Guide, Needle, Surgical
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
227 adverse event reports on file
- GhiatasJul 31, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01979
- SERANOVA MICRO INFUSION SYSTEMJul 31, 2026InjuryZhengzhou Magique Huaer Biotech Co.,ltd.3033813891-2026-00001
- GhiatasJul 29, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01957
- DuaLokJul 27, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-01887
- MICRO NEEDLING THERAPY SYSTEMJun 1, 2026InjuryZhengzhou Magique Huaer Biotech Co., Ltd.MW5188807
- SERANOVA MICRO INFUSION SYSTEMJun 1, 2026InjuryZhengzhou Magique Huaer Biotech Co.,ltd.MW5188822
- APTUSMar 12, 2026InjuryMedartis Ag3003236702-2026-00004
- DUALOK LOCALIZATION WIREMar 5, 2026InjuryBard Peripheral Vascular, Inc.2020394-2026-00601
- ZIMMER AIR DERMATOMEFeb 10, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00135
- GHIATASFeb 9, 2026MalfunctionBard Peripheral Vascular, Inc.2020394-2026-00198
Event type breakdown
Recalls
20 recall events for this product code
- Advance Medical Designs, Inc.Open, ClassifiedSep 9, 2023
Procedural kits containing ultrasonic transmission gel, Item Numbers:
Ultrasound gel mislabeled with inappropriate use.
Z-2536-2023 · View FDA record ↗ - Advance Medical Designs, Inc.Open, ClassifiedSep 9, 2023
procedural kits containing ultrasonic transmission gel, Item Numbers:
Ultrasound gel mislabeled with inappropriate use.
Z-2537-2023 · View FDA record ↗ - Bard Peripheral Vascular IncTerminatedMay 2, 2017
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201
It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.
Z-1900-2017 · View FDA record ↗ - Hologic, IncTerminatedSep 8, 2016
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
Tip Breakage at the glue joint between the obturator body and tip
Z-2765-2016 · View FDA record ↗ - Hologic, IncTerminatedSep 8, 2016
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
Tip Breakage at the glue joint between the obturator body and tip
Z-2766-2016 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 3, 2016
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Z-1037-2016 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 3, 2016
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Z-1038-2016 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 3, 2016
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Z-1039-2016 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedMar 3, 2016
50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
Z-1040-2016 · View FDA record ↗ - Bard Peripheral Vascular IncTerminatedSep 16, 2014
Bard DuaLok Breast Lesion Localization Wire,
Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier.
Z-2648-2014 · View FDA record ↗
Registered firms
252 firms currently registered for this product code
Linvatec Corporation
LARGO, FL, US
Olive Branch Distribution Center
Olive Branch, MS, US
Pfau Medizinische Instrumente Gmbh
WANFRIED Hesse, DE
Turon Medtech Ab
Varberg Halland, SE
Oman Medical Beauty Manufacture Limited
Hong Kong, HK
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Avnet Global Solution Center
Chandler, AZ, US
Biomet Microfixation
Jacksonville, FL, US
Hebei Mita Technology Limited
Hong Kong, HK
Shanghai Dochem Industries Co., Ltd.
SHANGHAI, CN
Medacta International Sa
Rancate Ticino, CH
Y.jacobs Medical Inc.
Seongnam-si Gyeonggi, KR
Steripack Medical Poland Sp. Z O.o.
Jelcz-Laskowice Dolnoslaskie, PL
Ranfac Corp.
Avon, MA, US
Coastline De Mexico Sa De Cv
Tijuana Baja California, MX
Shenzhen Baolijie Technology Co.,ltd.
Shenzhen Guangdong, CN
Carefusion 2200, Inc.
Vernon Hills, IL, US
Beijing Tian Teng Cang Yue Trading Co., Ltd.
BEIJING, CN
Diligent Medical Services
SIALKOT Punjab, PK
Icecure Medical Ltd.
Caesarea Northern, IL
Daddy D Pro
Sialkot Punjab, PK
Orthopedic Sciences, Inc
Overland Park, KS, US
Steris Corporation
Saint Louis, MO, US
Sklar Corporation
Malvern, PA, US
510(k) clearances
28 clearances for this product code
- Needle Tech Products, Inc.Jul 23, 2003
K031173 · NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
- Global Medical Products, Ltd.May 26, 1995
K950311 · GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE
- United States Surgical, A Division of Tyco HealthcMar 15, 1995
K950007 · SURGICAL INSTRUMENT GUIDE
- Promex, Inc.Nov 22, 1994
K945124 · BREAST LESION LOCALIZATION NEEDLE
- Promedical , Ltd.Nov 4, 1994
K944942 · BREAST LESION LOCALIZATION NEEDLE
- Bauer Medical, Inc.Feb 22, 1994
K935538 · BAUER TEMNO COAXIAL NEEDLE
- Bip USA, Inc.Feb 17, 1994
K935457 · LOCALIZATION WIRE OR MARKER - SURGICAL
- Guardian Angel Products, Inc.Jul 13, 1993
K923840 · NEEDLE-GRABBER