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    Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.

    FDA Recall
    Terminated ·Biomet 3i, Inc.·Product code EJB·May 9, 2008

    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

    FDA Recall
    Terminated ·Clinical Innovations, LLC·Product code OQY·January 5, 2015

    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

    FDA Recall
    Terminated ·Clinical Innovations, LLC·Product code OQY·December 30, 2014

    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017

    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017

    Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

    FDA Recall
    Terminated ·MTI Precision Products LLC.·Product code EFB·May 7, 2012

    Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA

    FDA Recall
    Terminated ·DentSply Professional Division·Product code EFB·October 14, 2003

    Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

    FDA Recall
    Terminated ·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code EFB·July 8, 2016

    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·January 14, 2020

    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

    FDA Recall
    Terminated ·Ortho Organizers, Inc.·Product code EJF·April 2, 2019

    The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·April 24, 2012

    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code EJF·February 8, 2013

    Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code EJF·March 25, 2014

    Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA

    FDA Recall
    Terminated ·DentSply Professional Division·Product code EFB·October 14, 2003

    Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484

    FDA Recall
    Terminated ·Ortho Organizers, Inc.·Product code EJF·April 2, 2019

    Titanium Orthos Bracket

    FDA Recall
    Terminated ·Ormco Corporation·Product code EJF·November 18, 2004

    Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    FDA Recall
    Terminated ·Ormco Corporation·Product code EJF·February 13, 2009

    Midwest Tradition PB Non-Fiber Optic High Speed Handpiece with Push Button Chuck (4 tube connection), catalog #790044; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA

    FDA Recall
    Terminated ·DentSply Professional Division·Product code EFB·October 14, 2003

    KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A

    FDA Recall
    Terminated ·Kavo America Corporation·Product code EFB·November 22, 2006

    Midwest Tradition PB High Speed Handpiece with Push Button Chuck, catalog #790042; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA

    FDA Recall
    Terminated ·DentSply Professional Division·Product code EFB·October 14, 2003