Blade, Scalpel
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
970 adverse event reports on file
- BARD-PARKER SAFETYLOCK CARBON RIB-BACK BLADES SIZE 11, STERILEJul 15, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00077
- MEDLINEJul 14, 2026MalfunctionMedline Industries, Lp1417592-2026-04884
- MEDLINEJun 30, 2026MalfunctionMedline Industries, Lp1417592-2022-03549
- MEDLINEJun 11, 2026MalfunctionMedline Industries, Lp - Spt1423395-2026-00270
- MEDLINEMay 22, 2026MalfunctionMedline Industries, Lp1417592-2026-01714
- BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILEMay 19, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00050
- BARD-PARKER SAFETY SCALPEL SIZE 15, STERILEMay 14, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00045
- BARD-PARKER DISPOSABLE SCALPELS SIZE 11, NON-STERILEMay 14, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00046
- CARBON RIB-BACK BLADES SIZE 15, STERILEApr 22, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00040
- BARD-PARKER ® CARBON RIB-BACK BLADESApr 2, 2026MalfunctionAspen Surgical Products, Inc.24765747
Event type breakdown
Recalls
13 recall events for this product code
- Southmedic, Inc.Open, ClassifiedNov 23, 2022
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.
Z-0279-2023 · View FDA record ↗ - Aspen Surgical Puerto Rico Corp.TerminatedSep 8, 2016
Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464."
After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.
Z-2755-2016 · View FDA record ↗ - Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.TerminatedNov 5, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***"
Potential for bent tips.
Z-0201-2013 · View FDA record ↗ - Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.TerminatedNov 5, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***"
Potential for bent tips.
Z-0202-2013 · View FDA record ↗ - Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.TerminatedNov 5, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***"
Potential for bent tips.
Z-0203-2013 · View FDA record ↗ - Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.TerminatedNov 5, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***"
Potential for bent tips.
Z-0204-2013 · View FDA record ↗ - Merit Medical Systems, Inc.TerminatedDec 14, 2009
Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No SMS210 Used for cutting tissue in surgical and laboratory procedures.
Potential sterility breach caused by excessive shipment damage.
Z-0522-2010 · View FDA record ↗ - Miltex, Inc.TerminatedFeb 20, 2009
Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.
Blade may break: Over milling of the blade resulted in tip more narrow than specified.
Z-0862-2009 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedOct 2, 2007
Shelf Pack:
Complaints received of rust on the blades of BD Bard-Parker Surgical blades.
Z-0012-2008 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedOct 2, 2007
Shelf Pack:
Complaints received of rust on the blades of BD Bard-Parker Surgical blades.
Z-0013-2008 · View FDA record ↗
Registered firms
308 firms currently registered for this product code
Surgical Design, Inc.
LORTON, VA, US
Geister Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Olulo Llc
Mc Lean, VA, US
Muto Pure Chemicals Co., Ltd.
Tokyo, JP
Ag Marketing & Development Group Inc Dba Agmd Group
Brampton Ontario, CA
Cancer Diagnostics, Inc.
Durham, NC, US
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
Sterigenics U.s., Llc
Queensbury, NY, US
Br Surgical Llc
Jacksonville, FL, US
Isomedix Operations, Inc.
Libertyville, IL, US
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Jai Surgicals Ltd.
ALWAR Rajasthan, IN
Mani, Inc. (head Office)
UTSUNOMIYA Tochigi, JP
Daddy D Pro
Sialkot Punjab, PK
Sinapi Biomedical (pty) Ltd
Stellenbosch Western Cape, ZA
Anhui Medpurest Medical Technology Co.,ltd
Anqing Anhui, CN
Novo Surgical, Inc.
Westmont, IL, US
Cardinal Health 200, Llc
Waukegan, IL, US
Synergy Sterilisation Rawang (m) Sdn. Bhd.
Rawang Selangor, MY
Valentine Intl. Ltd.
HSICHIH CITY, TAIPEI HSIEN, TW
Arch Medical Solutions - Memphis
BARTLETT, TN, US
Surgical Specialties Mexico S De Rl De Cv
Tijuana Baja California, MX
Med2b Ltd.
Kitzingen Bavaria, DE
Jay-med
SIALKOT Punjab, PK
Mrimed Inc. Dba: Quality Safety Tools
Petaluma, CA, US
510(k) clearances
48 clearances for this product code
- Omi Manufacturing Pty., Ltd.Sep 23, 2003
K032242 · PERSONNA PLUS SAFETY SCALPEL SYSTEM
- Devon Industries, Inc.Aug 18, 1993
K932998 · EASY-ON
- Innovative Surgical Technology, Inc.Feb 18, 1993
K923170 · LOS ALAMOS RETRACTABLE KNIFE
- Intergrated Visual, Inc.May 5, 1992
K915119 · SCALPEL BLADE REMOVER (BLADEGARD)
- Bd Becton Dickinson Vacutainer Systems PreanalyticMay 13, 1991
K911913 · PRECISION GLIDE - ENHANCED SURGICAL BLADE
- Rahn LaboratoriesMar 1, 1990
K900266 · STERILE CARBON STEEL SURGICAL BLADE
- Anchor Products Co.Dec 27, 1988
K884862 · ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
- Far East Intl. Trading Corp.Jun 15, 1988
K881638 · SURGICAL BLADE