FDA Device · 2013
FDA Device recalls in 2013
RecallRadar indexes 2,249 FDA Device recall notices published in 2013. By classification: 177 Class I, 1,944 Class II, 128 Class III.
- BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Compa…
FDA Device · Class II · 2013-07-31 · Becton Dickinson And - Eon Mini - 3721 (Charger)
FDA Device · Class II · 2013-07-24 · St Jude Medical - B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation produc…
FDA Device · Class II · 2013-07-24 · Roche Diagnostics Operations - CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe
FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems - 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex
FDA Device · Class II · 2013-07-24 · Karl Storz Endoscopy America - TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100)
FDA Device · Class III · 2013-07-24 · Technidata - Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
FDA Device · Class II · 2013-07-24 · Siemens Medical Solutions Usa - CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module
FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems - Integra PANTA Arthrodesis Nail System
FDA Device · Class II · 2013-07-24 · Integra Lifesciences - Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for m…
FDA Device · Class II · 2013-07-24 · Synthes Usa Hq - Safety Lancets - Odyssey, Button Activated
FDA Device · Class II · 2013-07-24 · Koojoo Trading - MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump)…
FDA Device · Class I · 2013-07-24 · Codman And Shurtleff - CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules
FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems - CDI Blood Parameter Monitoring System 500 with Venous blood parameter module
FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems - LifeShield
FDA Device · Class II · 2013-07-24 · Hospira - Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been r…
FDA Device · Class II · 2013-07-24 · Staar Surgical - Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company
FDA Device · Class II · 2013-07-24 · Leibel Flarsheim - Eon - 3701 (Wall Charger) and 3711 (Portable Charger)
FDA Device · Class II · 2013-07-24 · St Jude Medical - CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performanc…
FDA Device · Class II · 2013-07-24 · Stryker Instruments Div - Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell cu…
FDA Device · Class II · 2013-07-24 · Paa Laboratories - RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intende…
FDA Device · Class II · 2013-07-24 · Stryker Instruments Div - Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, rea…
FDA Device · Class II · 2013-07-24 · Stryker Instruments Div - ExactaMix 1200 and 2400 Compounders
FDA Device · Class II · 2013-07-24 · Baxa - KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicl…
FDA Device · Class II · 2013-07-24 · Spinefrontier - MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US…
FDA Device · Class I · 2013-07-24 · Codman And Shurtleff - Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correctio…
FDA Device · Class II · 2013-07-24 · Synthes Usa Hq - Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System
FDA Device · Class II · 2013-07-24 · Boston Scientific - Polarizer D Fixed w/Rotating Red 1 lambda plate
FDA Device · Class II · 2013-07-24 · Zeiss Carl - Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended f…
FDA Device · Class II · 2013-07-24 · Edwards Lifesciences - nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by catara…
FDA Device · Class II · 2013-07-24 · Staar Surgical - CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe
FDA Device · Class II · 2013-07-24 · Terumo Cardiovascular Systems - REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated…
FDA Device · Class II · 2013-07-17 · Integra Lifesciences - GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
FDA Device · Class II · 2013-07-17 · Deroyal Industries - da Vinci Instrument Control Box, model number ICB3000
FDA Device · Class II · 2013-07-17 · Intuitive Surgical - REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartmen…
FDA Device · Class II · 2013-07-17 · Biomet - Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300
FDA Device · Class II · 2013-07-17 · Abbott Medical Optics - REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - Tracoe Mini 3.0mm Tube, for pediatric use
FDA Device · Class I · 2013-07-17 · Bryan Medical - Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30…
FDA Device · Class II · 2013-07-17 · Baxter Healthcare - Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe p…
FDA Device · Class II · 2013-07-17 · Fresenius Medical Care Holdings - REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30…
FDA Device · Class II · 2013-07-17 · Baxter Healthcare - Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps
FDA Device · Class I · 2013-07-17 · Medtronic Minimed - REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep…
FDA Device · Class II · 2013-07-17 · Sagatech Electronics - REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment…
FDA Device · Class II · 2013-07-17 · Biomet - Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30…
FDA Device · Class II · 2013-07-17 · Baxter Healthcare - REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartmen…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - NephroMax high Pressure nephrostomy Balloon Catheter Kit
FDA Device · Class II · 2013-07-17 · Boston Scientific - Fresenius Service Replacement 0-Ring
FDA Device · Class II · 2013-07-17 · Fresenius Medical Care Holdings - REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter…
FDA Device · Class II · 2013-07-17 · Baxter Healthcare - REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - Cardio Medical Products, Inc
FDA Device · Class II · 2013-07-17 · Cardio Medical Products - Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
FDA Device · Class II · 2013-07-17 · Siemens Medical Solutions Usa - REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation Rigifl…
FDA Device · Class III · 2013-07-17 · Boston Scientific - NephroMax high Pressure Nephrostomy Balloon Catheter
FDA Device · Class II · 2013-07-17 · Boston Scientific - REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - da Vinci Si Vision System Cart, model number VS3000
FDA Device · Class II · 2013-07-17 · Intuitive Surgical - REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892
FDA Device · Class II · 2013-07-17 · Angiodynamics - REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic jo…
FDA Device · Class II · 2013-07-17 · Zimmer - REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartmen…
FDA Device · Class II · 2013-07-17 · Biomet - Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Us…
FDA Device · Class II · 2013-07-17 · Baxter Healthcare - Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Us…
FDA Device · Class II · 2013-07-17 · Baxter Healthcare - REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set
FDA Device · Class II · 2013-07-17 · Linvatec - REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Device · Class II · 2013-07-17 · Toshiba American Medical Systems - da Vinci Si Surgeon Side Cart, model number SS3000
FDA Device · Class II · 2013-07-17 · Intuitive Surgical - ***REF C7120***APEX Arthroscopy Tubing Set
FDA Device · Class II · 2013-07-17 · Linvatec - da Vinci Dual Camera Controller, model number DC3000
FDA Device · Class II · 2013-07-17 · Intuitive Surgical - REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartme…
FDA Device · Class II · 2013-07-17 · Biomet - - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465,…
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture Grasper (Pink) 60 Degree Ref. 251723 Lot 122631 Passer
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30
FDA Device · Class II · 2013-07-10 · Zimmer - 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product U…
FDA Device · Class II · 2013-07-10 · Ortho Clinical Diagnostics - ***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approx…
FDA Device · Class II · 2013-07-10 · The Anspach Effort - Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder
FDA Device · Class II · 2013-07-10 · Braemar - -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010…
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 - CLEAR-TRAC Flexible Cannula…
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings
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)