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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 73 of 1581

Evidence Product Join Root cause
device-recall:cfres:186140 Cardiosave Rescue 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 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Official recall number · Z-1507-2021 Software design
device-recall:cfres:186712 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. Official recall number · Z-1534-2021 Process control
device-recall:cfres:186693 Regard Dressing Change Tray Official recall number · Z-1542-2021 Package design/selection
device-recall:cfres:184600 ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures Official recall number · Z-1260-2021 Component design/selection
device-recall:cfres:186019 In-View Clear Leggings Bulk Non-Sterile Official recall number · Z-1302-2021 Nonconforming Material/Component
device-recall:cfres:185885 Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset. Official recall number · Z-1312-2021 Process design
device-recall:cfres:186307 Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids. Official recall number · Z-1487-2021 Device Design
device-recall:cfres:186306 BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. Official recall number · Z-1460-2021 Device Design
device-recall:cfres:186458 VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure. Official recall number · Z-1489-2021 Under Investigation by firm
device-recall:cfres:186311 BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. Official recall number · Z-1462-2021 Device Design
device-recall:cfres:186877 Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B Official recall number · Z-1557-2021 Package design/selection
device-recall:cfres:186829 REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1585-2021 Component design/selection
device-recall:cfres:186835 REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1588-2021 Component design/selection
device-recall:cfres:187011 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 system Official recall number · Z-1597-2021 Software design
device-recall:cfres:186824 REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1580-2021 Component design/selection
device-recall:cfres:186823 REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1579-2021 Component design/selection
device-recall:cfres:186816 REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein). Official recall number · Z-1573-2021 Component design/selection
device-recall:cfres:186876 Kit: Midline Insertion DA. MAI Kit Part Number: 77981B Official recall number · Z-1556-2021 Package design/selection
device-recall:cfres:186818 REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1574-2021 Component design/selection
device-recall:cfres:187127 NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 Official recall number · Z-1549-2021 Process change control
device-recall:cfres:185978 Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells. Official recall number · Z-1345-2021 Under Investigation by firm
device-recall:cfres:185877 Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems Official recall number · Z-1330-2021 Software Design Change
device-recall:cfres:185960 BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. Official recall number · Z-1335-2021 Process change control
device-recall:cfres:186026 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. Official recall number · Z-1316-2021 Packaging change control
device-recall:cfres:186940 Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. Official recall number · Z-1602-2021 Under Investigation by firm

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