Category

Surgical Devices Recalls

3,817 surgical devices recalls on record from CPSC, FDA, and USDA.

3,817 recalls
High RiskFDA
Intuitive Surgical, Inc.
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral S...
Surgical Devices·1,374 affected·Jan 24, 2013
High RiskFDA
Bard Peripheral Vascular Inc
MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered ti...
Surgical Devices·17 affected·Jan 23, 2013
High RiskFDA
Bard Peripheral Vascular Inc
USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; ...
Surgical Devices·223 affected·Jan 23, 2013
High RiskFDA
Aesculap, Inc.
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Surgical Devices·59 affected·Jan 18, 2013
High RiskFDA
Greatbatch Medical
45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164...
Surgical Devices·913 affected·Jan 16, 2013
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary...
Surgical Devices·387 affected·Jan 16, 2013
High RiskFDA
Extremity Medical Llc
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained i...
Surgical Devices·238 affected·Jan 10, 2013
High RiskFDA
Photomedex, Inc.
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyro...
Surgical Devices·549 affected·Jan 4, 2013
CriticalFDA
Lumenis Limited
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcell...
Surgical Devices·931 affected·Jan 2, 2013
High RiskFDA
Conmed Corporation
UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- ...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 139110EXT, Single Use, Sterile, Rx ONLY ...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 139112, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electr...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Stryker Spine
Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Pol...
Surgical Devices·46 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Elect...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 60-7524-001, Sterile, Rx ONLY -- CONMED CORPORATION El...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 139104EXT, Single Use, Sterile, Rx ONLY ...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7521-001, Sterile, Rx ONLY...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY ...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED COR...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Conmed Corporation
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CO...
Surgical Devices·313,190 affected·Dec 27, 2012
High RiskFDA
Healthtronics, Inc.
HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCar...
Surgical Devices·50 affected·Dec 20, 2012
High RiskFDA
Carefusion 303 Inc
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted ...
Surgical Devices·5,050 affected·Dec 20, 2012
High RiskFDA
Concentric Medical Inc
FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&...
Surgical Devices·13 affected·Dec 20, 2012
High RiskFDA
Leica Microsystems (schweiz) Ag
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied ...
Surgical Devices·28 affected·Dec 18, 2012
High RiskFDA
Cardinal Health
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) ...
Surgical Devices·4 affected·Dec 18, 2012
High RiskFDA
Leica Microsystems (schweiz) Ag
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied ...
Surgical Devices·5 affected·Dec 18, 2012
High RiskFDA
Cardinal Health
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Ca...
Surgical Devices·4 affected·Dec 18, 2012
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patient...
Surgical Devices·1,004 affected·Dec 18, 2012
High RiskFDA
Cardinal Health
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) ...
Surgical Devices·3 affected·Dec 18, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally I...
Surgical Devices·210 affected·Dec 17, 2012
High RiskFDA
Arrow International Inc
Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilize...
Surgical Devices·188 affected·Nov 27, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Surgical Devices·8 affected·Nov 15, 2012
High RiskFDA
Medtronic Navigation, Inc.
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill ...
Surgical Devices·12 affected·Nov 13, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product ...
Surgical Devices·12 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage:...
Surgical Devices·69 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: ...
Surgical Devices·414 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 ...
Surgical Devices·411 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: ...
Surgical Devices·7 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage:...
Surgical Devices·27 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Produc...
Surgical Devices·35 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 ...
Surgical Devices·155 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: ...
Surgical Devices·5 affected·Nov 10, 2012
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage:...
Surgical Devices·17 affected·Nov 10, 2012
CriticalFDA
Stryker Howmedica Osteonics Corp.
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumen...
Surgical Devices·7,868 affected·Nov 8, 2012
High RiskFDA
Quanta System, S.p.a.
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular les...
Surgical Devices·12 affected·Nov 7, 2012
High RiskFDA
Quanta System, S.p.a.
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vasc...
Surgical Devices·22 affected·Nov 7, 2012
High RiskFDA
Omniguide, Inc.
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, a...
Surgical Devices·45 affected·Nov 5, 2012