Holder, Needle, Gastroenterologic
Gastroenterology, Urology · 21 CFR 876.4730
Recent MDR events
1,038 adverse event reports on file
- INTEGRA JARITJul 9, 2026MalfunctionIntegra Lifesciences Production Corporation25762383
- CAPIOMay 8, 2026MalfunctionBoston Scientific Corporation2124215-2026-25108
- NEEDLE HOLDERApr 21, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-00880
- CAPIOApr 15, 2026MalfunctionBoston Scientific Corporation2124215-2026-20506
- NEEDLE HOLDERMar 7, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-00486
- CAPIODec 9, 2025MalfunctionBoston Scientific Corporation2124215-2025-88644
- CAPIOJul 24, 2025MalfunctionBoston Scientific Corporation2124215-2025-49755
- CAPIOJul 16, 2025MalfunctionBoston Scientific Corporation2124215-2025-45468
- CAPIOJul 3, 2025MalfunctionBoston Scientific Corporation2124215-2025-41947
- ENDOPATH*REUSABLE NDL HOLDERJul 2, 2025MalfunctionEthicon Endo-surgery, Llc.3005075853-2025-05070
Event type breakdown
Recalls
4 recall events for this product code
- Davol, Inc., Sub. C. R. Bard, Inc.TerminatedSep 6, 2009
BARD Simpulse" SOLO System with Soft Splash Shield Tip
Product sterility may be compromised due to lack of package integrity.
Z-1948-2009 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages.
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Z-2313-2017 · View FDA record ↗ - Dufner Instrumente GmbHTerminatedUnknown
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures
Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
Z-2534-2020 · View FDA record ↗ - Boss Instruments, Ltd.TerminatedUnknown
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices inten
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Z-2767-2020 · View FDA record ↗
Registered firms
344 firms currently registered for this product code
Taurus Medizintechnik Gmbh
Fridingen an der Donau Baden-Wurttemberg, DE
Prais Reliable Dental Supplies S.a
Victoria Grand Anse Mahe, SC
Hangzhou Endo Medical Instrument Co.,ltd
hangzhou Zhejiang, CN
Richbolt Enterprises
SIALKOT Punjab, PK
Hnm Medical Dba Hnm Total Recon
Miami, FL, US
Itm Industria De Tecnologias Medicas Ltda
CANOAS Rio Grande do Sul, BR
Surgix Medical Llc
Spring, TX, US
Otto Leibinger Gmbh
MUEHLHEIM Baden-Wurttemberg, DE
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Pms Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Hayden Medical Inc
Valencia, CA, US
S.g. Manufacturers
Sialkot Punjab, PK
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Scanlan International, Inc.
Saint Paul, MN, US
S.u.a. Martin Gmbh & Co.
RIETHEIM-WEILHEIM Baden-Wurttemberg, DE
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Integra Lifesciences Production Corporation
Mansfield, MA, US
Madhi Corporation
Sialkot Punjab, PK
Sinntech Medical (private) Limited
Sialkot Punjab, PK
Kazan Medical Instruments Plant Joint Stock Compan
KAZAN Tatarstan, RU
K.t. Surgico
SIALKOT Punjab, PK
G.a. Surgical (pvt) Ltd.
SIALKOT Punjab, PK
M.m Dental Corp
Sialkot Punjab, PK
510(k) clearances
7 clearances for this product code
- Phx Technologies Corp.Jan 9, 1998
K974327 · WINGED NEEDLE HOLDER
- Nusurg, Inc.Jun 25, 1993
K924196 · LAPAROSCOPIC NEEDLE HOLDER
- Holmed Corp.Jun 8, 1993
K930330 · ENDOSCOPIC NEEDLEHOLDER, MODIFICATION
- RetraxMay 26, 1993
K920706 · MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
- ArtiberiaJun 20, 1985
K851779 · 25-100,25-220 VARIOUS NEEDLE HOLDERS
- ArtiberiaJun 20, 1985
K851780 · 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS
- Edward Weck, Inc.Oct 4, 1977
K771859 · NEEDLE HOLDER, MICROVASCULAR