BEUDAMED
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    Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code JIF·November 29, 2016

    Kit BD Max ExK TNA 2; Catalog # 442825

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    Kit BD Max ExK DNA 1 USA; Catalog # 442817

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    Kit BD Max ExK DNA 2 USA; Catalog # 442819

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code N/A·July 17, 2019

    Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code N/A·July 17, 2019

    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LDP·July 20, 2017

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code LDP·January 22, 2016

    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HXK·September 25, 2019

    Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090

    FDA Recall
    Terminated ·Manan Medical Products, Inc.·Product code KXK·May 3, 2005

    BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons.

    FDA Recall
    Terminated ·Bard Brachytherapy, Inc.·Product code KXK·April 10, 2018

    HealthPax Cranial Electrotherapy Stimulator

    FDA Recall
    Terminated ·Health Directions, Inc·Product code JXK·July 19, 2007

    CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024

    FDA Recall
    Terminated ·Neuro-Fitness LLC·Product code JXK·October 29, 2007

    Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code HXK·November 8, 2011

    PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.

    FDA Recall
    Terminated ·Theragenics Corporation·Product code KXK·May 16, 2005

    M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.

    FDA Recall
    Terminated ·Source Production & Equipment Inc·Product code KXK·March 3, 2008

    VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code KXK·January 25, 2012

    I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code KXK·December 9, 2016

    Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000. RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy.

    FDA Recall
    Terminated ·Medi-Physics Inc. dba GE Healthcare·Product code KXK·September 20, 2011