BEUDAMED
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    YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.

    FDA Recall
    Terminated ·Nidek Inc·Product code LXS·March 6, 2015

    Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·August 26, 2015

    Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.

    FDA Recall
    Terminated ·Surgical Specialties Corp·Product code GAR·September 24, 2005

    Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Enforcement
    Class II ·Terminated·Burlington Medical, LLC·August 7, 2019

    Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Recall
    Terminated ·Burlington Medical, LLC·Product code EAJ·June 7, 2019

    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.

    FDA Recall
    Terminated ·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011

    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code JBD·June 29, 2004

    RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code GKA·September 14, 2004

    Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code JIA·September 8, 2004

    Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/-10 mmHg from +301 to +500 mmHg. The Pressure Display Box has an upper and lower alarm setting. The alarm will be activated when the pressure is equal to or beyond the set value. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55431-5604. Product Usage: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DXS·September 9, 2011

    TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor sternal bone quality.

    FDA Recall
    Terminated ·KARDIUM INC. 100·Product code HXS·March 31, 2010

    TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile.

    FDA Recall
    Terminated ·Kardium 12851 Rowan Pl Richmond Canada British Columbia·Product code HXS·August 28, 2012

    DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DXS·June 22, 2017

    Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DXS·September 9, 2011

    Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of tubing features a male luer port. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DXS·September 9, 2011

    Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.

    FDA Recall
    Terminated ·Aspen Surgical Puerto Rico Corp. Rd 183 Km 20.3 Las·Product code GES·June 27, 2016

    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

    FDA Recall
    Terminated ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·October 3, 2016

    PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm

    FDA Recall
    Terminated ·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code NKB·April 9, 2021

    Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

    FDA Recall
    Terminated ·SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland·Product code MAX·February 5, 2019