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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 1508 of 1581

Evidence Product Join Root cause
device-recall:cfres:160535 ESSENTIO EL DR Pacemaker Official recall number · Z-0371-2018 Device Design
device-recall:cfres:160812 ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems. Official recall number · Z-0386-2018 Employee error
device-recall:cfres:160564 BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females. Official recall number · Z-0394-2018 Use error
device-recall:cfres:160475 ACCOLADE MRI DR Pacemaker Official recall number · Z-0358-2018 Device Design
device-recall:cfres:160477 VALITUDE CRT-P Pacemaker Official recall number · Z-0360-2018 Device Design
device-recall:cfres:160913 Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation. Official recall number · Z-0538-2018 Error in labeling
device-recall:cfres:160053 TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. Official recall number · Z-0339-2018 Error in labeling
device-recall:cfres:159792 LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital. Official recall number · Z-0294-2018 Other
device-recall:cfres:160710 Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone. Official recall number · Z-0409-2018 Under Investigation by firm
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: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:160851 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. Viva S CRT-D DF4 (Product No. DTBB1D4) 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-0584-2018 Process design
device-recall:cfres:160300 Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM Official recall number · Z-0421-2018 Process change control
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: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

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