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.
- A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV…
FDA Device · Class II · 2013-05-15 · Baxter Healthcare - Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are used for…
FDA Device · Class II · 2013-05-15 · Smiths Medical Asd - Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro¿ Embryo Replacement Catheters are used for the…
FDA Device · Class II · 2013-05-15 · Smiths Medical Asd - Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400
FDA Device · Class III · 2013-05-15 · Spinal Elements - Presource PBDS, Knee Arthroscopy, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110
FDA Device · Class III · 2013-05-15 · Spinal Elements - Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060
FDA Device · Class III · 2013-05-15 · Spinal Elements - Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050
FDA Device · Class III · 2013-05-15 · Spinal Elements - Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070
FDA Device · Class III · 2013-05-15 · Spinal Elements - Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision of a…
FDA Device · Class II · 2013-05-15 · Olympus America - Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Presource PBDS, Total Knee, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080
FDA Device · Class III · 2013-05-15 · Spinal Elements - ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230
FDA Device · Class II · 2013-05-15 · Medshape Solutions - Presource PBDS, Shoulder Procedure, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090
FDA Device · Class III · 2013-05-15 · Spinal Elements - Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile
FDA Device · Class II · 2013-05-15 · Cypress Medical Products - Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030
FDA Device · Class III · 2013-05-15 · Spinal Elements - Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080
FDA Device · Class III · 2013-05-15 · Spinal Elements - Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD P…
FDA Device · Class II · 2013-05-15 · Becton Dickinson And - A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Sin…
FDA Device · Class II · 2013-05-15 · Baxter Healthcare - Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Presource PBDS, Total Joint, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050
FDA Device · Class III · 2013-05-15 · Spinal Elements - Presource PBDS, Major Abdominal, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instr…
FDA Device · Class II · 2013-05-15 · Depuy Mitek A Johnson And Johnson - Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular syst…
FDA Device · Class II · 2013-05-15 · Synthes Usa Hq - Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Presource PBDS, Hand, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040
FDA Device · Class III · 2013-05-15 · Spinal Elements - Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110
FDA Device · Class III · 2013-05-15 · Spinal Elements - Presource PBDS, Extremity, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100
FDA Device · Class III · 2013-05-15 · Spinal Elements - Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070
FDA Device · Class III · 2013-05-15 · Spinal Elements - Presource PBDS, Shoulder Arthroscopy, Kit, Circulator
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only
FDA Device · Class I · 2013-05-15 · Abbott Diabetes Care - Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the intro…
FDA Device · Class II · 2013-05-15 · Smiths Medical Asd - Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only
FDA Device · Class II · 2013-05-15 · Baxter Healthcare - Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30¿ Downward Bend At Proximal End
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
FDA Device · Class II · 2013-05-15 · Symmetry Medical Ssi - Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060
FDA Device · Class III · 2013-05-15 · Spinal Elements - A) Presource PBDS, Lap Chole, Kit, Clean Up
FDA Device · Class I · 2013-05-15 · Cardinal Health Medical Products And Services - Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish
FDA Device · Class II · 2013-05-15 · Stryker Endoscopy - NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with re…
FDA Device · Class II · 2013-05-08 · Nxstage Medical - CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for denta…
FDA Device · Class II · 2013-05-08 · Trophy Sas - STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard met…
FDA Device · Class II · 2013-05-08 · Advanced Sterilization Products - Stryker Howmedica Osteonics Corp
FDA Device · Class II · 2013-05-08 · Stryker Howmedica Osteonics - MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002
FDA Device · Class II · 2013-05-08 · Owens And Minor Distribution - GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-section…
FDA Device · Class II · 2013-05-08 · Ge Healthcare - CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographi…
FDA Device · Class II · 2013-05-08 · Trophy Sas - Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180)
FDA Device · Class I · 2013-05-08 · Maquet Cardiovascular Us Sales - HeartStart MRx Monitor/Defribillator
FDA Device · Class II · 2013-05-08 · Philips Healthcare - Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic
FDA Device · Class I · 2013-05-08 · Medtronic Neuromodulation - GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the h…
FDA Device · Class I · 2013-05-08 · Hospira - Optima MR430s MRI Scanner
FDA Device · Class II · 2013-05-08 · Ge Healthcare - The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec…
FDA Device · Class I · 2013-05-08 · Hospira - GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant
FDA Device · Class II · 2013-05-08 · Ge Healthcare - Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339
FDA Device · Class I · 2013-05-08 · Medtronic Neuromodulation - Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG m…
FDA Device · Class II · 2013-05-08 · Covidien - MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique im…
FDA Device · Class II · 2013-05-08 · Ge Healthcare - GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System
FDA Device · Class II · 2013-05-08 · Ge Healthcare - Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of funct…
FDA Device · Class II · 2013-05-08 · Masimo - The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec…
FDA Device · Class I · 2013-05-08 · Hospira - Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367
FDA Device · Class II · 2013-05-08 · B Braun Medical - Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monit…
FDA Device · Class II · 2013-05-08 · Covidien - GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the h…
FDA Device · Class I · 2013-05-08 · Hospira - Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise…
FDA Device · Class II · 2013-05-08 · Vital Images - Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus
FDA Device · Class I · 2013-05-08 · Newport Medical Instruments - GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device
FDA Device · Class II · 2013-05-08 · Ge Healthcare - Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR…
FDA Device · Class II · 2013-05-08 · Siemens Medical Solutions Usa - SL3 SOFT-TISSUE Laser (Model LR2002)
FDA Device · Class II · 2013-05-08 · Discus Dental - CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographi…
FDA Device · Class II · 2013-05-08 · Trophy Sas - 3DKnee e+ Tibial Insert
FDA Device · Class II · 2013-05-08 · Encore Medical - CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for denta…
FDA Device · Class II · 2013-05-08 · Trophy Sas - GE Healthcare, Xeleris 2 Processing & Review Workstation
FDA Device · Class II · 2013-05-01 · Ge Healthcare - NeuViz Dual series CT Scanner System, Part number (PN): 989605651321
FDA Device · Class II · 2013-05-01 · Philips And Neusoft Medical Systems - Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT
FDA Device · Class II · 2013-05-01 · Stellate Systems - Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod…
FDA Device · Class II · 2013-05-01 · Orthopedic Alliance - NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16
FDA Device · Class II · 2013-05-01 · Philips And Neusoft Medical Systems - ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson - Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used…
FDA Device · Class II · 2013-05-01 · Varian Medical Systems Oncology Systems - VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384
FDA Device · Class II · 2013-05-01 · Ortho Clinical Diagnostics - Sirtex SIR-yttrium 90 microspheres (Radionuclide)
FDA Device · Class III · 2013-05-01 · Sirtex Medical - APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18…
FDA Device · Class II · 2013-05-01 · Spinal Solutions - The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807
FDA Device · Class II · 2013-05-01 · Alere San Diego - Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imag…
FDA Device · Class II · 2013-05-01 · Ge Healthcare - Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
FDA Device · Class II · 2013-05-01 · Nova Biomedical - Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
FDA Device · Class II · 2013-05-01 · Nova Biomedical - Belly Bag Urine Collection Bag with Hip Belt
FDA Device · Class II · 2013-05-01 · Teleflex Medical
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