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.

• HAMILTON-T1 Ventilator with software versions 1.1.2 or lower
  FDA Device · Class I · 2013-02-06 · Hamilton Medical
• Ethicon Endo-Surgery Inc
  FDA Device · Class II · 2013-02-06 · Ethicon Endo Surgery
• TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid…
  FDA Device · Class II · 2013-02-06 · Biomet
• BacT/ALERT SA Blood Culture Bottle
  FDA Device · Class II · 2013-02-06 · Biomerieux
• Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System
  FDA Device · Class II · 2013-02-06 · Envoy Medical
• Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the v…
  FDA Device · Class II · 2013-02-06 · Moog Medical Devices Group
• Extremity Medical, IO FiX System Accessory
  FDA Device · Class II · 2013-02-06 · Extremity Medical
• COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE
  FDA Device · Class II · 2013-02-06 · Roche Molecular Systems
• Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets
  FDA Device · Class II · 2013-02-06 · Varian Medical Systems
• Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets
  FDA Device · Class II · 2013-02-06 · Varian Medical Systems
• Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
  FDA Device · Class II · 2013-02-06 · Motorola
• Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat
  FDA Device · Class II · 2013-02-06 · Cordis
• Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
  FDA Device · Class II · 2013-02-06 · Philips Healthcare
• Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75,…
  FDA Device · Class II · 2013-02-06 · Abbott Vascular
• Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities
  FDA Device · Class II · 2013-02-06 · Mindray Ds Usa D B A Mindray North America
• Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010
  FDA Device · Class III · 2013-02-06 · Siemens Healthcare Diagnostics
• Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100
  FDA Device · Class II · 2013-02-06 · Ortho Clinical Diagnostics
• Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter r…
  FDA Device · Class III · 2013-02-06 · Alere San Diego
• 45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031
  FDA Device · Class II · 2013-02-06 · Greatbatch Medical
• Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY -- Distributed By: CONMED CORPORATION Electrosurgical, Cu…
  FDA Device · Class II · 2013-01-30 · Conmed
• CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No. 137668, Sterile, Rx ONLY -- CONMED CORPORATION Electro…
  FDA Device · Class II · 2013-01-30 · Conmed
• UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY --…
  FDA Device · Class II · 2013-01-30 · Conmed
• UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY --…
  FDA Device · Class II · 2013-01-30 · Conmed
• DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPO…
  FDA Device · Class II · 2013-01-30 · Conmed
• Abbott Point of Care i-Stat cTnI cartridge
  FDA Device · Class II · 2013-01-30 · Abbott Point
• Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ult…
  FDA Device · Class II · 2013-01-30 · Ansell Healthcare Products
• DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CO…
  FDA Device · Class II · 2013-01-30 · Conmed
• Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Elec…
  FDA Device · Class II · 2013-01-30 · Conmed
• Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION Elec…
  FDA Device · Class II · 2013-01-30 · Conmed
• DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONM…
  FDA Device · Class II · 2013-01-30 · Conmed
• DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needl…
  FDA Device · Class II · 2013-01-30 · Medisystems A Nx Stage
• UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY --…
  FDA Device · Class II · 2013-01-30 · Conmed
• Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37…
  FDA Device · Class II · 2013-01-30 · Abbott Laboratories
• DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation…
  FDA Device · Class II · 2013-01-30 · Ams Innovative Center San Jose
• DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicat…
  FDA Device · Class II · 2013-01-30 · Medisystems A Nx Stage
• UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single Use, Sterile, Rx ONLY --CONMED CORPORATION, Electros…
  FDA Device · Class II · 2013-01-30 · Conmed
• UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION, Electros…
  FDA Device · Class II · 2013-01-30 · Conmed
• TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cuttin…
  FDA Device · Class II · 2013-01-30 · Conmed
• UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosu…
  FDA Device · Class II · 2013-01-30 · Conmed
• ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPO…
  FDA Device · Class II · 2013-01-30 · Conmed
• Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -…
  FDA Device · Class II · 2013-01-30 · Conmed
• Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents f…
  FDA Device · Class II · 2013-01-30 · Becton Dickinson And
• Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument
  FDA Device · Class II · 2013-01-30 · Becton Dickinson And
• Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer
  FDA Device · Class III · 2013-01-30 · Roche Diagnostics Operations
• ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPO…
  FDA Device · Class II · 2013-01-30 · Conmed
• UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electros…
  FDA Device · Class II · 2013-01-30 · Conmed
• DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation, REF/Catalog No. 139105EXT, Single Use, Sterile, Rx ONLY --…
  FDA Device · Class II · 2013-01-30 · Conmed
• DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component
  FDA Device · Class II · 2013-01-30 · Depuy Spine
• Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY -…
  FDA Device · Class II · 2013-01-30 · Conmed
• Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Us…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns&a…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS…
  FDA Device · Class I · 2013-01-23 · Vycor Medical
• Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&am…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the qu…
  FDA Device · Class II · 2013-01-23 · Ids Immunodiagnostic Systems
• Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns&am…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• Eterna Giovinezza System, Powered Laser Surgical Instrument
  FDA Device · Class II · 2013-01-23 · Quanta System S P A
• Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product U…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns&am…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galact…
  FDA Device · Class II · 2013-01-23 · Perkinelmer
• Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions
  FDA Device · Class II · 2013-01-23 · Quanta System S P A
• Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231
  FDA Device · Class II · 2013-01-23 · Philips Medical Systems Cleveland
• Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and…
  FDA Device · Class I · 2013-01-23 · Bausch And Lomb
• Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expediu…
  FDA Device · Class II · 2013-01-23 · Depuy Spine
• Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp…
  FDA Device · Class II · 2013-01-23 · Terumo Cardiovascular Systems
• DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
  FDA Device · Class II · 2013-01-23 · Perkinelmer
• Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: Granu…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usa…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465
  FDA Device · Class II · 2013-01-23 · Perkinelmer
• NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measuremen…
  FDA Device · Class II · 2013-01-23 · Perkinelmer
• Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument
  FDA Device · Class II · 2013-01-23 · Quanta System S P A
• Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003
  FDA Device · Class II · 2013-01-23 · Stryker Howmedica Osteonics
• Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03
  FDA Device · Class II · 2013-01-23 · Spacelabs Healthcare
• Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance W…
  FDA Device · Class II · 2013-01-23 · Philips Medical Systems Cleveland
• Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usa…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030
  FDA Device · Class II · 2013-01-23 · Perkinelmer
• Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usa…
  FDA Device · Class III · 2013-01-23 · Fresenius Medical Care Holdings
• Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field
  FDA Device · Class II · 2013-01-16 · California Medical Laboratories
• PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  FDA Device · Class II · 2013-01-16 · Biomet
• Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for…
  FDA Device · Class II · 2013-01-16 · Siemens Healthcare Diagnostics
• ABX PENTRA ML, Software Versions: V8.0.x and Below
  FDA Device · Class II · 2013-01-16 · Horiba Instruments
• Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteon…
  FDA Device · Class II · 2013-01-16 · Stryker Howmedica Osteonics
• Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemen…
  FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics
• Immunoradiometric assay
  FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics
• Immunoradiometric assay
  FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics
• Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissu…
  FDA Device · Class II · 2013-01-16 · Surgical Tissue Network
• Immunoradiometric assay
  FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics
• Merit Medical's Custom Procedural Tray or Kits K12T-03162B &amp
  FDA Device · Class II · 2013-01-16 · Merit Medical Systems
• Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(…
  FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics

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)