FDA (Device enforcement)

11,102 recalls · page 64 of 112

• Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers2023-07-12
• Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers2023-07-12
• Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers2023-07-12
• NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN,2023-07-12
• NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers2023-07-12
• Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers2023-07-12
• EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator2023-07-11
• Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 110975312023-07-10
• Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 115372142023-07-10
• Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 110975972023-07-10
• Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 115372132023-07-10
• LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,2023-07-07
• Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only2023-07-07
• Access Thyroglobulin Calibrators2023-07-06
• TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only2023-07-06
• LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A172023-06-30
• Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems2023-06-30
• 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 50002023-06-30
• Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 10003232023-06-29
• stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery2023-06-28
• ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.2023-06-28
• ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.2023-06-28
• ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.2023-06-28
• ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP2023-06-28
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 88883406292023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP2023-06-28
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 88883406372023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP2023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP2023-06-28
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 88883456032023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP2023-06-28
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 88883456112023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP2023-06-28
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 88883456292023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP2023-06-28
• MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 88883456372023-06-28
• MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP2023-06-28
• Constellation Procedure Pak2023-06-28
• Centurion FMS Pak2023-06-28
• Infinity FMS Pak2023-06-28
• Legion FMS Pak2023-06-28
• Phaco Standalone Tips2023-06-28
• Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, frac2023-06-27
• YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-01 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-022023-06-23
• SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0469-01C SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0469-07 SENSATION 7 2023-06-23
• TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES D684-00-0546-01 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH AC2023-06-23
• MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0295-01 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0295-02 MEGA 7.5Fr. 40cc IAB WITH ACCESSORI2023-06-23
• MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D684-00-0296-01 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA D684-00-0296-02 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLO2023-06-23
• SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES D684-00-0568-01 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) D684-00-0568-03 SENSA2023-06-23
• SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES D684-00-0576-01 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-03 SE2023-06-23
• LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES D684-00-0479-01 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) D684-00-0479-02 LINEAR 7.5Fr. 34cc IAB WITH AC2023-06-23
• REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. D684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. D684-00-0403-06 REIN2023-06-23
• Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with E2023-06-23
• Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-sterile; Surgical Room Turnove2023-06-23
• UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO2023-06-23
• Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.2023-06-22
• Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.2023-06-22
• STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 6211032023-06-22
• STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 6223032023-06-22
• INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE2023-06-22
• A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..2023-06-21
• HoverMatt, 39" W x 78" L, REF: HM39SPU-B2023-06-21
• Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Ur2023-06-21
• Ringed DxI Reaction Vessels (RVs)2023-06-20
• ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 113276002023-06-19
• ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 113277002023-06-19
• ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 108490002023-06-19
• SIGMA Spectrum Infusion Pump, Product Code 35700BAX22023-06-15
• The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35700092023-06-15
• HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates2023-06-15
• HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates2023-06-15
• HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates2023-06-15
• HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates2023-06-15
• MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (S2023-06-15
• IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever2023-06-14
• Impella 2.5 intravascular micro axial blood pump, Product Number 0050422023-06-14
• Impella 5.0 intravascular micro axial blood pump, Product Number 0050622023-06-14
• Impella LD intravascular micro axial blood pump, Product Number 0050822023-06-14
• Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 10001002023-06-14
• Impella CP intravascular micro axial blood pump, Product Number 0048-00322023-06-14
• Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 10000802023-06-14
• Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL14522023-06-14
• Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.2023-06-13
• Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE2023-06-13
• Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)2023-06-13
• Oxylog 3000 Plus emergency and transport ventilator2023-06-12
• AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS6551012023-06-12
• AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS6551182023-06-12