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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 1580 of 1581

Evidence Product Join Root cause
device-recall:cfres:157835 Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence Official recall number · Z-2760-2017 Radiation Control for Health and Safety Act
device-recall:cfres:174622 YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control Official recall number · Z-2106-2019 Radiation Control for Health and Safety Act
device-recall:cfres:176369 ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement. Official recall number · Z-0521-2020 Environmental control
device-recall:cfres:174659 CTSTM Essential 8 Medium Official recall number · Z-0275-2020 Vendor change control
device-recall:cfres:181249 therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 Official recall number · Z-2290-2020 Under Investigation by firm
device-recall:cfres:189599 Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle Official recall number · Z-0223-2022 Nonconforming Material/Component
device-recall:cfres:187934 Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording. Official recall number · Z-2070-2021 No Marketing Application
device-recall:cfres:186830 REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Official recall number · Z-1586-2021 Component design/selection
device-recall:cfres:184203 v|tome|x L Series non-destructive testing cabinet x-ray systems Official recall number · Z-0442-2021 Radiation Control for Health and Safety Act
device-recall:cfres:181608 MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. Official recall number · Z-0518-2021 Nonconforming Material/Component
device-recall:cfres:182570 Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells. Official recall number · Z-2977-2020 Labeling False and Misleading
device-recall:cfres:207651 Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD Official recall number · Z-1815-2024 Radiation Control for Health and Safety Act
device-recall:cfres:196079 The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range. Official recall number · Z-0003-2023 Radiation Control for Health and Safety Act
device-recall:cfres:175260 ClubMax Laser Projection Series Official recall number · Z-2092-2019 Radiation Control for Health and Safety Act
device-recall:cfres:181102 Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225. Official recall number · Z-1727-2020 Radiation Control for Health and Safety Act
device-recall:cfres:173299 TASE 500 Imaging systems Official recall number · Z-1784-2019 Radiation Control for Health and Safety Act
device-recall:cfres:192629 Virus Counter Platform with Model Name VC3100 Official recall number · Z-0946-2022 Radiation Control for Health and Safety Act
device-recall:cfres:208478 HORIBA custom configured fluorescence instrument, modular Fluorolog-QM Official recall number · Z-2166-2024 Radiation Control for Health and Safety Act
device-recall:cfres:127241 CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment. Official recall number · Z-1709-2014 Software design
device-recall:cfres:214301 Ami HTX. Official recall number · Z-1942-2025 Radiation Control for Health and Safety Act
device-recall:cfres:155264 VITEK¿ 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards per carton. Official recall number · Z-2471-2017 Packaging
device-recall:cfres:155078 VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton. Official recall number · Z-2362-2017 Packaging
device-recall:cfres:155152 VITEK¿ 2 Gram Negative Susceptibility card (AST-N233), REF 413117, 20 cards per carton. Official recall number · Z-2404-2017 Packaging
device-recall:cfres:155221 VITEK¿ 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton. Official recall number · Z-2447-2017 Packaging
device-recall:cfres:155367 VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per carton. Official recall number · Z-2521-2017 Packaging