Boston Scientific Corporation - AURIGA 30 GENERAL SYSTEM - Class 2 Recall
AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA 30 BRAZIL SYSTEM - Class 2 Recall
AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - AURIGA XL 4007 BRAZIL SYSTEM - Class 2 Recall
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2019 Category: Medical Devices Source Type: alerts
Dornier Medtech America, Inc. - Class 2 Recall
Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K2012439 600 micron 5X reusable fiber K2010667 micron ITT fiber K2012875 600 micron 3X reusable fiber K2010710 400 micron single use fib...
Source: Medical Device Recalls - May 22, 2019 Category: Medical Devices Source Type: alerts
Matrix Surgical Holdings, LLC - OmniPore Surgical Implants - Class 2 Recall
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2019 Category: Medical Devices Source Type: alerts
Matrix Surgical Holdings, LLC - OmniPore Surgical ImplantsRight - Class 2 Recall
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2019 Category: Medical Devices Source Type: alerts
Beaver Visitec - Beaver AccuTemp High Temperature Cautery, 2 inch Shaft with Fine Tip - Class 2 Recall
Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include ophthalmic, general and plastic surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 14, 2018 Category: Medical Devices Source Type: alerts
Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase¿ Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial...
Source: Medical Device Recalls - July 20, 2018 Category: Medical Devices Source Type: alerts
Mentor Texas, LP. - SalineFilled SPECTRUM Breast Implants - Class 2 Recall
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 12, 2017 Category: Medical Devices Source Type: alerts
Mizuho OSI - 216 Wilson Frame Pads, Model 531937 - Class 2 Recall
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2017 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - da Vinci Xi EndoWrist Suction Irrigator - Class 2 Recall
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2017 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit - Class 2 Recall
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Finnish SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic). (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2017 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit - Class 2 Recall
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Norwegian SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic). (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2017 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit - Class 2 Recall
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Italian SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic). (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2017 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit - Class 2 Recall
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Korean SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci¿ Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic). (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 6, 2017 Category: Medical Equipment Source Type: alerts
