15 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the introduction of various types of pacing or defibrillator leads and catheters.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DYB·June 11, 2024
ASG-001; Ultrasound gel
FDA Recall
Open, Classified
·Advance Medical Designs, Inc.·Product code MUI·July 7, 2023
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DYB·June 11, 2024
VADER pedicle system, torque wrench, Catalog Number 42-703
FDA Recall
Open, Classified
·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023
VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
FDA Recall
Open, Classified
·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code NKB·November 3, 2022
VADER pedicle system, torque wrench, Catalog Number 42-702
FDA Recall
Open, Classified
·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FCG·March 31, 2023
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
FDA Recall
Open, Classified
·Covidien Llc·Product code FCG·June 26, 2020
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
FDA Recall
Open, Classified
·Covidien Llc·Product code FCG·June 26, 2020
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438·Product code FCG·August 2, 2024
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FCG·March 31, 2023
MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code FCG·May 25, 2022
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCG·April 8, 2024
EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
FDA Recall
Open, Classified
·Cook Medical Incorporated·Product code FCG·April 1, 2024
EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
FDA Recall
Open, Classified
·Cook Medical Incorporated·Product code FCG·April 1, 2024