111 results
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21ms
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Sources: EU EUDAMED, US FDA
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Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with ethylene oxide gas . UPN for inner pouch M001434500 Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FCG·October 7, 2008
Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN MOO1434521, Sterilized with ethylene oxide gas. UPN for inner pouch M001434520. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FCG·October 7, 2008
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
Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-107, REF M0065001070 and M0065001071. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
FDA Recall
Terminated
·Boston Scientific Corp·Product code FCG·October 17, 2008
Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-114, REF M0065001140 and M0065001141. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
FDA Recall
Terminated
·Boston Scientific Corp·Product code FCG·October 17, 2008
Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-106, REF M0065001060 and M0065001061. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
FDA Recall
Terminated
·Boston Scientific Corp·Product code FCG·October 17, 2008
Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum Disposable Biopsy Core Needle 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
Terminated
·Bard Peripheral Vascular Inc·Product code FCG·October 8, 2009
Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FCG·July 6, 2016
SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
FDA Recall
Terminated
·Medtronic·Product code FCG·February 8, 2017
NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
FDA Recall
Terminated
·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FCG·January 4, 2021
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
Neurotransmitters XL
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code CKG·November 3, 2025
Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FCG·October 20, 2010
Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-115, REF M0065001150 and M0065001151. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
FDA Recall
Terminated
·Boston Scientific Corp·Product code FCG·October 17, 2008
Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard Magnum Disposable Biopsy Core Needle 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
Terminated
·Bard Peripheral Vascular Inc·Product code FCG·October 8, 2009
Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard Magnum Disposable Biopsy Core Needle 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
Terminated
·Bard Peripheral Vascular Inc·Product code FCG·October 8, 2009
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
FDA Recall
Terminated
·Cook Inc.·Product code FCG·April 15, 2016
OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
FDA Recall
Terminated
·Olympus America Inc.·Product code FCG·August 25, 2011