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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 1572 of 1581

Evidence Product Join Root cause
device-recall:cfres:128130 ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790 Official recall number · Z-1991-2014 Nonconforming Material/Component
device-recall:cfres:128402 Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103. Official recall number · Z-2088-2014 Device Design
device-recall:cfres:127524 Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Official recall number · Z-2099-2014 Process control
device-recall:cfres:128482 Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing. Official recall number · Z-2115-2014 Packaging process control
device-recall:cfres:128577 Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier. Official recall number · Z-2108-2014 Nonconforming Material/Component
device-recall:cfres:128606 Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. Official recall number · Z-2119-2014 Other
device-recall:cfres:127538 Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family. Official recall number · Z-2023-2014 Device Design
device-recall:cfres:128391 GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Official recall number · Z-2037-2014 Software design
device-recall:cfres:127544 Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components. Official recall number · Z-2033-2014 Packaging
device-recall:cfres:127980 BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli. Official recall number · Z-2041-2014 Labeling mix-ups
device-recall:cfres:128235 Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products Official recall number · Z-2044-2014 Software design (manufacturing process)
device-recall:cfres:126863 Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 74466, 71317-02 72991-02, 74951, 74336, 74121-01, 72941-01, 73315-03, 74559, 74277, 71382-01, 73108-02, 74178-03, 71598-02, 73108-02, 74618-01, 70334-03, 74802-01, 74916, 71932-02, 70951-03, 73957-01, 74857-01, 70957-02, 73449-01, 73124, 71546-02, 72892-01, 74431, 72370, 73913-01, 73957-01, 75028, 71820-01, 74201, 74402, 73891-01, 73865, 73972, 71175-01, 73208-03, 72669-02, 70533-09, 72275-01, 74369, 74321-01, 73175, B73235, 74459, 73931, 74262-01, 71002-01, 74879-01, 71801-01, 72384, 74365, 74366, 74348-01, 72072-02, 74048, 70932-03, 73407, 74879-01, 73820-01, 74161-01, 72991-02, 73288-01, 70016, 70466-08, 70188-04, 72238-02, 72817-01, 71103-02, 71717-01, 70957-02, 70196-02, 73872-02, 71896-02, 73191-01, 70977-05, 73438, 73201-01, 74671, 70367-07, 73276-02, 74482-01, 73551-02, 71537, 74348-01, 73211-01, 74430, 72026-03, 74502, 74873, 73652-01, 74163-02, 71733-02, 70075-06, 72846, 73820-01, 75063, 74155-01, 74454-01, 73428-01, 73442-01, 70664-01, 70012-05, 70099-03, 70159-05, 70917, 72965-02, 73645-01, 74417, 73346, 74433, 74737, 73055-02, 70227-04, 70880-05, 71934-02, 72073-01, 72149-01, 74120-01, 72370, 73662-03, 74251, 73872-02, 70658-09, 74550, 74124, 74096-01, 74203, 70174-09, 71485-01, 71905-01, 73124, 73874, 74467-01, 8327TXC-08, 8365TXC-01, 8390TXC, 74433, and 74737. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures. Official recall number · Z-2030-2014 Device Design
device-recall:cfres:128438 The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures. Official recall number · Z-2026-2014 Device Design
device-recall:cfres:127716 Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones. Official recall number · Z-2127-2014 Process control
device-recall:cfres:128397 Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Official recall number · Z-2143-2014 Package design/selection
device-recall:cfres:128400 Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures. Official recall number · Z-2131-2014 Device Design
device-recall:cfres:128750 Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert. Official recall number · Z-2128-2014 Process design
device-recall:cfres:128151 RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use Official recall number · Z-1825-2014 Device Design
device-recall:cfres:127412 Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Official recall number · Z-1753-2014 Nonconforming Material/Component
device-recall:cfres:127289 Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. Official recall number · Z-1790-2014 Labeling design
device-recall:cfres:127432 Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis. Official recall number · Z-1771-2014 Nonconforming Material/Component
device-recall:cfres:127317 cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. Official recall number · Z-1792-2014 Labeling design
device-recall:cfres:127224 Synergy XVI Intended for radiation therapy treatment. Official recall number · Z-1724-2014 Software design
device-recall:cfres:127270 VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent. Official recall number · Z-1804-2014 Process change control
device-recall:cfres:127076 RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy. Official recall number · Z-1806-2014 Software design