Biopsy Needle
Gastroenterology, Urology · 21 CFR 876.1075
Recent MDR events
4,892 adverse event reports on file
- ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLEJul 29, 2026MalfunctionCook Ireland Ltd3001845648-2026-00305
- ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLEJul 29, 2026MalfunctionCook Ireland Ltd3001845648-2026-00306
- ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLEJul 29, 2026InjuryCook Ireland Ltd3001845648-2026-00307
- Magnum NeedleJul 29, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01956
- Single Use Aspiration Needle NA-U401SXJul 29, 2026MalfunctionGyrus Acmi, Inc.3011050570-2026-00767
- TruGuideJul 28, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01931
- TruGuideJul 28, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01929
- TruGuideJul 28, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01930
- TruGuideJul 28, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01932
- TruGuideJul 28, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01933
Event type breakdown
Recalls
54 recall events for this product code
- Bard Peripheral Vascular IncOpen, ClassifiedSep 20, 2024
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF:
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
Z-3206-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3003-2024 · View FDA record ↗ - Cook Medical IncorporatedOpen, ClassifiedMay 16, 2024
EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Devices may contain elevated levels of bacterial endotoxin.
Z-1832-2024 · View FDA record ↗ - Cook Medical IncorporatedOpen, ClassifiedMay 16, 2024
EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Devices may contain elevated levels of bacterial endotoxin.
Z-1833-2024 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedMay 19, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramu
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Z-1615-2023 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedMay 19, 2023
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and t
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Z-1616-2023 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1600-2022 · View FDA record ↗ - Covidien LlcOpen, ClassifiedAug 5, 2020
Beacon EUS Access System Preloaded Access 90degree Needle
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Z-2768-2020 · View FDA record ↗ - Covidien LlcOpen, ClassifiedAug 5, 2020
Beacon EUS Access System Preloaded Access 135degree Needle
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Z-2769-2020 · View FDA record ↗ - MedtronicTerminatedFeb 28, 2017
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
Handle may break during use.
Z-1472-2017 · View FDA record ↗
Registered firms
279 firms currently registered for this product code
Isomedix Operations Inc.
S Plainfield, NJ, US
M.d.l. S.r.l.
Delebio (So) Sondrio, IT
Boston Scientific Limited
GALWAY, IE
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Japan Gas Company Limited
YOKOHAMA Kanagawa, JP
Steris Ast Cz S.r.o.
VELKA BITES Vysocina, CZ
Finemedix
Daegu Gwangyeogsi, KR
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Boston Scientific Corporation
SPENCER, IN, US
Sterigenics U.s., Llc
Queensbury, NY, US
Medi-globe Sro
HRANICE Olomouc, CZ
Aomori Olympus Co., Ltd. Hirosaki Site
Hirosaki-shi Aomori, JP
Freudenberg Medical, Llc
Jeffersonville, IN, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Merit Medical Uk Limited
Earley Reading, GB
Sterilization Services Of Georgia, Inc.
ATLANTA, GA, US
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
C.r. Bard, Inc.
MADISON, GA, US
Ranfac Corp.
Avon, MA, US
Cbr Enterprise Limited
Hong Kong, HK
Carefusion 2200, Inc.
Vernon Hills, IL, US
Teleflex Llc (nadc)
Olive Branch, MS, US
510(k) clearances
133 clearances for this product code
- Olympus Medical Systems Corp.Oct 24, 2025
K252646 · Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- Finemedix Co., Ltd.Aug 21, 2025
K250994 · ClearTip FNA and FNB Types
- Cook Ireland, Ltd.Jul 29, 2024
K241209 · EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
- Limaca Medical, Ltd.Aug 28, 2023
K231422 · Precision GI
- Finemedix Co., Ltd.Jun 30, 2023
K231267 · ClearTip
- Cook Ireland, Ltd.May 30, 2023
K230909 · EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
- Bibbinstruments ABMar 29, 2023
K212423 · EndoDrill® Model X
- Suzhou Leapmed Healthcare CorporationJul 6, 2022
K212819 · Disposable Biopsy Refill Needle