · Class II · 2012-08-08 · Exactech - Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zim…
FDA Device · Class II · 2012-08-08 · Zimmer - Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high through…
FDA Device · Class II · 2012-08-08 · Perkinelmer - KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK
FDA Device · Class II · 2012-08-08 · Intuitive Surgical - Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses o…
FDA Device · Class II · 2012-08-08 · Beekley - Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 400…
FDA Device · Class I · 2012-08-08 · Smiths Medical Asd - Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight - Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking ar…
FDA Device · Class II · 2012-08-08 · Beekley - Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight - Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight - Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
FDA Device · Class II · 2012-08-08 · Exactech - Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight
Other years
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