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    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·February 4, 2013

    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·February 4, 2013

    LightMix Zika rRT-PCR Test The LightMix Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities. Within the United States and its territories positive results must be reported to appropriate state/local public health authorities. Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The LightMix Zika rRT-PCR Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of realtime PCR and in vitro diagnostic procedures. The Test is only for use under the Food and Drug Administration s Emergency Use Authorization.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code POA·November 16, 2016

    AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code DYJ·June 6, 2013

    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.

    FDA Recall
    Terminated ·Allesee Orthodontic Appliances·Product code DYJ·February 24, 2014

    Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",

    FDA Recall
    Terminated ·Ameditech Inc·Product code LDJ·August 18, 2020

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    FDA Recall
    Open, Classified ·NOA Medical Industries Inc·Product code IKX·November 5, 2024

    Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    ConMed System 2450 Electrosurgical Generator, REF 60-2450-230, 230V-240V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.

    FDA Recall
    Terminated ·ConMed Electrosurgery·Product code GEI·December 27, 2010

    ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site

    FDA Recall
    Terminated ·ConMed Electrosurgery·Product code GEI·December 27, 2010

    ConMed System 2450 Electrosurgical Generator, REF 60-2450-220, 220 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.

    FDA Recall
    Terminated ·ConMed Electrosurgery·Product code GEI·December 27, 2010

    ConMed System 2450 Electrosurgical Generator, REF 60-2450-120, 120 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.

    FDA Recall
    Terminated ·ConMed Electrosurgery·Product code GEI·December 27, 2010

    ConMed System 2450 Electrosurgical Generator, REF 60-2450-120-69, 120V, (Refurbished), ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.

    FDA Recall
    Terminated ·ConMed Electrosurgery·Product code GEI·December 27, 2010

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Recall
    Terminated ·Paa Laboratories Inc 145 Bethridge Road Etobicoke Canada Ontario·Product code KIS·April 12, 2013

    Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.

    FDA Recall
    Terminated ·Cook Inc.·Product code KOA·May 1, 2017

    Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code DOA·October 15, 2007

    ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.

    FDA Recall
    Terminated ·Uromedica Inc.·Product code KOA·April 10, 2019

    PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

    FDA Recall
    Completed ·Aesculap Implant Systems LLC·Product code KOA·April 1, 2020

    PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

    FDA Recall
    Completed ·Aesculap Implant Systems LLC·Product code KOA·April 1, 2020

    Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.

    FDA Recall
    Terminated ·Cook Inc.·Product code KOA·May 1, 2017