FDA (Device enforcement)

11,102 recalls · page 88 of 112

• Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.102021-07-26
• TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)2021-07-23
• TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)2021-07-23
• Merge Hemo, Software packages 10.2, 10.3, and 10.42021-07-23
• BD" Mouse IgG2a Isotype Control APC X39 ASR2021-07-22
• CritiCool, thermoregulation device2021-07-20
• FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-01272021-07-20
• HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD202021-07-20
• HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD362021-07-20
• Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 60002021-07-20
• (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)2021-07-15
• Pipeline Flex Embolization Device2021-07-13
• EV3 Pipeline Flex Embolization Device with Flex Shield Technology2021-07-13
• Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.2021-07-12
• Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.2021-07-12
• Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.2021-07-12
• Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.2021-07-12
• ACUSON Juniper Diagnostic Ultrasound System2021-07-12
• Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A2902021-07-09
• Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.2021-07-08
• CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.22021-07-05
• Sharesource Connectivity Platform for Use with the Amia Automated PD System2021-06-30
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner,2021-06-29
• Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.2021-06-29
• cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 071540030012021-06-24
• Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA2021-06-23
• TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bo2021-06-23
• EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm2021-06-23
• TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm2021-06-23
• MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.2021-06-22
• Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory 2021-06-18
• Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respira2021-06-18
• ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom2021-06-18
• CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;2021-06-11
• CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;2021-06-11
• CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;2021-06-11
• basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.2021-06-10
• RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; Ray2021-06-08
• 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades2021-06-08
• Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system2021-06-08
• 728332 IQon Spectral CT-Computed Tomography X-ray system2021-06-08
• 728333 Spectral CT 7500 -Computed Tomography X-ray system2021-06-08
• Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 8011882021-06-08
• reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.2021-06-07
• reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.2021-06-07
• FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)2021-06-07
• FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)2021-06-07
• Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.2021-06-07
• Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.2021-06-07
• Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.2021-06-04
• Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.2021-06-04
• HeartWare HVAD Pump Implant Kit, REF 11032021-06-03
• HeartWare HVAD Pump Implant Kit, REF 11042021-06-03
• HeartWare HVAD Pump Implant Kit, REF 11252021-06-03
• HeartWare HVAD Pump Implant Kit, REF 11532021-06-03
• HeartWare HVAD Driveline Extension Cable, REF 1002021-06-03
• HeartWare HVAD Driveline Extension Cable, REF 100US2021-06-03
• HeartWare HVAD Implant Kit, REF 1104JP2021-06-03
• HeartWare HVAD Implant Kit, REF MCS1705PU2021-06-03
• HeartWare HVAD Outflow Graft, REF MCS1725OG2021-06-03
• HeartWare HVAD Pump Accessories, REF MCS1753AK2021-06-03
• ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A2021-06-03
• Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-3013002021-06-02
• Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-3013102021-06-02
• Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-3013122021-06-02
• Medtronic Reveal LINQ LNQ11 / PA960002021-06-01
• Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).2021-05-25
• The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic us2021-05-18
• Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 110670002021-05-13
• Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 110660012021-05-13
• Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 110660002021-05-13
• Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 07470000002021-05-12
• Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 08300000002021-05-12
• Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X2021-05-12
• Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 11150000302021-05-12
• Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿2021-05-12
• InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿2021-05-12
• ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 28500000092021-05-12
• IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 28600009992021-05-12
• S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT2021-05-12
• Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 29720000002021-05-12
• S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX2021-05-12
• TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿33330000002021-05-12
• Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 35000007102021-05-12
• Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿2021-05-12
• Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 50500000002021-05-12
• CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #50500000002021-05-12
• GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX2021-05-12
• Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-112021-05-11
• Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01102021-05-10
• EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia 2021-05-10
• NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA1152021-05-10