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Recall Observatory FDA recall evidence

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Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1529 of 1581

Evidence Product Join Root cause
device-recall:cfres:178138 Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 Official recall number · Z-0935-2020 Nonconforming Material/Component
device-recall:cfres:178089 GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. Official recall number · Z-0910-2020 Labeling mix-ups
device-recall:cfres:178698 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Official recall number · Z-0881-2020 Under Investigation by firm
device-recall:cfres:178427 ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring)) Official recall number · Z-0921-2020 Nonconforming Material/Component
device-recall:cfres:177530 CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. Official recall number · Z-0889-2020 Device Design
device-recall:cfres:178147 JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit. Official recall number · Z-0898-2020 Device Design
device-recall:cfres:179925 FlipCutter III Drill Official recall number · Z-1542-2020 Packaging process control
device-recall:cfres:180062 Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm Official recall number · Z-1533-2020 Labeling mix-ups
device-recall:cfres:179974 Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. Official recall number · Z-1519-2020 Other
device-recall:cfres:180229 Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. Official recall number · Z-1600-2020 No Marketing Application
device-recall:cfres:177897 D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. Official recall number · Z-1503-2020 Nonconforming Material/Component
device-recall:cfres:179954 Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista¿ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease. Official recall number · Z-1541-2020 Under Investigation by firm
device-recall:cfres:179950 Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus). Official recall number · Z-1537-2020 Under Investigation by firm
device-recall:cfres:180037 Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022. Official recall number · Z-1544-2020 Packaging
device-recall:cfres:179694 Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT. Official recall number · Z-1524-2020 Software design
device-recall:cfres:179902 NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0) Official recall number · Z-1554-2020 Software Manufacturing/Software Deployment
device-recall:cfres:172505 Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620 Official recall number · Z-1572-2019 Device Design
device-recall:cfres:172419 Maquet Getinge-BEQ-TOP 4901 Material: 701050839 Official recall number · Z-1510-2019 Device Design
device-recall:cfres:172304 Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216 Official recall number · Z-1472-2019 Under Investigation by firm
device-recall:cfres:171907 Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console. Official recall number · Z-1257-2019 Device Design
device-recall:cfres:172576 Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis. Official recall number · Z-1340-2019 Software design
device-recall:cfres:172126 MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S Official recall number · Z-1346-2019 Device Design
device-recall:cfres:171953 ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood. Official recall number · Z-1356-2019 Under Investigation by firm
device-recall:cfres:171952 ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood. Official recall number · Z-1355-2019 Under Investigation by firm
device-recall:cfres:171021 Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer. Official recall number · Z-1354-2019 Under Investigation by firm

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