BEUDAMED
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    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019

    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code CCW·November 27, 2019

    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

    FDA Recall
    Terminated ·Flexicare Medical Ltd. Cynon Valley Business Park, Mountain Ash Rhondda Cynon Taff United Kingdom·Product code OGH·November 27, 2019

    Calcium Sulfate Hemihydrate 1.0 gram kits.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010

    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code EMO·March 28, 2018

    Calcium Sulfate Hemihydrate 0.5 gram kits.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code LYC·May 14, 2010

    INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

    FDA Recall
    Terminated ·Ace Surgical Supply Co., Inc.·Product code DZE·February 22, 2017

    NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

    FDA Recall
    Open, Classified ·Ace Surgical Supply Co., Inc.·Product code NPM·February 2, 2022

    SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·April 26, 2011

    ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·June 7, 2011

    Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FCG·August 11, 2011

    EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code FCG·April 23, 2002

    Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN M001434571, Sterilized with ethylene oxide gas. UPN for inner pouch M001434570. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FCG·October 7, 2008

    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FCG·March 31, 2023

    Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-454, UPN M001434541, Sterilized with ethylene oxide gas. UPN for inner pouch M001434540. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FCG·October 7, 2008

    Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code FCG·February 4, 2016

    Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code FCG·June 26, 2020

    Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687. The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an outer cannula with an attached female luer lock hub, and inner stylet with an attached male luer lock hub, and a flexible slip rink depth stop.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code FCG·May 1, 2006

    Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-108, REF M0065001080 and M0065001081. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FCG·October 17, 2008