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    176 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

    FDA Recall
    Open, Classified ·G & H Wire Company·Product code ECI·December 21, 2023

    OPMI LUMERA 300, REF 6137

    FDA Recall
    Open, Classified ·Carl Zeiss Suzhou Co., Ltd. Modern Industrial Square·Product code FSO·August 18, 2023

    LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

    FDA Recall
    Open, Classified ·Zest Anchors LLC·Product code DZE·November 22, 2019

    Phoroptor VRx Digital Refraction System Model Numbers: 16242

    FDA Recall
    Open, Classified ·Reichert, Inc.·Product code HKN·February 28, 2025

    Phoroptor VRx Digital Refraction System Model Numbers: 16241

    FDA Recall
    Open, Classified ·Reichert, Inc.·Product code HKN·February 28, 2025

    Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.

    FDA Recall
    Open, Classified ·Berkeley Advanced Biomaterials, LLC·Product code MQV·September 2, 2025

    6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FMG·August 1, 2022

    8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022

    MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022

    6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022

    MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPD·August 1, 2022

    6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FPA·August 1, 2022

    Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S-606 SOFSILK* 0 BLK 2X150CM PCT X36 S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 S-610 SOFSILK* 5 BLK 2X150CM PCT X12 SOFSILK 2-0 30 BK CV-24 GS453-2 SOFSLK 4-0 24 BK CV-15 DA VS581-2 ***Added 4/1/24*** CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA S-282 SOFSILK* 5 BLK 3X60CM PCT X36 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA 3226-31 TICRON* 4-0 BLU 60CM CV330 DA 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863087-31 TICRON* 4-0 BLU 75CM CV33DA 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863147-83 TICRON 2 BLU 5X75CM KV37X12 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-31 TICRON* 4-0 BLU 75CM CV331 88863226-31 TICRON* 4-0 BLU 60CM CV330DA 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863229-31 TICRON* 4-0 BLU 75CM CV307DA 88863271-31 TICRON* 4-0 BLU 90CM CV331DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12

    FDA Recall
    Open, Classified ·Product code GAP·December 21, 2023

    PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870

    FDA Recall
    Open, Classified ·Ethicon, Inc. Us·Product code GAP·June 10, 2020

    A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

    FDA Recall
    Open, Classified ·Genicon, Inc.·Product code FZP·September 17, 2020

    Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code FZP·April 28, 2023

    Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36 GS835 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S1172 S-1173 SOFSILK* 5-0 BLK 45CM C1 X36 S1173 S-1174 SOFSILK* 4-0 BLK 45CM C1 X36 S1174 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S1750K S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S176 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S1768K S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S182 S-183 SOFSILK* 4-0 BLK 12X45CM PCT X36 S183 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S184 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S185 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S187 S-206 SOFSILK* 2 BLK 100CM STDLTH X36 S206 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S243 S-244 SOFSILK* 3-0 BLK 12X60CM PCT X36 S244 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S245 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S246 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S2782K S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S303 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S304 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S305 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S316 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S317 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S318 S-346 SOFSILK* 0 BLK 12X60CM PCT X24 S346 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S605 S-607 SOFSILK* 1 BLK 2X150CM PCT X36 S607 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 S608 SS-523 SOFSILK* 2-0 BLK 75CM SC1 X36 SS523 SS-525 SOFSILK* 1 BLK 75CM SC1 X36 SS525 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS5641 SS-5641G SOFSILK* 4-0 BLK 45CM P13 X12 SS5641G SS-5678 SOFSILK* 5-0 BLK 45CM P11 X36 SS5678 SS-5684 SOFSILK* 3-0 BLK 45CM P14 X36 SS5684 SS-623 SOFSILK* 2-0 BLK 75CM SC2 X36 SS623 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS645 SS-653 SOFSILK* 4-0 BLK 75CM C13 X36 SS653 SS-673 SOFSILK* 5-0 BLK 75CM C12 X36 SS673 SS-683G SOFSILK* 4-0 BLK 45CM C13 X12 SS683G SS-685G SOFSILK* 2-0 BLK 45CM C15 X12 SS685G SS-686 SOFSILK* 4-0 BLK 45CM C12 X12 SS686 SS-689 SOFSILK* 1 BLK 75CM C16 X36 SS689 SS-745 SOFSILK* 3-0 BLK 75CM C12 X36 SS745 SS-786 SOFSILK* 0 BLK 75CM C14 X36 SS786 SS-787 SOFSILK* 1 BLK 75CM C14 X36 SS787 VS-533 SOFSILK* 2-0 BLK 90CM V20 DAX36 VS533 VS-845 SOFSILK* 1 BLK 75CM V26 X36 VS845 VS-870 SOFSILK* 5-0 BLK 75CM CV23 X36 VS870 VS-871 SOFSILK* 4-0 BLK 75CM CV23 X36 VS871 SOFSILK 4-0 30 BK CV-23 VS871-2 VS8712 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872 SOFSILK 3-0 30 BK CV-23 VS872-2 VS8722 VS-882 SOFSILK* 3-0 BLK 75CM CV15 X36 VS882 SOFSILK 5-0 30 BK CV-11 VS890-2 VS8902 XX-5278 SOFSILK* 3-0 BLK 150CM PCT X36 XX5278 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 XX5280 XX-5281 SOFSILK* 1 BLK 150CM PCT X36 XX5281 XX-5284 SOFSILK* 4 BLK 150CM PCT X36 XX5284

    FDA Recall
    Open, Classified ·Product code GAP·December 2, 2022

    WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

    FDA Recall
    Open, Classified ·Teleflex Medical·Product code FZP·October 4, 2019

    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

    FDA Recall
    Open, Classified ·Teleflex Medical·Product code FZP·October 4, 2019

    Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.

    FDA Recall
    Open, Classified ·Product code GAP·January 25, 2024