BEUDAMED
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    Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40

    FDA Recall
    Open, Classified ·Contego Medical LLC·Product code NIM·September 4, 2025

    Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code NIM·March 19, 2009

    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code GIM·July 2, 2012

    ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

    FDA Recall
    Terminated ·Product code NIM·December 4, 2014

    Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code NIM·March 19, 2009

    Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code KIM·September 4, 2018

    CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIM·September 10, 2010

    RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIM·September 10, 2010

    CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

    FDA Recall
    Open, Classified ·INSPIREMD Inc·Product code NIM·May 1, 2026

    BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood collection set.

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code GIM·March 5, 2012

    Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in a catheter tip and originates proximally in a luer hub designed to accept a 0.018 guidewire. The delivery systems have a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the space between the inner shaft and the outer sheath, located between distal and proximal stent makers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2mm smaller in diameter than the unconstrained diameter of the stent.

    FDA Recall
    Open, Classified ·Cardinal Health Inc.·Product code NIM·November 14, 2019

    ENROUTE Transcarotid Stent System REF SR-XXYY-CS

    FDA Recall
    Terminated ·Silk Road Medical Inc·Product code NIM·January 13, 2021

    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code GIM·August 8, 2025

    ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

    FDA Recall
    Terminated ·Product code NIM·December 4, 2014

    Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code NIM·May 1, 2007

    Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.

    FDA Recall
    Open, Classified ·Streck·Product code GIM·February 23, 2017

    VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code GIM·March 29, 2021

    PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC

    FDA Recall
    Completed ·Cordis Corporation·Product code NIM·February 11, 2021