96 results
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26ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord M426884 used with VAC ATS Canadian Model M8259994.
FDA Recall
Terminated
·KCI USA, Inc.·Product code OMP·November 4, 2009
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #M4268840 used with First Step All-In-One Canadian French Models 227500-09 and 227500, First Step All-In-One English Model 227500, Therakair Visio Models M8259978 and M6257763 pump only, and Proficare - Canada Model M8259988
FDA Recall
Terminated
·KCI USA, Inc.·Product code IKY·November 4, 2009
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
FDA Recall
Terminated
·KCI USA, INC.·Product code OMP·June 8, 2020
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
FDA Recall
Terminated
·KCI USA, INC.·Product code OMP·January 30, 2014
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
FDA Recall
Terminated
·KCI USA, Inc.·Product code GFD·May 19, 2014
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013.
FDA Recall
Terminated
·KCI USA, Inc.·Product code OMP·November 4, 2009
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
FDA Recall
Open, Classified
·KCI USA, INC.·Product code OMP·January 17, 2025
Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.
FDA Recall
Terminated
·Stryker Endoscopy·Product code FCS·May 9, 2008
Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code KCB·April 8, 2024
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
FDA Recall
Open, Classified
·Sklar Instruments·Product code KCG·December 3, 2024
Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.
FDA Recall
Terminated
·Stryker Endoscopy·Product code FCS·May 9, 2008
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
FDA Recall
Terminated
·Cook Inc.·Product code FCS·March 7, 2017
FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
FDA Recall
Terminated
·Microtek Medical Inc·Product code FYA·March 10, 2015
FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
FDA Recall
Terminated
·Microtek Medical Inc·Product code FYA·March 10, 2015
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
FDA Recall
Terminated
·Microtek Medical Inc·Product code FYA·March 10, 2015
TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.
FDA Recall
Terminated
·Microtek Medical Inc·Product code FYD·March 10, 2015
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
FDA Recall
Terminated
·GE Medical Systems, SCS·Product code OWB·March 29, 2018
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code LLZ·September 5, 2025
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Recall
Open, Classified
·GE Medical Systems, SCS·Product code OWB·March 18, 2024
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
FDA Recall
Open, Classified
·GE Medical Systems SCS·Product code LLZ·May 8, 2026