FDA (Device enforcement)

11,102 recalls · page 89 of 112

• Omnera 400T Digital Radiographic System2021-05-05
• Omnera 400A Digital Radiographic System2021-05-05
• Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are n2021-05-04
• VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.2021-05-03
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex2021-05-01
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore2021-05-01
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT2021-05-01
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT2021-05-01
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:2021-05-01
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT2021-05-01
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT2021-05-01
• Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP2021-05-01
• ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 16670012021-04-30
• Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.2021-04-29
• Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.2021-04-29
• Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.2021-04-29
• HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.2021-04-29
• Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.2021-04-29
• Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R2021-04-28
• The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB142021-04-27
• IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.2021-04-26
• Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X2021-04-23
• Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.2021-04-23
• NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-20002021-04-22
• Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M00683182102021-04-15
• UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacte2021-04-15
• T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 3002021-04-15
• Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 794202021-04-09
• Kit: Midline Insertion DA. MAI Kit Part Number: 77981B2021-04-09
• Kit: Blood Culture. MAI Kit Part Number: 80315D2021-04-09
• Kit: Blood Culture MAI Kit Part Number: 800762021-04-09
• ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-042021-04-09
• FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.2021-04-09
• FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-032021-04-09
• DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.2021-04-09
• Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.2021-04-07
• Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.2021-04-07
• ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.2021-03-31
• ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.2021-03-31
• Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.2021-03-31
• AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.2021-03-31
• Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010 Rev B 42021-03-29
• VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.2021-03-29
• Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL23512021-03-29
• InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.2021-03-26
• InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.2021-03-26
• BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 4442132021-03-24
• Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for tran2021-03-23
• VenaSeal Closure System2021-03-23
• Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 092021-03-22
• Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)2021-03-19
• Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.2021-03-19
• VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.2021-03-18
• BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 2215582021-03-17
• BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 2215572021-03-17
• Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-900332021-03-16
• ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.2021-03-15
• ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.2021-03-15
• MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-1886XC 780G V6.5 CLIN MG;¿ PUM2021-03-15
• MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KXS 672021-03-15
• Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).2021-03-11
• Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS2021-03-05
• ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.112021-03-05
• Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S2021-03-05
• Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 1780942021-03-05
• MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.2021-03-05
• MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.2021-03-05
• Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT2021-03-04
• Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV2021-03-04
• Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT2021-03-04
• Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.2021-03-03
• Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.2021-03-02
• BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.2021-03-02
• Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)2021-03-01
• ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).2021-03-01
• Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407I2021-02-26
• Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407I2021-02-26
• Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.2021-02-25
• Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.2021-02-25
• Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.2021-02-25
• Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter2021-02-24
• KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.2021-02-24
• KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.2021-02-24
• Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.2021-02-24
• Incisive CT Computed Tomography X-ray System Model: 7281432021-02-22
• ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylen2021-02-22
• The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.2021-02-22
• The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.2021-02-22
• RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system2021-02-22
• RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.2021-02-18
• VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 87500052021-02-18