Needle, Aspiration And Injection, Disposable
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
1,796 adverse event reports on file
- MedlineJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-08092
- BD Blunt Fill Needle 18g x 1.5"Jul 30, 2026OtherMW6000080
- Not ApplicableJul 29, 2026MalfunctionBd Medical (bd West) Medical Surgical1911916-2026-00391
- Vented NeedleJul 28, 2026MalfunctionB. Braun Medical Inc.2521402-2026-00734
- NEEDLE 18X1IN BLUNT FILLJul 27, 2026MalfunctionBd Medical (bd West) Medical Surgical1911916-2026-00385
- NEEDLE FILTER 19X1-1/2 TWJul 20, 2026MalfunctionBd Medical (bd West) Medical Surgical1911916-2026-00381
- NEEDLE 18X1IN BLUNT FILLJul 16, 2026MalfunctionBd Medical (bd West) Medical Surgical1911916-2026-00379
- STERIFIX®Jul 16, 2026MalfunctionB. Braun Medical Inc.2521402-2026-00691
- NEEDLE FILTER BLUNT FILL 18X1Jul 8, 2026InjuryBd Medical (bd West) Medical Surgical1911916-2026-00373
- NEEDLE FILTER BLUNT FILL 18X1-1/2Jul 7, 2026InjuryBd Medical (bd West) Medical Surgical1911916-2026-00367
Event type breakdown
Recalls
36 recall events for this product code
- Tytek Medical IncTerminatedSep 19, 2023
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in p
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Z-2610-2023 · View FDA record ↗ - Tytek Medical IncTerminatedSep 19, 2023
TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Z-2611-2023 · View FDA record ↗ - Tytek Medical IncTerminatedSep 19, 2023
TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Z-2612-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0017-2023 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Transbronchial Aspiration Needle
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0018-2023 · View FDA record ↗ - Cadence Inc.TerminatedAug 10, 2015
Perfectum Tuberculin Glass Syringe, Non sterile
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Z-2364-2015 · View FDA record ↗ - Cadence Inc.TerminatedAug 10, 2015
Micro-Mate Tuberculin Glass Syringe, Non-sterile
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Z-2365-2015 · View FDA record ↗ - SpineNetTerminatedAug 27, 2013
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M).
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
Z-2107-2013 · View FDA record ↗ - Inrad, IncTerminatedFeb 8, 2011
Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI.
This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.
Z-1063-2011 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedOct 7, 2010
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106.
There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles
Z-0023-2011 · View FDA record ↗
Registered firms
360 firms currently registered for this product code
Isomedix Operations Inc.
CHESTER, NY, US
Rozer Sterilization Technology Shuyang Company Limited
Shuyang Jiangsu, CN
Joimax Gmbh
KARLSRUHE Baden-Wurttemberg, DE
Sol-kl (shanghai) Medical Products Company Limited
Shanghai, CN
Zhejiang Huanyi Sterilization Technology Co., Ltd
huzhou Zhejiang, CN
Veenak International Limited
BIRMINGHAM, GB
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Custom Tube Manufacturing Llc
Yangju-si Gyeonggi, KR
Telemed Systems
Northborough, MA, US
Argon Medical Devices, Inc.
WHEELING, IL, US
Pmt Corp.
CHANHASSEN, MN, US
Cardinal Health
Hazelwood, MO, US
Hantech Medical Device Co., Ltd.
Cixi Zhejiang, CN
Itm Industria De Tecnologias Medicas Ltda
CANOAS Rio Grande do Sul, BR
Adria Srl.
San Giovanni in Persiceto Bologna, IT
Jedmed Instrument Company
Saint Louis, MO, US
Hart Enterprises, Inc.
SPARTA, MI, US
Beaver-visitec International, Inc.
Ciudad Juarez Chihuahua, MX
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Paragon 28
Englewood, CO, US
Surgical Technologies, Inc.
ST. PAUL, MN, US
Anping Guardian Medical Equipment Co.,ltd
Hengshui Hebei, CN
Sterigenics U.s., Llc
Queensbury, NY, US
Avid Medical, Inc. A Medical Action Ind. Company 305
TOANO, VA, US
510(k) clearances
107 clearances for this product code
- Pneumeric, Inc.Mar 28, 2023
K223625 · CapnoSpot Pneumothorax Decompression Indicator
- Arvik Enterprises/ Mini Lap TechnologiesJun 15, 2011
K102274 · ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
- Diametrics Medical, Inc.Nov 16, 2001
K011586 · IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
- Ximed/Prosure/InjectxMar 1, 2000
K994151 · PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
- Ximed/Prosure/InjectxDec 11, 1998
K983200 · INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
- Medical Device Technologies, Inc.Jan 8, 1998
K974741 · MANAN ACCURA NEEDLE
- Radi Medical Systems ABSep 11, 1996
K962425 · BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
- Medical Device Technologies, Inc.Jul 19, 1996
K961959 · MD TECH BIOPSY SET FOR BONE AND BONE MARROW