Needle, Aspiration And Injection, Reusable
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
56 adverse event reports on file
- PILLINGFeb 25, 2026MalfunctionTeleflex Medical Llc24442361
- HAWKINS II FLEXSTRAND BLN 20GA X 12.5CMMay 13, 2025InjuryArgon Medical Devices0001625425-2025-01012
- HAWKINS II FLEXSTRAND BLN 20GA X 12.5CMMay 13, 2025InjuryArgon Medical Devices0001625425-2025-01013
- HAWKINS III FLEXSTRAND BLN 20GA X 12.5CMMay 9, 2025MalfunctionArgon Medical Devices0001625425-2025-01009
- ASPIRATING NEEDLE TIP 23GAJan 6, 2025MalfunctionTeleflex Medical3011137372-2025-00008
- ASPIRATING NEEDLE TIP 23GAJan 6, 2025MalfunctionTeleflex Medical3011137372-2025-00009
- ASPIRATING NEEDLE TIP 23GAJan 6, 2025InjuryTeleflex Medical3011137372-2025-00010
- MEDIASTINOSCOPY ASPIRATING NEEDLEDec 16, 2024MalfunctionTeleflex MedicalMW5163667
- ASPIRATION NEEDLENov 18, 2024InjuryAomori Olympus Co., Ltd.2429304-2024-0000462
- ASPIRATION NEEDLENov 18, 2024InjuryAomori Olympus Co., Ltd.9614641-2024-02095
Event type breakdown
Recalls
4 recall events for this product code
- Spiggle & Theis Mt GmbhOpen, ClassifiedAug 15, 2025
Injection needle, bayonet, Luer-Lock,
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Z-2331-2025 · View FDA record ↗ - Teleflex MedicalTerminatedMar 16, 2016
Pilling Modular Verres Body/Obturator, Product Code 140880
Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (Verres cannula with integral needle tip).
Z-1178-2016 · View FDA record ↗ - Medical Device Technologies, Inc.TerminatedJul 13, 2010
Angiotech Breast Localization Needles:
Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.
Z-2015-2010 · View FDA record ↗ - Remington Medical Inc.TerminatedMay 26, 2009
CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005.
Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.
Z-1417-2009 · View FDA record ↗
Registered firms
117 firms currently registered for this product code
Taurus Medizintechnik Gmbh
Fridingen an der Donau Baden-Wurttemberg, DE
My Medical Store Llc
Fort Lauderdale, FL, US
Hangzhou Endo Medical Instrument Co.,ltd
hangzhou Zhejiang, CN
Millennium Surgical Corp
Schaumburg, IL, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Allwin Medical Devices, Inc.
ANAHEIM, CA, US
Jedmed Instrument Company
Saint Louis, MO, US
Stephens Instruments, Inc
LEXINGTON, KY, US
Surgipros Llc
Palmetto, FL, US
Dufner Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Integra Microfrance Sas
SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
Asanus Medizintechnik Gmbh
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Hive International Pvt Ltd.
Sialkot Punjab, PK
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Pilotis Tech Llc
Brookhaven, GA, US
Hilbro International (pvt) Limited
SIALKOT Punjab, PK
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Med2b Ltd.
Kitzingen Bavaria, DE
Aesculap, Inc.
CENTER VALLEY, PA, US
Acheron Instruments (pvt.) Ltd.
LAHORE Punjab, PK
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Xinhua Surgical Instrument Co. Ltd.
ZIBO Shandong, CN
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Swengg Co
Sialkot Punjab, PK
Moeller Medical Gmbh
FULDA Hesse, DE
510(k) clearances
48 clearances for this product code
- Stemcor Systems, Inc.Sep 24, 2007
K071732 · MARROWMINER
- Bioaccess, Inc.Jun 3, 1997
K971114 · BIOACCESS MARROW HARVEST SYSTEM
- Baxter Healthcare CorpSep 22, 1995
K953082 · ILIAC CREST BONE MARROW ASPIRATION NEEDLE
- Bioaccess, Inc.Aug 7, 1995
K953064 · BIOACCESS MARROW HARVEST SYSTEM
- Gerard Medical, Inc.Jun 16, 1994
K936207 · ENDO-NEEDLE INSTRUMENT
- Symbiosis Corp.Jul 6, 1993
K930160 · ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE
- The Straumann Co.Dec 15, 1992
K923872 · BONE MARROW BIOPSY SYSTEM
- Bd Becton Dickinson Vacutainer Systems PreanalyticFeb 3, 1992
K915572 · BECTON DICKINSON MODIFIED MENGHINI NEEDLE