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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 1526 of 1581

Evidence Product Join Root cause
device-recall:cfres:160330 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM Official recall number · Z-0437-2018 Process change control
device-recall:cfres:160852 Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e. Evera MRI S DR ICD DF4 (Product No. DDMC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices). Official recall number · Z-0585-2018 Process design
device-recall:cfres:160285 The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures. Official recall number · Z-0507-2018 Device Design
device-recall:cfres:160395 Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM Official recall number · Z-0473-2018 Process change control
device-recall:cfres:160331 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM Official recall number · Z-0438-2018 Process change control
device-recall:cfres:160413 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM Official recall number · Z-0482-2018 Process change control
device-recall:cfres:159248 DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE Official recall number · Z-0516-2018 Nonconforming Material/Component
device-recall:cfres:161076 Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices). Official recall number · Z-0589-2018 Process design
device-recall:cfres:160371 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM Official recall number · Z-0455-2018 Process change control
device-recall:cfres:160527 bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications. Official recall number · Z-0503-2018 Process control
device-recall:cfres:160409 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM Official recall number · Z-0479-2018 Process change control
device-recall:cfres:161314 BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals. Official recall number · Z-0511-2018 Under Investigation by firm
device-recall:cfres:160334 Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM Official recall number · Z-0440-2018 Process change control
device-recall:cfres:160823 Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. Official recall number · Z-0506-2018 Labeling mix-ups
device-recall:cfres:149849 Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0246-2017 Unknown/Undetermined by firm
device-recall:cfres:149494 LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. Official recall number · Z-0093-2017 Device Design
device-recall:cfres:149757 General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0194-2017 Unknown/Undetermined by firm
device-recall:cfres:149704 Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0175-2017 Unknown/Undetermined by firm
device-recall:cfres:149823 Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0230-2017 Unknown/Undetermined by firm
device-recall:cfres:148779 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. Official recall number · Z-0120-2017 Other
device-recall:cfres:149706 Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0177-2017 Unknown/Undetermined by firm
device-recall:cfres:148418 CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures Official recall number · Z-0135-2017 Under Investigation by firm
device-recall:cfres:149794 CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen Official recall number · Z-0128-2017 Under Investigation by firm
device-recall:cfres:149527 enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods). Official recall number · Z-0300-2017 Software design
device-recall:cfres:149932 Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room Official recall number · Z-0282-2017 Unknown/Undetermined by firm

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