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 1550 of 1581

Evidence Product Join Root cause
device-recall:cfres:136915 RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. . Official recall number · Z-1740-2015 Nonconforming Material/Component
device-recall:cfres:135907 COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells. Official recall number · Z-1616-2015 Nonconforming Material/Component
device-recall:cfres:135870 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile. Official recall number · Z-1589-2015 Under Investigation by firm
device-recall:cfres:137251 SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. Official recall number · Z-1668-2015 Software design
device-recall:cfres:134555 (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites. Official recall number · Z-1347-2015 Error in labeling
device-recall:cfres:134556 LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites. Official recall number · Z-1348-2015 Error in labeling
device-recall:cfres:135430 ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Official recall number · Z-1442-2015 Process control
device-recall:cfres:134705 da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. Official recall number · Z-1387-2015 Packaging process control
device-recall:cfres:134171 QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended for the quantitative measurement of sodium, potassium, chloride and total carbon dioxide in human serum and heparinized plasma. They are also intended for the quantitative measurement of Na+, K+ and Cl- in urine. Official recall number · Z-1398-2015 Under Investigation by firm
device-recall:cfres:134687 ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management. Official recall number · Z-1369-2015 Software design
device-recall:cfres:134474 Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component. Official recall number · Z-1360-2015 Nonconforming Material/Component
device-recall:cfres:134154 Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Official recall number · Z-1353-2015 Storage
device-recall:cfres:137085 Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Official recall number · Z-1665-2015 Error in labeling
device-recall:cfres:135857 Direct Water feed Kit, Catalog#10373222 Official recall number · Z-1661-2015 Nonconforming Material/Component
device-recall:cfres:137253 SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: Querying and retrieving patient history information and/or previous diagnosis and images from other modalities, including X-ray examinations of the urogenital area, Ultrasound examinations, Endourological interventions, Percutaneous interventions, Laparoscopy, Application of fistula, Simple procedures, Extracorporeal shock wave lithotripsy, Uroflow/urodynamics, Pediatric radiological and therapeutic applications. Official recall number · Z-1670-2015 Software design
device-recall:cfres:135100 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Official recall number · Z-1571-2015 Package design/selection
device-recall:cfres:135440 Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required. Official recall number · Z-1559-2015 Software design
device-recall:cfres:135521 Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery. Official recall number · Z-1553-2015 Device Design
device-recall:cfres:135535 GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx Official recall number · Z-1405-2015 Radiation Control for Health and Safety Act
device-recall:cfres:135963 Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number. Official recall number · Z-1546-2015 Nonconforming Material/Component
device-recall:cfres:135101 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards. Official recall number · Z-1572-2015 Package design/selection
device-recall:cfres:135239 CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use. Official recall number · Z-1483-2015 Nonconforming Material/Component
device-recall:cfres:135254 CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use. Official recall number · Z-1494-2015 Nonconforming Material/Component
device-recall:cfres:135261 CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use. Official recall number · Z-1498-2015 Nonconforming Material/Component
device-recall:cfres:135279 Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Official recall number · Z-1519-2015 Software design

Field note

Send feedback

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