FDA (Device enforcement)

11,102 recalls · page 41 of 112

• Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device2024-08-20
• Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C2024-08-19
• basixTOUCH Inflation Device, REF: IN8140/A2024-08-19
• DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A2024-08-19
• IntelliSystem Inflation Device, REF: IN1525/D2024-08-19
• BlueFIRE Inflation Device, REF: IN101402024-08-19
• MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B2024-08-19
• Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051,2024-08-19
• basixSKY Inflation Device, REF: SKY18022024-08-19
• basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C2024-08-19
• StabiliT TOUCH Syringe, REF: IN8VCF/B2024-08-19
• Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSION2024-08-19
• Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system2024-08-15
• Alaris PCA Module Model 8120, a modular infusion pump and monitoring system2024-08-15
• Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system2024-08-15
• Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system2024-08-15
• Alaris Pump Module Model 8100, a modular infusion pump and monitoring system2024-08-15
• Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers2024-08-15
• ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.2024-08-15
• SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M20952024-08-15
• STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D2024-08-15
• STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA2024-08-15
• STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L2024-08-15
• STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W2024-08-15
• STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M20962024-08-15
• STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A2024-08-15
• ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.2024-08-15
• ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software2024-08-15
• ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software2024-08-15
• Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS2024-08-13
• Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS2024-08-13
• Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 913302024-08-13
• Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 913312024-08-13
• BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.2024-08-12
• ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-12024-08-12
• ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 722052012024-08-12
• Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable E2024-08-12
• STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion i2024-08-09
• GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-01084972; 11) M1112198-01090848; 12) M1112192024-08-09
• Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 1911302024-08-08
• Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-10662024-08-08
• Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-10642024-08-08
• CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.2024-08-08
• CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.2024-08-08
• CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.2024-08-08
• CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.2024-08-08
• ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological2024-08-08
• DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,2024-08-08
• MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 2090632024-08-07
• Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U2024-08-07
• FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W2024-08-07
• FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U2024-08-07
• PACEMAKER PACK, SLCV01J; Medical convenience kit2024-08-07
• Endovascular AAA Pack, ESED52B; Medical convenience kit2024-08-07
• Endovascular AAA Pack, ESED52B; Medical convenience kit2024-08-07
• Arthroscopy Pack, MSKA45A; Medical convenience kit2024-08-07
• Open Shoulder, LWOS39L; Medical convenience kit2024-08-07
• Day Surgery General Pack, FHGE18T; Medical convenience kit2024-08-07
• Shoulder, SESH18I; Medical convenience kit2024-08-07
• Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit2024-08-07
• Paracentesis Thoracente, SLPT76H; Medical convenience kit2024-08-07
• IR Procedure Pack, CEAT19W; Medical convenience kit2024-08-07
• Neuro Vascular, ANKV91A; Medical convenience kit2024-08-07
• Hand Pack, AKHD97C; Medical convenience kit2024-08-07
• Vaginal Delivery, ASDV25B; Medical convenience kit2024-08-07
• Cath Lab Pack, CECL02P; Medical convenience kit2024-08-07
• Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit2024-08-07
• ENT, COEN27N; Medical convenience kit2024-08-07
• Nasal Sinus Pack, MTSN26B; Medical convenience kit2024-08-07
• Cysto, FTCY03L; Medical convenience kit2024-08-07
• Pacemaker, COPM11B; Medical convenience kit2024-08-07
• Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G246672024-08-07
• Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G246682024-08-07
• Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G546122024-08-07
• Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G546132024-08-07
• Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G546142024-08-07
• Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G463742024-08-07
• Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G463722024-08-07
• Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G463732024-08-07
• Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G466012024-08-07
• Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G466022024-08-07
• Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G466032024-08-07
• Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G466032024-08-07
• PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.2024-08-07
• Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 7222242024-08-06
• General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C2024-08-06
• Impella CP Smart Assist Set, EU; Product Code: 0048-0014;2024-08-05
• Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;2024-08-05
• Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;2024-08-05
• Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;2024-08-05
• Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;2024-08-05
• Pump 371 14F LT CMR Set; Product Code: 0048-0045;2024-08-05
• Impella CP Smart Assist Set APAC; Product Code: 0048-0047;2024-08-05
• Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;2024-08-05
• Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;2024-08-05
• Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;2024-08-05
• Pump 381 Pump Set (US); Product Code: 1000080;2024-08-05
• Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;2024-08-05
• Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;2024-08-05
• ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;2024-08-05