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.
- AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physi…
FDA Device · Class II · 2013-06-12 · Agfa - Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W
FDA Device · Class II · 2013-06-12 · Maytex - SlingBar Standard
FDA Device · Class II · 2013-06-12 · Hill Rom - Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - SlingBar Wide 670
FDA Device · Class II · 2013-06-12 · Hill Rom - Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended…
FDA Device · Class II · 2013-06-12 · Covidien - da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems
FDA Device · Class II · 2013-06-12 · Intuitive Surgical - Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - The Constellation Vision System Pneumatic Handpiece
FDA Device · Class II · 2013-06-12 · Alcon Grieshaber Ag - FLEXSTENT Femoropopliteal Self-Expanding Stent System
FDA Device · Class II · 2013-06-12 · Cordis - Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and…
FDA Device · Class II · 2013-06-12 · Zimmer Surgical - Hill-Rom 1000 Bed, Product No. P1160
FDA Device · Class II · 2013-06-12 · Hill Rom - Active Articulation E1. Intended for use with either primary or revision hip arthroplasty
FDA Device · Class II · 2013-06-12 · Biomet - Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 3…
FDA Device · Class II · 2013-06-12 · Carl Zeiss Meditec - FLEXSTENT Femoropopliteal Self-Expanding Stent System
FDA Device · Class II · 2013-06-12 · Cordis - I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final tra…
FDA Device · Class II · 2013-06-12 · I Flow - GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, S…
FDA Device · Class II · 2013-06-12 · Gyrus Acmi - 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment
FDA Device · Class II · 2013-06-05 · Spinal Solutions - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facili…
FDA Device · Class II · 2013-06-05 · Orthovita - Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr c…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short CERAMIC Ball Head, 32 Medium CERAMI…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - Alere" hCG Combo Cassette (20/10 mIU/mL) Kit
FDA Device · Class II · 2013-06-05 · Alere San Diego - Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming th…
FDA Device · Class II · 2013-06-05 · Elekta - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage…
FDA Device · Class II · 2013-06-05 · Orthovita - Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemen…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, in…
FDA Device · Class II · 2013-06-05 · Beckman Coulter - AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer
FDA Device · Class I · 2013-06-05 · Nephron Pharmaceuticals - Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure)
FDA Device · Class II · 2013-06-05 · Fisher And Paykel Healthcare - 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment
FDA Device · Class II · 2013-06-05 · Spinal Solutions - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Prod…
FDA Device · Class II · 2013-06-05 · Orthovita - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Faci…
FDA Device · Class II · 2013-06-05 · Orthovita - 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment
FDA Device · Class II · 2013-06-05 · Spinal Solutions - U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals wit…
FDA Device · Class II · 2013-06-05 · Polymer Technology Systems - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facil…
FDA Device · Class II · 2013-06-05 · Orthovita - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage…
FDA Device · Class II · 2013-06-05 · Orthovita - RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0
FDA Device · Class II · 2013-06-05 · Raysearch Laboratories Ab - Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment
FDA Device · Class II · 2013-06-05 · Spinal Solutions - EZ Breathe Atomizer Model # EZ-100
FDA Device · Class I · 2013-06-05 · Nephron Pharmaceuticals - Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when use…
FDA Device · Class II · 2013-06-05 · Beckman Coulter - Natus neurology Dantec KEYPOINT.NET 2.20
FDA Device · Class II · 2013-06-05 · Alpine Biomed Aps - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Prod…
FDA Device · Class II · 2013-06-05 · Orthovita - Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring…
FDA Device · Class II · 2013-06-05 · Heart Sync - 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product…
FDA Device · Class II · 2013-06-05 · Spinal Solutions - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage…
FDA Device · Class II · 2013-06-05 · Orthovita - da Vinci Si Surgeon Console
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - Leucadia Autolok" Polyaxial Pedicle Screw System
FDA Device · Class II · 2013-06-05 · Alphatec Spine - 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refracti…
FDA Device · Class II · 2013-06-05 · Canon - adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained…
FDA Device · Class II · 2013-06-05 · Tz Medical - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facili…
FDA Device · Class II · 2013-06-05 · Orthovita - Thyroidectomy Indication for the da Vinci Surgical Systems
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm
FDA Device · Class II · 2013-06-05 · Zimmer - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facil…
FDA Device · Class II · 2013-06-05 · Orthovita - QuietCare
FDA Device · Class II · 2013-06-05 · Intel Ge Care Innovations - Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar C…
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria
FDA Device · Class II · 2013-06-05 · Becton Dickinson And - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Prod…
FDA Device · Class II · 2013-06-05 · Orthovita - Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral,…
FDA Device · Class II · 2013-06-05 · Spinal Solutions - Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consi…
FDA Device · Class II · 2013-06-05 · Spinal Solutions - 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7…
FDA Device · Class II · 2013-06-05 · Spinal Solutions - Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bact…
FDA Device · Class II · 2013-06-05 · Becton Dickinson And - Cannula 8MM Regular
FDA Device · Class II · 2013-06-05 · Intuitive Surgical - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Prod…
FDA Device · Class II · 2013-06-05 · Orthovita - Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment
FDA Device · Class II · 2013-06-05 · Spinal Solutions - Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Faci…
FDA Device · Class II · 2013-06-05 · Orthovita - Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem SCS-Standard Sz 1 Zweimueller Type…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Numbe…
FDA Device · Class II · 2013-06-05 · Angiodynamics - Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radi…
FDA Device · Class II · 2013-06-05 · Merit Medical Systems - QuietCare-Networked
FDA Device · Class II · 2013-06-05 · Intel Ge Care Innovations - UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Pate…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femor…
FDA Device · Class II · 2013-06-05 · Orthopedic Alliance - AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403…
FDA Device · Class II · 2013-06-05 · Angiodynamics - EZ Breathe Medication Cup
FDA Device · Class I · 2013-06-05 · Nephron Pharmaceuticals - ***REF S-3D*** 3mm Diamond Ball
FDA Device · Class II · 2013-06-05 · The Anspach Effort - Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /E…
FDA Device · Class II · 2013-06-05 · Heart Sync - 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment
FDA Device · Class II · 2013-06-05 · Spinal Solutions - Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark
FDA Device · Class II · 2013-05-29 · Coloplast Manufacturing Us - cobas¿ 4800 system z480 instrument
FDA Device · Class II · 2013-05-29 · Roche Molecular Systems - MyRay RXDC dental unit x-ray unit
FDA Device · Class II · 2013-05-29 · Cefla Dental Group - Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system…
FDA Device · Class II · 2013-05-29 · Linvatec - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length, Produc…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length, Product…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Brilliance CT 16-Slice Water, System Code: 728245
FDA Device · Class II · 2013-05-29 · Philips Medical Systems Cleveland - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P003…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only
FDA Device · Class II · 2013-05-29 · Roche Diagnostics Operations - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Len…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product numb…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Le…
FDA Device · Class II · 2013-05-29 · Progressive Medical - Stryker Orthopaedics Triathlon Femoral Distal Augment- Left
FDA Device · Class II · 2013-05-29 · Stryker Howmedica Osteonics - Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatograph…
FDA Device · Class III · 2013-05-29 · Alere San Diego - Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnos…
FDA Device · Class II · 2013-05-29 · Chicago X Ray Systems - Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Leng…
FDA Device · Class II · 2013-05-29 · Progressive Medical
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