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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1501 of 1581

Evidence Product Join Root cause
device-recall:cfres:170375 Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1 Official recall number · Z-0809-2019 Component design/selection
device-recall:cfres:170382 Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01 Official recall number · Z-0811-2019 Component design/selection
device-recall:cfres:170180 VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb. Official recall number · Z-0740-2019 Process design
device-recall:cfres:170186 COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S Official recall number · Z-0775-2019 Error in labeling
device-recall:cfres:170185 COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S Official recall number · Z-0774-2019 Error in labeling
device-recall:cfres:170177 VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb. Official recall number · Z-0737-2019 Process design
device-recall:cfres:171254 Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow Official recall number · Z-1047-2019 Packaging process control
device-recall:cfres:170467 Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only Official recall number · Z-0768-2019 Device Design
device-recall:cfres:168425 Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Official recall number · Z-0780-2019 Software design
device-recall:cfres:170203 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction. Official recall number · Z-0765-2019 Nonconforming Material/Component
device-recall:cfres:170767 BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. Official recall number · Z-0981-2019 Nonconforming Material/Component
device-recall:cfres:170821 Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. Official recall number · Z-0973-2019 Software Design Change
device-recall:cfres:168422 AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Official recall number · Z-0956-2019 Process control
device-recall:cfres:170846 Monaco Radiation Treatment Planning (RTP) System Official recall number · Z-0965-2019 Software design
device-recall:cfres:170523 BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices. Official recall number · Z-0959-2019 Software design
device-recall:cfres:170577 Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea. Official recall number · Z-0961-2019 Device Design
device-recall:cfres:168418 AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump Official recall number · Z-0952-2019 Process control
device-recall:cfres:167244 Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ Official recall number · Z-0714-2019 Process control
device-recall:cfres:169845 MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Official recall number · Z-0821-2019 Software change control
device-recall:cfres:168632 ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma. Official recall number · Z-0799-2019 Device Design
device-recall:cfres:170646 Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0876-2019 Unknown/Undetermined by firm
device-recall:cfres:170661 Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0891-2019 Unknown/Undetermined by firm
device-recall:cfres:169658 AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. Official recall number · Z-0849-2019 Software design
device-recall:cfres:170674 Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System Official recall number · Z-0904-2019 Unknown/Undetermined by firm
device-recall:cfres:170557 Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 Official recall number · Z-0851-2019 Under Investigation by firm

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