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 1509 of 1581

Evidence Product Join Root cause
device-recall:cfres:154926 VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support. Official recall number · Z-2092-2017 Process control
device-recall:cfres:153500 VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use. Official recall number · Z-1887-2017 Under Investigation by firm
device-recall:cfres:154929 Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V Official recall number · Z-1894-2017 Labeling mix-ups
device-recall:cfres:155744 ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy; infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values; frequent blood sampling or blodd/blood component infusions; infusion of incompatible medications; central venous pressure monitoring; lack of usable peripheral IV sites; replacement of multiple peripheral sites for IV access Official recall number · Z-2305-2017 Under Investigation by firm
device-recall:cfres:152778 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures. Official recall number · Z-2107-2017 Process control
device-recall:cfres:154948 Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument Official recall number · Z-2075-2017 Software design
device-recall:cfres:154093 enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD Official recall number · Z-2077-2017 Software design
device-recall:cfres:153694 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307. Official recall number · Z-2057-2017 Labeling Change Control
device-recall:cfres:154407 Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. The cobas c 311 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. Official recall number · Z-2049-2017 Component change control
device-recall:cfres:154881 Savaria SL-1000 Stairlift Official recall number · Z-2060-2017 Component design/selection
device-recall:cfres:155455 SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent Official recall number · Z-2207-2017 Labeling mix-ups
device-recall:cfres:154739 Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000 Official recall number · Z-2217-2017 Device Design
device-recall:cfres:155474 AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections. Official recall number · Z-2215-2017 Process control
device-recall:cfres:155440 Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent Official recall number · Z-2201-2017 Labeling mix-ups
device-recall:cfres:154563 Dimension Vista Estradiol (E2) Flex reagent cartridge Official recall number · Z-2608-2017 Under Investigation by firm
device-recall:cfres:154669 RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1) Official recall number · Z-1919-2017 Error in labeling
device-recall:cfres:152330 10.5CM ANGLE ATTACHMENT, BLACK MAX Official recall number · Z-1973-2017 Under Investigation by firm
device-recall:cfres:152345 Rotating Adult Craniotome Product Usage: Pneumatic system Official recall number · Z-1988-2017 Under Investigation by firm
device-recall:cfres:154717 Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation Official recall number · Z-1927-2017 Nonconforming Material/Component
device-recall:cfres:152337 6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system Official recall number · Z-1980-2017 Under Investigation by firm
device-recall:cfres:152349 Compact Speed Reducer, 60:1 Official recall number · Z-1992-2017 Under Investigation by firm
device-recall:cfres:152088 Foot Control, SC2100 Product Usage: Electric system Official recall number · Z-1953-2017 Under Investigation by firm
device-recall:cfres:152370 8.0cm Medium Attachment Product Usage: Pneumatic system Official recall number · Z-2012-2017 Under Investigation by firm
device-recall:cfres:152064 AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system Official recall number · Z-1932-2017 Under Investigation by firm
device-recall:cfres:152327 90 DEG RIGHT ANGLE ATTACH, BLACK MAX Official recall number · Z-1971-2017 Under Investigation by firm

Field note

Send feedback

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