BEUDAMED
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    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HRX·June 24, 2020

    INZONE DETACHMENT SYSTEM, REF: M00345100950

    FDA Recall
    Open, Classified ·Stryker Neurovascular·Product code HCG·April 6, 2026

    Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·September 7, 2022

    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

    Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded. There are a total of 208 Optima Coil models. Optima Coil Model Numbers and Product description: OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Opti

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·January 3, 2024

    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

    Beacon EUS Access System Preloaded Access 135degree 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

    The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·January 4, 2022

    BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code FCG·August 2, 2024

    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 Models: NA-U401SX-4022, NA-U401SX-4022-A

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

    Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 00818053026461 OPTI1137COM18 00818053026478 OPTI1550COM18 00818053026515 OPTI0101CSS10 00818053025709 OPTI0101HSS10 00840303700951 OPTI0102CSS10 00818053025716 OPTI0102HSS10 00840303700968 OPTI0103HSS10 00818053026591 OPTI0103CSS10 00818053025723 OPTI0104HSS10 00818053026607 OPTI0254CSS10 00840303700548 OPTI0255CSF10 00840303700203 OPTI0256CSS10 00818053025853 OPTI0256HSS10 00818053026737 OPTI0202HSS10 00840303701040 OPTI0203HSS10 00840303701057 OPTI0203CSS10 00818053025785 OPTI0204CSS10 00840303700494 OPTI0204HSS10 00840303701064 OPTI0206CSF10 00818053026027 OPTI0206CSS10 00818053025808 OPTI0208CSF10 00818053026034 OPTI0208HSS10 00840303701088 OPTI0208CSS10 00840303700517 OPTI0358CSS10 00818053025921 OPTI0310HSS10 00840303701156 OPTI0310CSS10 00818053025907 OPTI0310HSF10 00840303700814 OPTI0310CSF10 00840303700234 OPTI0304HSS10 00840303701125 OPTI0304HSF10 00840303700784 OPTI0304CSS10 00818053025877 OPTI0306HSS10 00840303701132 OPTI0308HSS10 00840303701149 OPTI0308CSF10 00818053026065 OPTI0308CSS10 00840303700593 OPTI0410CSS10 00840303700654 OPTI0410HSF10 00840303700852 OPTI0413CSF10 00818053026119 OPTI0406HSS10 00840303701163 OPTI0408HSS10 00818053026799 OPTI0413CST10 00840303700036 OPTI0510HSS10 00840303701217 OPTI0510CSS10 00840303700685 OPTI0510HSF10 00840303700890 OPTI0513CSS10 00840303700692 OPTI0517CSF10 00818053026157 OPTI0517CST10 00840303700050 OPTI0508CSS10 00840303700678 OPTI0509CSF10 00818053026140 OPTI0610HSF10 00840303700937 OPTI0611CSF10 00818053026171 OPTI0620CSF10 00840303700357 OPTI0620HST10 00840303700715 OPTI0713CST10 00840303700081 OPTI0713CSF10 00840303700364 OPTI0724CSF10 00818053026218 OPTI0724CST10 00840303700098 OPTI0724COM18 00818053026430 OPTI0827CSF10 00818053026232 OPTI0827CST10 00840303700111 OPTI0923CST10 00818053026379 OPTI0930COM18 00818053026454 OPTI0153HSSMX 00818053025419 OPTI1040CSFMX 00818053025280 OPTI1245CSFMX 00818053025303 OPTI1445CSFMX 00818053025327 OPTI1650CSFMX 00818053025341 OPTI0103CSSMX 00840303701408 OPTI2525CSSMX 00840303701477 OPTI0255CSSMX 00818053025020 OPTI0202CSSMX 00818053024979 OPTI3535CSSMX 00818053025068 OPTI0310CSSMX 00818053025051 OPTI0307CSSMX 00818053025044 OPTI4510CSFMX 00818053025143 OPTI4545CSFMX 00818053025136 OPTI0413CSFMX 00818053025129 OPTI0404CSFMX 00818053025099 OPTI0407CSFMX 00818053025105 OPTI0510CSFMX 00818053025167 OPTI0507CSFMX 00818053025150 OPTI0715CSFMX 00818053025228 OPTI0720CSFMX 00818053025235 OPTI0930CSFMX 00818053025266 The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·May 8, 2025

    MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FCG·May 25, 2022

    Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288

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

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    FDA Recall
    Open, Classified ·Cook Medical Incorporated·Product code FCG·April 1, 2024

    AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;

    FDA Recall
    Open, Classified ·Micro Therapeutics, Inc.·Product code HCG·April 27, 2022

    Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·July 26, 2022

    EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

    FDA Recall
    Open, Classified ·Cook Medical Incorporated·Product code FCG·April 1, 2024

    CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT 8MM

    FDA Recall
    Open, Classified ·Cerenovus Inc·Product code HCG·October 2, 2025