Intuitive Surgical, Inc. - CURVEDTIP STAPLER 30,IS4000 - Class 2 Recall
CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads 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 is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - STAPLER,IS4000 - Class 2 Recall
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci 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 - August 27, 2016 Category: Medical Equipment Source Type: alerts
Cook Inc. - Kumpe Access Catheter - Class 2 Recall
Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire¿, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts
Mentor Texas, LP. - Mentor MemoryGel Breast Implant - Class 2 Recall
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 4, 2016 Category: Medical Equipment Source Type: alerts
Biomet, Inc. - Biomet Inc., Biomet Sports Medicine, and Biomet - Class 2 Recall
Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System (VCLAS) - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology. (Sou...
Source: Medical Device Recalls - May 17, 2016 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 2 Recall
Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Richard Wolf Medical Instruments Corp. - Richard Wolf Medical Istruments - Class 2 Recall
The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2016 Category: Medical Equipment Source Type: alerts
Richard Wolf Medical Instruments Corp. - Richard Wolf Medical Istruments - Class 2 Recall
The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2016 Category: Medical Equipment Source Type: alerts
Richard Wolf Medical Instruments Corp. - Richard Wolf Medical Istruments - Class 2 Recall
The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 10, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - 0 deg, 8mm Endoscope, IS4000 - Class 2 Recall
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - 30 deg, 8mm Endoscope, IS4000 - Class 2 Recall
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2016 Category: Medical Equipment Source Type: alerts
Synvasive Technology Inc - Zimmer Oscillating Flat - Class 2 Recall
Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2015 Category: Medical Equipment Source Type: alerts
Ceterix Orthopedics, Inc. - Suture cutter - Class 2 Recall
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 10, 2015 Category: Medical Equipment Source Type: alerts
Miramar Labs, Inc. - Class 2 Recall
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2015 Category: Medical Equipment Source Type: alerts
