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Sources: EU EUDAMED, US FDA
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Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·September 2, 2025
Artegraft Collagen Vascular Graft; REF: AG1015;
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·September 25, 2025
Artegraft Vascular Graft; REF#: AG740;
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·February 10, 2026
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
FDA Recall
Open, Classified
·LeMaitre Vascular, Inc.·Product code LXA·August 25, 2025
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·July 21, 2021
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·October 20, 2015
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA Recall
Open, Classified
·Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany·Product code JJE·June 2, 2023
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA Recall
Open, Classified
·Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany·Product code JJE·June 2, 2023
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
FDA Recall
Terminated
·Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munich Germany·Product code JJE·June 17, 2020
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."
FDA Recall
Terminated
·Ameditech Inc·Product code DIO·August 18, 2020
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·September 10, 2010
IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011
Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011