Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
"***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*...
Surgical Devices·879 affected·Jun 26, 2012
High RiskFDA
Stryker Endoscopy
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distrib...
Surgical Devices·6,388 affected·Jun 19, 2012
High RiskFDA
Hill-rom, Inc.
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Surgical Devices·7,843 affected·Jun 18, 2012
High RiskFDA
Deroyal Industries Inc
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Surgical Devices·303 affected·Jun 16, 2012
High RiskFDA
Encision, Inc.
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosu...
Surgical Devices·48 affected·Jun 15, 2012
High RiskFDA
Tedan Surgical Innovations Llc
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products b...
Surgical Devices·12,065 affected·Jun 11, 2012
CriticalFDA
Stryker Instruments Div. Of Stryker Corporation
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and...
Surgical Devices·10,394 affected·Jun 8, 2012
CriticalFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use i...
Surgical Devices·1,075 affected·Jun 8, 2012
CriticalFDA
Stryker Instruments Div. Of Stryker Corporation
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Us...
Surgical Devices·5,925 affected·Jun 8, 2012
High RiskFDA
Psc Industries Inc
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Num...
Surgical Devices·50 affected·Jun 5, 2012
High RiskFDA
Psc Industries Inc
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304...
Surgical Devices·725 affected·Jun 5, 2012
High RiskFDA
Zimmer, Inc.
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non steril...
Surgical Devices·249 affected·Jun 5, 2012
High RiskFDA
Aesculap, Inc.
Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Gui...
Surgical Devices·11 affected·Jun 4, 2012
High RiskFDA
Leica Microsystems, Inc.
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switz...
Surgical Devices·39 affected·Jun 4, 2012
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the ...
Surgical Devices·23,653 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656...
Surgical Devices·40 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgi...
Surgical Devices·7 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Ea...
Surgical Devices·125 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgi...
Surgical Devices·5 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. ...
Surgical Devices·80 affected·Jun 1, 2012
High RiskFDA
Trumpf Medical Systems, Inc.
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUM...
Surgical Devices·402 affected·May 29, 2012
High RiskFDA
Ekos Corporation
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-...
Surgical Devices·21,892 affected·May 24, 2012
High RiskFDA
Stingray Surgical Products, Llc
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Han...
Surgical Devices·6,326 affected·May 23, 2012
High RiskFDA
Invuity, Inc.
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. T...
Surgical Devices·197 affected·May 12, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwel...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled ...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwell...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain th...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled s...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain th...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled ...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the pa...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwell...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
CriticalFDA
Arrow International Inc
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen ...
Surgical Devices·634,912 affected·May 3, 2012
High RiskFDA
Intuitive Surgical, Inc.
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
Surgical Devices·2,606 affected·Apr 27, 2012
High RiskFDA
Osteotech Inc
Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tis...
Surgical Devices·9,533 affected·Apr 20, 2012
High RiskFDA
Osteotech Inc
Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with i...
Surgical Devices·37 affected·Apr 20, 2012
High RiskFDA
Osteotech Inc
Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combine...
Surgical Devices·4,117 affected·Apr 20, 2012
High RiskFDA
Osteotech Inc
Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with ...
Surgical Devices·3,541 affected·Apr 20, 2012
High RiskFDA
Bacterin International, Inc.
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Dat...
Surgical Devices·3 affected·Apr 18, 2012