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 1512 of 1581

Evidence Product Join Root cause
device-recall:cfres:155734 Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Official recall number · Z-2295-2017 Under Investigation by firm
device-recall:cfres:155718 Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node Official recall number · Z-2281-2017 Under Investigation by firm
device-recall:cfres:155717 Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. Official recall number · Z-2280-2017 Under Investigation by firm
device-recall:cfres:155743 Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters The Arrow¿ Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The ARROWg+ard¿ antimicrobial surface is intended to help provide protection against sheath-related infections. The sheath is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use. Official recall number · Z-2304-2017 Under Investigation by firm
device-recall:cfres:153151 Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706 Official recall number · Z-1244-2017 Labeling Change Control
device-recall:cfres:151614 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which 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). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer. Official recall number · Z-0980-2017 Mixed-up of materials/components
device-recall:cfres:152289 Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010 Official recall number · Z-1222-2017 Labeling design
device-recall:cfres:152132 Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area Official recall number · Z-1209-2017 Process control
device-recall:cfres:152220 IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. Official recall number · Z-1119-2017 Nonconforming Material/Component
device-recall:cfres:152250 Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality. Official recall number · Z-1128-2017 Package design/selection
device-recall:cfres:152568 Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel¿ tube and outer housing. Official recall number · Z-1190-2017 Device Design
device-recall:cfres:151877 SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143 Official recall number · Z-1111-2017 Material/Component Contamination
device-recall:cfres:150878 Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area. Official recall number · Z-1085-2017 Package design/selection
device-recall:cfres:152174 SwishTapered Implant Official recall number · Z-1112-2017 Packaging process control
device-recall:cfres:144236 Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. Official recall number · Z-1064-2017 Device Design
device-recall:cfres:152176 AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). Official recall number · Z-1039-2017 Device Design
device-recall:cfres:151346 Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241. Official recall number · Z-1003-2017 Under Investigation by firm
device-recall:cfres:150884 Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior Official recall number · Z-1017-2017 Software design
device-recall:cfres:152008 The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043 Official recall number · Z-0975-2017 Use error
device-recall:cfres:151810 Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package. Official recall number · Z-0984-2017 Process control
device-recall:cfres:152021 Fresenius 2008K@home Series : Hemodialysis System Official recall number · Z-1029-2017 Device Design
device-recall:cfres:151142 REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116 Official recall number · Z-1008-2017 Process control
device-recall:cfres:152789 Angio Pack, part number AMS6711 Official recall number · Z-1259-2017 Nonconforming Material/Component
device-recall:cfres:152897 Minor Procedure Pack, part number AMS4799 Official recall number · Z-1342-2017 Nonconforming Material/Component
device-recall:cfres:152857 Head/Neck Pack, part number AMS6121 Official recall number · Z-1314-2017 Nonconforming Material/Component

Field note

Send feedback

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