25 results · 10ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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

Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FAD·July 29, 2022

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FAD·July 29, 2022

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426

FDA Recall
Open, Classified ·C.R. Bard Inc·Product code FAD·November 6, 2025

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

FDA Recall
Open, Classified ·C.R. Bard Inc·Product code FAD·November 6, 2025

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

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FAD·July 29, 2022

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

BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826

FDA Recall
Open, Classified ·C.R. Bard Inc·Product code FAD·November 6, 2025

Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code FAD·November 16, 2020

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FAD·July 29, 2022

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

Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.

FDA Recall
Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FCB·September 25, 2023

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FAD·July 29, 2022

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FAD·July 29, 2022

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004

FDA Recall
Open, Classified ·Hobbs Medical, Inc.·Product code FAD·July 29, 2022