FDA (Device enforcement)

11,102 recalls · page 59 of 112

• STERILE PVP SOLUTION, REF DYNDA19072023-11-03
• PVP SOLUTION SING STRL, REF DYNDA18582023-11-03
• STERILE BETADINE, REF DYNDA19982023-11-03
• Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 O2023-11-03
• Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M202023-11-03
• Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COB2023-11-03
• Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-012023-11-02
• Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-022023-11-02
• Sperm separation media are used to separate motile sperm from other constituents of semen.2023-11-02
• Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE2023-11-01
• Atrium Oasis Drain Single W / AC, Part No. 3600-1002023-11-01
• Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)2023-11-01
• PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP2023-10-31
• PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU2023-10-31
• Acrobat-i Vacuum Positioner System, Model Number XP-5000Z2023-10-31
• ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M2023-10-31
• ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G2023-10-31
• Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.2023-10-30
• vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)2023-10-27
• RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 108448132023-10-26
• RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 104914472023-10-26
• RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 104914482023-10-26
• RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 104914492023-10-26
• ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear2023-10-25
• ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear2023-10-25
• ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear2023-10-25
• ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear2023-10-25
• VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System.2023-10-25
• Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.2023-10-25
• CD11b APC: ASR, REF: 340936, and CE, REF: 3331432023-10-25
• Injection Needle, REF: 252072023-10-24
• Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A2023-10-24
• Injection Needle, LUER-lock,0.8mm, REF: 26175PD2023-10-24
• Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 8105062023-10-24
• Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D2023-10-24
• Liberty Select Cycler, Model numbers RTLR180343 and RTLR1801112023-10-24
• GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC02023-10-24
• Achieva 1.5T2023-10-23
• Achieva 1.5T Conversion2023-10-23
• Ingenia 1.5T CX2023-10-23
• SmartPath to dStream for 1.5T2023-10-23
• Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators2023-10-19
• CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A2023-10-19
• CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A2023-10-19
• Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND2023-10-19
• Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS72702023-10-19
• Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS70402023-10-19
• Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS72802023-10-19
• Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS72602023-10-19
• Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS72502023-10-19
• Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP062023-10-19
• Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP042023-10-19
• Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 310042023-10-19
• epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.112023-10-19
• Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.2023-10-19
• Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to2023-10-19
• Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses 2023-10-19
• ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.2023-10-19
• FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmA2023-10-17
• BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-02512023-10-17
• ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 113281002023-10-17
• CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE2023-10-16
• GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE2023-10-16
• GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE2023-10-16
• PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE2023-10-16
• PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE2023-10-16
• Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile; (4) Medline Tracheostomy Care Kit with Gl2023-10-16
• Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System2023-10-16
• AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation2023-10-13
• with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.2023-10-13
• BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT1602023-10-12
• EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q1702023-10-12
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X62023-10-12
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X62023-10-12
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X52023-10-12
• VariSoft infusion set, Model Number 10028272023-10-11
• VariSoft infusion set, Model Number 10028282023-10-11
• VariSoft infusion set, Model Number 10028302023-10-11
• BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD AlarisTM Pump Infusion Set 0.2 Mi2023-10-11
• BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.2023-10-11
• BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET2023-10-11
• Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T2023-10-11
• Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant Resuscitator REF #s: BT2415K, BT242023-10-11
• Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resuscitator REF #s: 6112HZ, 612023-10-11
• Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF 2023-10-11
• Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, SS3200MBF-2, SS3204MBF-22023-10-11
• Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0; 3. STAT-Check Pediatric Resuscitator REF #: SC8121B.2023-10-11
• Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN32023-10-11
• Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, 2023-10-11
• Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resuscitator REF #s: CPRM3312FM, 2023-10-11
• NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E2023-10-11
• NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E2023-10-11
• CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.2023-10-10
• VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.02023-10-10
• VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.02023-10-10
• VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.02023-10-10
• VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.02023-10-10
• VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.02023-10-10
• Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)2023-10-09
• Philips Affiniti 70, Diagnostic Ultrasound System Model # 7952102023-10-09