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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 1567 of 1581

Evidence Product Join Root cause
device-recall:cfres:114734 Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Official recall number · Z-0779-2013 Component design/selection
device-recall:cfres:115217 BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing. Official recall number · Z-0911-2013 Equipment maintenance
device-recall:cfres:116218 Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. Official recall number · Z-0923-2013 Mixed-up of materials/components
device-recall:cfres:114490 DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component. Official recall number · Z-0706-2013 Component change control
device-recall:cfres:114495 DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component. Official recall number · Z-0707-2013 Component change control
device-recall:cfres:115553 CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein. Official recall number · Z-0832-2013 Nonconforming Material/Component
device-recall:cfres:115069 HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue. Official recall number · Z-0825-2013 Incorrect or no expiration date
device-recall:cfres:115438 Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic. Official recall number · Z-0819-2013 Nonconforming Material/Component
device-recall:cfres:114844 Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Official recall number · Z-0882-2013 Software design
device-recall:cfres:108418 Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator. Official recall number · Z-0894-2013 Device Design
device-recall:cfres:114846 Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Official recall number · Z-0883-2013 Software design
device-recall:cfres:113677 Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Official recall number · Z-0786-2013 Radiation Control for Health and Safety Act
device-recall:cfres:115405 GE Healthcare Definium 5000 / 5220493 X-Ray System Official recall number · Z-0703-2013 Software design
device-recall:cfres:115190 COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Official recall number · Z-0762-2013 Component change control
device-recall:cfres:115291 Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545 Official recall number · Z-0758-2013 Process control
device-recall:cfres:115457 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Official recall number · Z-0856-2013 Component design/selection
device-recall:cfres:115465 NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Official recall number · Z-0864-2013 Component design/selection
device-recall:cfres:115466 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Official recall number · Z-0865-2013 Component design/selection
device-recall:cfres:115453 NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Official recall number · Z-0852-2013 Component design/selection
device-recall:cfres:115542 Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation Official recall number · Z-0871-2013 Software design
device-recall:cfres:115454 NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Official recall number · Z-0853-2013 Component design/selection
device-recall:cfres:115452 NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Official recall number · Z-0851-2013 Component design/selection
device-recall:cfres:115660 LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). Official recall number · Z-0838-2013 Device Design
device-recall:cfres:115451 NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices Official recall number · Z-0850-2013 Component design/selection
device-recall:cfres:113975 Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications. Official recall number · Z-0764-2013 Nonconforming Material/Component

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