BEUDAMED
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    Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.

    FDA Recall
    Terminated ·Pinook-Usa·Product code NGX·May 23, 2013

    Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.

    FDA Recall
    Terminated ·Pinook-Usa·Product code NGX·May 23, 2013

    Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code KIF·August 31, 2016

    Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code KIF·February 23, 2009

    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

    FDA Recall
    Terminated ·Medtronic Vascular, Inc.·Product code MIH·April 28, 2021

    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

    FDA Recall
    Terminated ·Kim's Trading Inc·Product code LPM·May 17, 2010

    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

    FDA Recall
    Terminated ·Medline Industries Inc·Product code MNL·June 15, 2018

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Recall
    Terminated ·Ki Mobility Llc·Product code INM·November 19, 2021

    COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code GIF·April 13, 2015

    VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code GIF·January 24, 2018

    Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com

    FDA Recall
    Terminated ·QUIDEL CARDIOVASCULAR INC·Product code DIF·April 9, 2019

    VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code DIF·November 30, 2021

    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIF·September 22, 2017

    Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DIF·September 23, 2013

    CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GIF·February 24, 2004

    CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GIF·April 17, 2006

    XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code DIF·June 27, 2005