FDA (Device enforcement)

11,102 recalls · page 107 of 112

• Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.2017-08-07
• Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal2017-08-01
• Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 007843022017-08-01
• Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to2017-07-28
• iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular struc2017-07-27
• iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digit2017-07-27
• iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion ce2017-07-27
• VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip2017-07-27
• A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .2017-07-27
• A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.2017-07-27
• NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.2017-07-24
• GENICON EZEE Retrieval, sterile, Rx only.2017-07-19
• BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.2017-07-18
• BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.2017-07-18
• BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.2017-07-18
• ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 20142017-07-17
• Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dua2017-07-17
• MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to t2017-07-14
• MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device2017-07-14
• The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.2017-07-13
• Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.2017-07-13
• Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.2017-07-13
• Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-098802017-07-07
• Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame,2017-07-05
• Persona Partial Knee System, Size 8, Finishing Guide2017-07-05
• DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery2017-06-22
• DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae2017-06-22
• DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hour2017-06-22
• DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.2017-06-22
• DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.2017-06-22
• FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in al2017-06-15
• VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemi2017-06-12
• Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (ST2017-06-06
• Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.2017-06-06
• Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit con2017-06-06
• Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.2017-06-06
• Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus2017-06-06
• PENTARAY NAV High-Density Mapping Catheter.2017-05-17
• PENTARAY NAV High-Density Mapping Catheter.2017-05-17
• DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft2017-05-12
• DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft2017-05-12
• DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft2017-05-12
• DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft2017-05-12
• DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft2017-05-12
• Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and obli2017-05-11
• Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and o2017-05-11
• Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique imag2017-05-11
• Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique im2017-05-11
• Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, corona2017-05-11
• SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, 2017-05-11
• 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿ HDx MR system is indicate2017-05-11
• 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic ima2017-05-11
• Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isoce2017-05-11
• NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.2017-04-28
• VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H2017-04-28
• VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H2017-04-28
• R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG2017-04-28
• FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL 15MMDX38CM FEM IM NAIL 11MMDX40CM 2017-04-28
• TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TI2017-04-28
• FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MMDX34CM RIGHT FEM IM NAIL 13M2017-04-28
• Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV2017-04-28
• 4.5 BROAD SCP PLT 26-H STER2017-04-28
• AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe o2017-04-27
• Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labele2017-04-26
• ARIES System and ARIES M1 System2017-04-19
• SonarMed AirWave Monitor, Model Number M00012017-04-17
• Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan2017-04-12
• 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and2017-03-28
• Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching2017-03-24
• Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching2017-03-24
• Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching2017-03-24
• Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching2017-03-24
• Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm2017-03-24
• Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching2017-03-24
• Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analys2017-03-21
• GIZA Vertebral Body Replacement2017-03-17
• BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed t2017-03-16
• Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated V2017-03-13
• Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.2017-03-10
• Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.2017-03-10
• enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD2017-03-08
• eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intend2017-03-02
• Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx2017-03-01
• Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28
• Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants2017-02-28