BEUDAMED
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    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

    Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNN·August 12, 2005

    Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LNN·August 12, 2005

    740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008

    HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·March 12, 2014

    Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 20, 2017

    Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Manufactured by Soft Lens Technology, Lot BB43 Expiration Date 08/06, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip, Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire..

    FDA Recall
    Terminated ·The Contact Lens Store, Inc.·Product code LPL·June 7, 2004

    Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer

    FDA Enforcement
    Class III ·Terminated·Lin-Zhi International Inc·April 2, 2014

    Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.

    FDA Enforcement
    Class III ·Terminated·Lin-Zhi International Inc·December 4, 2013

    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Enforcement
    Class II ·Terminated·Lin-Zhi International Inc·March 19, 2014

    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Enforcement
    Class II ·Terminated·Lin-Zhi International Inc·March 19, 2014

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    FDA Enforcement
    Class III ·Terminated·Lin-Zhi International Inc·May 8, 2019

    Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code HNN·December 22, 2006

    PremierEdge MICROSURGICAL KNIFE, 45 DEGREES STAB KNIFE, REF/Item Code: PE 3045, OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF: PE 3830; OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife, Item Code/ REF: PE 3128 , OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF: PE4828-TL; OASIS Glendora, CA 91741

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

    BD Beaver Mini-Blade, Blade Mini Orthopedic 1.31 in, Catalog Number: 376100

    FDA Recall
    Terminated ·Becton Dickinson and Company·Product code HNN·December 26, 2006

    Stylus Brand Angled Knife 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm 52-3231, Slit Knife, double bevel, angled, full handle, 3.2mm

    FDA Recall
    Terminated ·Surgical Specialties Puerto Rico, Inc. Road·Product code HNN·March 3, 2004