FDA (Device enforcement)

11,102 recalls · page 93 of 112

• MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients2020-06-23
• PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)2020-06-19
• PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (UDI 00801741175718), 2020-06-19
• PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 008012020-06-19
• PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801742020-06-19
• SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)2020-06-19
• SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)2020-06-19
• SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741082020-06-19
• SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)2020-06-19
• SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)2020-06-19
• SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 00801741066276), LH-0032020-06-19
• PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 2020-06-19
• SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 00801741066306), LH-0037 (UDI 00802020-06-19
• Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / 2020-06-18
• Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for th2020-06-18
• Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scann2020-06-18
• Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.2020-06-18
• Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.2020-06-15
• Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.2020-06-15
• enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrec2020-06-09
• ADVIA Chemistry Calibrator2020-06-05
• Atellica CH Chemistry Calibrator2020-06-05
• OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.2020-06-05
• OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.2020-06-05
• Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.2020-06-04
• Thora-Para 5 Fr Non-Valved Catheter Drainage Tray2020-05-28
• Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray2020-05-28
• Safe-T-Centesis 6 Fr Catheter Drainage Tray2020-05-28
• Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine2020-05-28
• Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray2020-05-28
• Safe-T-Centesis 8 Fr Catheter Drainage Tray2020-05-28
• Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray2020-05-28
• Thora-Para 8 Fr Catheter Drainage Tray2020-05-28
• Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine2020-05-28
• Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free2020-05-28
• Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray2020-05-28
• Thora-Para 5 Fr Catheter Drainage Tray2020-05-28
• Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free2020-05-28
• Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray2020-05-28
• ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F2020-05-22
• Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.5712020-05-21
• VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replac2020-05-21
• RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.2020-05-18
• MEVION S250i, MEVION S250; Proton Radiation Treatment System2020-05-15
• (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and tes2020-05-15
• (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test orderi2020-05-15
• 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.2020-05-15
• Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.2020-05-14
• Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.2020-05-12
• VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and V2020-05-11
• VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VI2020-05-11
• Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including 2020-05-08
• uCT 530 Computed Tomography X-Ray System2020-05-08
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally m2020-05-05
• Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.2020-04-24
• Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.2020-04-24