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    Ref: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code KQM·March 18, 2013

    QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

    FDA Recall
    Terminated ·Z-Medica, LLC·Product code FRO·November 17, 2017

    Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJK·April 8, 2024

    SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

    FDA Recall
    Terminated ·Sunstar Americas, Inc.·Product code NTO·May 21, 2021

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DYB·December 10, 2020

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DYB·December 10, 2020

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DYB·December 10, 2020

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DYB·December 10, 2020

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DYB·December 10, 2020

    CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths.

    FDA Recall
    Terminated ·Numed Inc·Product code MAF·June 26, 2003

    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

    FDA Recall
    Terminated ·Numed Inc·Product code NVM·April 21, 2025

    IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.

    FDA Recall
    Terminated ·Numed Inc·Product code LIT·September 23, 2009

    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.

    FDA Recall
    Terminated ·Numed Inc·Product code DQO·October 17, 2018

    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.

    FDA Recall
    Terminated ·Numed Inc·Product code DQO·October 17, 2018

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DYB·December 10, 2020

    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code ELW·February 4, 2013

    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code ELW·February 4, 2013

    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

    FDA Recall
    Terminated ·Clinician's Choice Dental Products Inc.·Product code ELW·March 18, 2022

    SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only.

    FDA Recall
    Terminated ·TZ Medical Inc.·Product code FRO·October 14, 2015

    PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code MNI·November 20, 2013