Handle, Scalpel
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
128 adverse event reports on file
- KONIGJul 22, 2026InjuryMedline Industries, Lp1417592-2026-07290
- KONIGJul 21, 2026InjuryMedline Industries, Lp1417592-2026-07445
- SCALPEL HANDLE #3 125MMJul 16, 2026InjuryAesculap Ag9610612-2026-00149
- #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, NSJun 25, 2026MalfunctionDeroyal Industries, Inc.1123071-2026-00001
- LONG SCALPEL HANDLEJun 22, 2026MalfunctionSynthes Gmbh8030965-2026-06421
- LONG SCALPEL HANDLEJun 19, 2026MalfunctionSynthes Gmbh8030965-2026-06394
- LONG SCALPEL HANDLEMay 6, 2026MalfunctionSynthes Gmbh8030965-2026-04300
- LARGE CANNULATED HANDLE W/ QUICK COUPLING - 12MM HEXMay 4, 2026MalfunctionSynthes Gmbh8030965-2026-04159
- LARGE CANNULATED HANDLE W/ QUICK COUPLING - 12MM HEXMay 4, 2026MalfunctionSynthes Gmbh8030965-2026-04160
- LONG SCALPEL HANDLEMay 1, 2026MalfunctionSynthes Gmbh8030965-2026-04147
Event type breakdown
Recalls
13 recall events for this product code
- Sklar InstrumentsOpen, ClassifiedJan 16, 2025
ECONO STERILE medical procedure kits labeled as:
Reports of various packaging issues that may result in a breach of the sterile barrier.
Z-0937-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMar 29, 2024
Centurion scalpel handle kits labeled as:
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Z-1436-2024 · View FDA record ↗ - Steris CorporationTerminatedOct 12, 2022
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.
Z-0079-2023 · View FDA record ↗ - Teleflex MedicalCompletedOct 16, 2017
Pilling Knife Handles:
The knife handles slot depth is out of specification, so blades may not fit on the handles properly.
Z-0039-2018 · View FDA record ↗ - Integra York PA, IncTerminatedMay 31, 2016
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
Z-1841-2016 · View FDA record ↗ - Bard Access SystemsTerminatedApr 14, 2015
Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
Potential for inadvertent scalpel stick injury involving the safety scalpel.
Z-1443-2015 · View FDA record ↗ - Ansell Sandel Medical Industries LLCTerminatedJan 8, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade
Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
Z-0635-2014 · View FDA record ↗ - Ansell Sandel Medical Industries LLCTerminatedJan 8, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade
Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
Z-0636-2014 · View FDA record ↗ - Ansell Sandel Medical Industries LLCTerminatedJan 8, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade
Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
Z-0637-2014 · View FDA record ↗ - Ansell Sandel Medical Industries LLCTerminatedJan 8, 2014
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade
Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
Z-0638-2014 · View FDA record ↗
Registered firms
444 firms currently registered for this product code
Endo Tech Instruments
Sialkot Punjab, PK
Vehu Medical Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Rebstock Instruments Gmbh
DUERBHEIM Baden-Wurttemberg, DE
Beaver-visitec International, Ltd
BIDFORD-ON-AVON Warwickshire, GB
Kls Martin Malaysia Sdn. Bhd.
Simpang Ampat Pulau Pinang, MY
Shriram Institute For Industrial Research
Delhi, IN
Sterilization Services Of Virginia
RICHMOND, VA, US
Biopsy Fine Cut Instruments
Sialkot Punjab, PK
Gsource, Llc.
EMERSON, NJ, US
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Teleflex Medical Llc
Morrisville, NC, US
Kapp Surgical Instrument, Inc.
Bedford Heights, OH, US
Pms Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Oertel Medical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Rumex International Co.
Tampa, FL, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Eisenhut Instrumente Gmbh
FRITTLINGEN Baden-Wurttemberg, DE
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Shanghai Wilpower Industrial Co., Ltd
Shanghai, CN
Darleys Surgical Co.
SIALKOT, PUNJAB, PK
Sabri Industries
SIALKOT Punjab, PK
Hayden Medical Inc
Valencia, CA, US
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
510(k) clearances
16 clearances for this product code
- Spectra, Inc.Dec 15, 2009
K091462 · SPECTRA MEDICAL SAFETY SCAPEL
- Kinetic Medical ProductsJan 27, 1989
K890242 · SCALPEL HANDLE
- Bd Becton Dickinson Vacutainer Systems PreanalyticNov 17, 1988
K884512 · BEAVER(R) HANDLE
- Precision Surgical Industries, Inc.Oct 24, 1986
K863951 · P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
- S. Cordero Co.Oct 14, 1986
K863808 · THE S. CORDERO STYLUS
- Keisei Medical Industrial Co., Ltd.Sep 2, 1986
K863212 · KEISEI HANDLES FOR SURGICAL BLADES
- Medelec Intl. Corp.Dec 24, 1985
K854858 · SCALPEL HANDLE
- The Huxley Instrument Corp.Jul 15, 1985
K852735 · SCALPEL HANDLE #7 SS 410 OR 420