BEUDAMED
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    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.

    FDA Recall
    Terminated ·NOVADAQ TECHNOLOGIES INC.·Product code IZI·August 18, 2016

    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Recall
    Terminated ·NOVADAQ TECHNOLOGIES INC.·Product code MMP·June 27, 2017

    Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 4, 2017

    Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 4, 2017

    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

    FDA Recall
    Terminated ·Cook Inc.·Product code FHQ·May 1, 2017

    BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include fluids with specific gravity less than 1. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative or wound site. When connected to a suction source, the device can be used to aspirate fluids from the operative or wound site.

    FDA Recall
    Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FHQ·July 30, 2009

    BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.

    FDA Recall
    Terminated ·Boss Instruments, Ltd.·Product code FHQ·June 26, 2020

    DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23

    FDA Recall
    Terminated ·Dufner Instrumente GmbH Fohrenstr. 9 Tuttlingen Germany·Product code FHQ·June 3, 2020

    ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code KHQ·March 5, 2018

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code GHQ·February 7, 2018

    Norian CRS Rotary Mixer Cement 10cc sterile

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code GXP·September 14, 2009

    Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code NKB·March 11, 2011

    02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.621S, 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010

    02.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010