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 1537 of 1581

Evidence Product Join Root cause
device-recall:cfres:147201 Locator Abutment Impression Coping Dental implants Official recall number · Z-2481-2016 Packaging
device-recall:cfres:143452 Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants Official recall number · Z-2410-2016 Packaging
device-recall:cfres:147943 Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow. Official recall number · Z-2365-2016 Process control
device-recall:cfres:146830 Conical EP Pick-Up Coping (Non-Hexed) Dental implants Official recall number · Z-2454-2016 Packaging
device-recall:cfres:148411 Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. Official recall number · Z-2379-2016 Software design
device-recall:cfres:147610 Certain Gingihue 15 degree Pre- Angled Post Dental implants Official recall number · Z-2522-2016 Packaging
device-recall:cfres:147895 Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body. Official recall number · Z-2114-2016 Nonconforming Material/Component
device-recall:cfres:146712 LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest. Official recall number · Z-2100-2016 Component change control
device-recall:cfres:145351 Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations. Official recall number · Z-2070-2016 Device Design
device-recall:cfres:115180 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways. Official recall number · Z-2056-2016 Software design
device-recall:cfres:145347 Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations. Official recall number · Z-2068-2016 Device Design
device-recall:cfres:144568 Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 Official recall number · Z-2050-2016 Device Design
device-recall:cfres:144729 Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems Official recall number · Z-1578-2016 Labeling design
device-recall:cfres:144203 Automated peritoneal dialysis (APD) cycler Official recall number · Z-1565-2016 Under Investigation by firm
device-recall:cfres:145298 Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data. Official recall number · Z-1620-2016 Device Design
device-recall:cfres:145218 Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery. Official recall number · Z-1602-2016 Labeling mix-ups
device-recall:cfres:144896 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis. Official recall number · Z-1536-2016 Process control
device-recall:cfres:144544 Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System. Official recall number · Z-1622-2016 Nonconforming Material/Component
device-recall:cfres:145098 CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee. Official recall number · Z-1634-2016 Device Design
device-recall:cfres:144598 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual. Official recall number · Z-1641-2016 Labeling Change Control
device-recall:cfres:144711 Dimension Assays: Uric Acid (URCA) Official recall number · Z-1662-2016 Device Design
device-recall:cfres:145039 AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula. Official recall number · Z-1702-2016 Environmental control
device-recall:cfres:145978 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007 Official recall number · Z-1680-2016 Packaging change control
device-recall:cfres:145038 Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula. Official recall number · Z-1701-2016 Environmental control
device-recall:cfres:145397 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries. Official recall number · Z-1693-2016 Process control

Field note

Send feedback

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