BEUDAMED
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    Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 15, 2016

    Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·January 14, 2015

    Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code LNN·September 2, 2003

    Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KHP·April 13, 2016

    Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.

    FDA Recall
    Terminated ·Steris Corporation·Product code FST·November 26, 2014

    EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code JJE·December 22, 2015

    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

    FDA Recall
    Terminated ·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015

    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    FDA Enforcement
    Class II ·Terminated·MEDLINE IND·January 18, 2017

    Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code LPN·June 30, 2009

    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    FDA Recall
    Terminated ·MEDLINE IND·Product code KMJ·December 12, 2016

    Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code LYL·December 22, 2010

    Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code MRC·October 30, 2009

    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

    FDA Recall
    Terminated ·TERRIFIC CARE LLC 61 Willet St Bldg A-1, Fl 2 Passaic NJ 07055-1971·Product code GJS·December 20, 2018

    Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 90 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-104.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FFL·December 20, 2005

    IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CFL·August 9, 2010

    Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FFL·December 20, 2005

    Bard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FFL·December 22, 2003

    Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code FFL·December 22, 2003

    V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Cardinal Health 1430 Waukegan Rd Attn V. Mueller Qa McGaw Park IL 60085·Product code FFL·October 27, 2004

    Nichols Advantage Sample hGH Diluent Set (Catalog No. 62-7756)

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CFL·May 2, 2005