678 results
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27ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
FDA Recall
Terminated
·Microline Surgical, Inc.·Product code GEI·July 13, 2017
Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory
FDA Recall
Terminated
·Xodus Medical Inc·Product code GEI·September 19, 2019
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code GEI·October 2, 2019
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·March 6, 2023
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.
FDA Recall
Open, Classified
·Kirwan Surgical Products, LLC·Product code GEI·November 14, 2024
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code GEI·March 10, 2025
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEI·March 23, 2026
Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GEI·November 16, 2007
Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.
FDA Recall
Terminated
·Gyrus ACMI Corporation·Product code GEI·August 18, 2009
E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.
FDA Recall
Terminated
·Megadyne Medical Products, Inc.·Product code GEI·October 13, 2009
Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery.
FDA Recall
Terminated
·Starion Instruments·Product code GEI·February 6, 2008
Mitek VAPR Flexible Side Effect Electrode (integrated) Product Code: 227312 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code GEI·June 7, 2010
Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9 and S ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code GEI·June 7, 2010
ABC Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label) ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 9" (22.8 cm) QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Case label) Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 18, 2008
RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
FDA Recall
Terminated
·Rita Medical Systems, Inc.·Product code GEI·April 3, 2007
Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
FDA Recall
Terminated
·Datascope Corporation·Product code GEI·May 7, 2007
ConMed Goldline Hand Controlled With Blade Electrode, Rocker Switch, Safety Holster and 15 FT Cable, REF 130327A, Sterile R, Assembled in Mexico, ConMed Corporation, 525 French Rd., Utica, NY 13502.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·March 29, 2010
Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers of Centurion Healthcare Products.
FDA Recall
Terminated
·Centurion Medical Products·Product code GEI·April 9, 2010
AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
FDA Recall
Terminated
·Encision, Inc.·Product code GEI·April 5, 2010
Button Switch Electrosurgical Pencil with Holster
FDA Recall
Terminated
·Megadyne Medical Products, Inc·Product code GEI·April 6, 2006