Skip to content
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 1536 of 1581

Evidence Product Join Root cause
device-recall:cfres:142937 Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. Official recall number · Z-0757-2016 No Marketing Application
device-recall:cfres:142860 ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry. Official recall number · Z-0740-2016 Under Investigation by firm
device-recall:cfres:138999 Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis. Official recall number · Z-0766-2016 Nonconforming Material/Component
device-recall:cfres:144007 Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers. Official recall number · Z-1292-2016 Labeling False and Misleading
device-recall:cfres:144010 Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. Official recall number · Z-1295-2016 Labeling False and Misleading
device-recall:cfres:143501 Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Official recall number · Z-0877-2016 Under Investigation by firm
device-recall:cfres:142968 EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. Official recall number · Z-0992-2016 Device Design
device-recall:cfres:141343 GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. Official recall number · Z-0753-2016 Radiation Control for Health and Safety Act
device-recall:cfres:142997 EndoVive 3s Low Profile Balloon Kits Part Number: M00548810 (XMD P/N 70-0050-G18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. Official recall number · Z-1013-2016 Device Design
device-recall:cfres:142944 EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. Official recall number · Z-0972-2016 Device Design
device-recall:cfres:142966 EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. Official recall number · Z-0990-2016 Device Design
device-recall:cfres:142796 EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. Official recall number · Z-0932-2016 Device Design
device-recall:cfres:142948 Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices. Official recall number · Z-1175-2016 Radiation Control for Health and Safety Act
device-recall:cfres:143421 Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients Official recall number · Z-1226-2016 Nonconforming Material/Component
device-recall:cfres:142642 MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated. Official recall number · Z-1244-2016 Software design
device-recall:cfres:144421 CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters. Official recall number · Z-1250-2016 Nonconforming Material/Component
device-recall:cfres:143858 RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions. Official recall number · Z-1245-2016 Component design/selection
device-recall:cfres:144023 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341. Official recall number · Z-1254-2016 Under Investigation by firm
device-recall:cfres:147342 Certain Preformance 15 degrees Pre-Angled Post Dental implants Official recall number · Z-2491-2016 Packaging
device-recall:cfres:147191 Implant Twist Lock TM Coping Dental implants Official recall number · Z-2472-2016 Packaging
device-recall:cfres:148429 Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. Official recall number · Z-2385-2016 Software design
device-recall:cfres:148491 Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229 Official recall number · Z-2387-2016 Device Design
device-recall:cfres:147362 Certain Temporary Non-Hexed Cylinder Dental implants Official recall number · Z-2499-2016 Packaging
device-recall:cfres:147180 Gold -Tite Hexed Retaining Screw Dental implants Official recall number · Z-2467-2016 Packaging
device-recall:cfres:147619 Certain Gingihue Post Dental implants Official recall number · Z-2523-2016 Packaging

Field note

Send feedback

We'll only use this to respond to your feedback.