BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)

    FDA Recall
    Terminated ·Philips Consumer Lifestyle·Product code FLL·February 2, 2018

    regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OGR·October 20, 2022

    Ear Candles made from either Paraffin or Beeswax, in plain, herbal scented, or lavender scented varieties, manufactured by Wally's Natural Products, Auburn, CA.

    FDA Recall
    Terminated ·Wally's Natural Products·February 17, 2010

    Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.

    FDA Recall
    Terminated ·Maytex Corp·Product code FXX·May 15, 2013

    REGARD Ear Tray

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OGR·August 10, 2021

    Otocell Ear Wick 15mm Catalog #: BMPEW0915

    FDA Recall
    Terminated ·Ultracell Medical Technologies·Product code KCN·January 8, 2003

    GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

    FDA Recall
    Terminated ·Medegen Medical Products, LLC·Product code KCP·April 30, 2003

    HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. The Helix consists of a fantail, electrode lead, and Helix electrode array. The electrode, comprised of platinum-iridium wires, is housed in a silicone carrier and extends from the titanium case. The Helix electrode array is 24.5 mm in length and is designed to be inserted approximately 18-21 mm into a normal patent cochlea. It consists of 16 planar contacts arranged along the medial surface of the electrode array for stimulation of discrete segments of the cochlea. The Helix electrode insertion tool is designed to assist the surgeon with the insertion of the Helix electrode. Only the Helix insertion should be used for insertion of the Helix electrode; the use of other instruments may result in damage to the electrode. The insertion tool is a single-use instrument.

    FDA Recall
    Terminated ·Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342·Product code MCM·September 14, 2007

    Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915

    FDA Recall
    Terminated ·Boston Medical Products, Inc.·January 22, 2003

    Ultracell Ear Wick Fenestrated 9mm DIA x 15mm Catalog #: 30305-C

    FDA Recall
    Terminated ·Ultracell Medical Technologies·Product code KCN·January 8, 2003

    Ultracell Ear Wick 9mm DIA x 24 mm Catalog #: 30310-C

    FDA Recall
    Terminated ·Ultracell Medical Technologies·Product code KCN·January 8, 2003

    Ultracell Ear Wick 9mm DIA x 15 mm Catalog #: 30300-C

    FDA Recall
    Terminated ·Ultracell Medical Technologies·Product code KCN·January 8, 2003

    Ultracell Ear Wick 7mm DIA x 12 mm ( Pediatric) Catalog #: 30301-C

    FDA Recall
    Terminated ·Ultracell Medical Technologies·Product code KCN·January 8, 2003

    TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DJR--·December 5, 2003

    Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *Tubing Made in Mexico. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510(k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.

    FDA Recall
    Terminated ·Busse Hospital Disposables·Product code EBR·April 13, 2004

    lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.

    FDA Recall
    Terminated ·Alere San Diego Inc. DBA Immunalysis Corporation·Product code DJR·November 28, 2017

    ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DJR--·December 5, 2003

    Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.

    FDA Recall
    Terminated ·Busse Hospital Disposables·Product code EBR·April 13, 2004

    VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    FDA Recall
    Terminated ·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008

    Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

    FDA Recall
    Terminated ·Alere San Diego dba Biosite Innovacon Hemosense Inc·Product code DJR·March 12, 2010