Forceps, Biopsy, Non-electric
Gastroenterology, Urology · 21 CFR 876.1075
Recent MDR events
2,705 adverse event reports on file
- RADIAL JAW 4Jul 22, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03001
- RADIAL JAW 4Jul 22, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03005
- SINGLE-USE BIOPSY FORCEPS (EYEMAX¿)Jul 21, 2026MalfunctionMicro-tech (nanjing) Co., Ltd.MW5190930
- Radial Jaw Large Capacity with NeedleJul 17, 2026OtherMW6000016
- BIGOPSY BACKLOADING BIOPSY FORCEPSJul 10, 2026MalfunctionCook Ireland Ltd.3001845648-2026-00271
- SINGLE-USE BIOPSY FORCEPJul 6, 2026MalfunctionMicro-tech (nanjing) Co.,ltd.3004837686-2026-00005
- MICRO-TECH FORCEPSJun 15, 2026InjuryMicro-tech (nanjing) Co., Ltd.MW5189445
- SPYBITE MAXJun 2, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02275
- BIGOPSY BACKLOADING BIOPSY FORCEPSMay 28, 2026MalfunctionCook Ireland Ltd3001845648-2026-00206
- GUIDE WIRE TYPE BIOPSY FORCEPSMay 20, 2026MalfunctionAomori Olympus Co., Ltd.9614641-2026-00524
Event type breakdown
Recalls
11 recall events for this product code
- Boston Scientific CorporationOpen, ClassifiedJul 31, 2026
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:
Potential for breach in sterile barrier of device packaging.
Z-2838-2026 · View FDA record ↗ - Boston Scientific CorporationOpen, ClassifiedJul 31, 2026
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN:
Potential for breach in sterile barrier of device packaging.
Z-2839-2026 · View FDA record ↗ - Boston Scientific CorporationOpen, ClassifiedJul 31, 2026
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN:
Potential for breach in sterile barrier of device packaging.
Z-2840-2026 · View FDA record ↗ - Richard Wolf GmbHOpen, ClassifiedApr 24, 2023
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
Z-1422-2023 · View FDA record ↗ - Richard Wolf GmbHOpen, ClassifiedApr 24, 2023
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
Z-1423-2023 · View FDA record ↗ - Richard Wolf GmbHOpen, ClassifiedApr 24, 2023
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
Z-1424-2023 · View FDA record ↗ - Richard Wolf GmbHOpen, ClassifiedApr 24, 2023
FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
Z-1425-2023 · View FDA record ↗ - Cook Inc.TerminatedAug 22, 2016
Transluminal Biliary Biopsy Forceps Set
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Z-2622-2016 · View FDA record ↗ - Boston Scientific CorporationTerminatedJun 4, 2010
Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
Z-1772-2010 · View FDA record ↗ - Boston Scientific CorporationTerminatedJun 4, 2010
Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.
Z-1773-2010 · View FDA record ↗
Registered firms
204 firms currently registered for this product code
Centerpoint Systems Llc
West Valley City, UT, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Sensorendo Medical Technology (zhuhai) Co., Ltd.
Zhuhai Guangdong, CN
Med2b Ltd.
Kitzingen Bavaria, DE
Boston Scientific Corporation
Coventry, RI, US
Volgo Care International (private) Limited
Sialkot Punjab, PK
Zhuji Pengtian Medical Instrument Co.,ltd.
Zhuji Zhejiang, CN
Alton Shanghai Medical Instruments Co Ltd
Shanghai, CN
Allwin Medical Devices, Inc.
ANAHEIM, CA, US
Technimen Skillers
SIALKOT Punjab, PK
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Electron Beam Sdn Bhd
Port Klang Selangor, MY
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Yangzhou Jiangsu, CN
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Trokamed Gmbh
GEISINGEN Baden-Wurttemberg, DE
Denzel Medical Gmbh & Co. Kg
NEUHAUSEN Baden-Wurttemberg, DE
Sterigenics U.s., Llc
Charlotte, NC, US
Zain's Medical Image
SIALKOT Punjab, PK
Aomori Olympus Co., Ltd. Kuroishi Site
KUROISHI-SHI Aomori, JP
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Wuxi Goals Medical Technology Co., Ltd.
Yixing Jiangsu, CN
Changzhou 3r Medical Device Technology Co., Ltd.
Changzhou Jiangsu, CN
Teleflex Medical Llc
Morrisville, NC, US
Acheron Instruments (pvt.) Ltd.
LAHORE Punjab, PK
510(k) clearances
39 clearances for this product code
- Olympus Optical Co., Ltd.Jul 16, 2003
K032092 · OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
- Spectrascience, Inc.Dec 2, 1997
K973611 · SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
- Richard Wolf Medical Instruments Corp.Sep 15, 1997
K971315 · AUXILIARY INSTRUMENTS FOR URS
- Robert J. Jynch, Jr.Dec 30, 1996
K964120 · INJECTO FLUSH
- Spectrascience, Inc.Dec 2, 1996
K963517 · SPECTRA SCIENCE BIOPSY FORCEPS
- Olympus America, Inc.Jan 24, 1996
K955065 · OLYMPUS FB SERIES BIOPSY FORCEPS
- Annex Medical, Inc.Jul 19, 1995
K952863 · FORCEPS, BIOPSY, NON-ELECTRIC
- Portlyn Corp.Jun 1, 1995
K952391 · DYNABITE UROLOGICAL FORCEPS