BEUDAMED
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    RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11, 133FV-12, 133FV-13, 133FV-14, 133FV-15, 133FV-16; STYLE 133MV: 133MV-11, 133MV-12, 133MV-13, 133MV-14, 133MV-15, 133MV-16; STYLE 133LV: 133LV-11, 133LV-12, 133LV-13, 133LV-14, 133LV-15, 133LV-16; STYLE 133FX: 133FX-11 133FX-12 133FX-13 133FX-14 133FX-15 133FX-16 STYLE 133MX: 133MX-11, 133MX-12, 133MX-13, 133MX-14, 133MX-15, 133MX-16; STYLE 133SX: 133SX-11, 133SX-12, 133SX-13, 133SX-14, 133SX-15, 133SX-16; STYLE 133SV: 133SV-11, 133SV-12, 133SV-13, 133SV-14, 133SV-15, 133SV-16; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

    FDA Recall
    Open, Classified ·Allergan PLC·Product code LCJ·July 24, 2019

    Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-FV-16; STYLE 133P-MV: 133P-MV-11, 133P-MV-12, 133P-MV-13, 133P-MV-14, 133P-MV-15, 133P-MV-16; STYLE 133P-LV: 133P-LV-11, 133P-LV-12, 133P-LV-13, 133P-LV-14, 133P-LV-15, 133P-LV-16; STYLE 133P-FX: 133P-FX-11, 133P-FX-12, 133P-FX-13, 133P-FX-14, 133P-FX-15, 133P-FX-16; STYLE 133P-MX:133P-MX-11,133P-MX-12, 133P-MX-13, 133P-MX-14, 133P-MX-15, 133P-MX-16; STYLE 133P-SX: 133P-SX-11, 133P-SX-12, 133P-SX-13, 133P-SX-14, 133P-SX-15, 133P-SX-16; STYLE 133P-SV: 133P-SV-11,133P-SV-12, 133P-SV-13, 133P-SV-14, 133P-SV-15, 133P-SV-16; STYLE 133P-FV-T:133P-FV-11-T, 133P-FV-12-T, 133P-FV-13-T, 133P-FV-14-T, 133P-FV-15-T, 133P-FV-16-T; STYLE 133P-MV-T: 133P-MV-11-T, 133P-MV-12-T, 133P-MV-13-T, 133P-MV-14-T, 133P-MV-15-T, 133P-MV-16-T; STYLE 133P-LV-T: 133P-LV-11-T, 133P-LV-12-T, 133P-LV-13-T, 133P-LV-14-T, 133P-LV-15-T, 133P-LV-16-T; STYLE 133P-FX-T: 133P-FX-11-T, 133P-FX-12-T, 133P-FX-13-T, 133P-FX-14-T, 133P-FX-15-T, 133P-FX-16-T; STYLE 133P-MX-T: 133P-MX-11-T, 133P-MX-12-T, 133P-MX-13-T, 133P-MX-14-T, 133P-MX-15-T, 133P-MX-16-T; STYLE 133P-SX-T: 133P-SX-11-T, 133P-SX-12-T, 133P-SX-13-T, 133P-SX-14-T, 133P-SX-15-T, 133P-SX-16-T; STYLE 133P-SV-T: 133P-SV-11-T, 133P-SV-12-T, 133P-SV-13-T, 133P-SV-14-T, 133P-SV-15-T, 133P-SV-16-T These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed

    FDA Recall
    Open, Classified ·Allergan PLC·Product code LCJ·July 24, 2019

    Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T, 133MV-16-T; STYLE 133LV-T: 133LV-11-T, 133LV-12-T, 133LV-13-T, 133LV-14-T, 133LV-15-T, 133LV-16-T; STYLE 133SV-T: 133SV-11-T, 133SV-12-T, 133SV-13-T, 133SV-14-T, 133SV-15-T, 133SV-16-T STYLE 133FX-T: 133FX-11-T, 133FX-12-T, 133FX-13-T, 133FX-14-T, 133FX-15-T, 133FX-16-T; STYLE 133MX-T: 133MX-11-T, 133MX-12-T, 133MX-13-T, 133MX-14-T, 133MX-15-T, 133MX-16-T; STYLE 133SX-T: 133SX-11-T, 133SX-12-T, 133SX-13-T, 133SX-14-T, 133SX-15-T, 133SX-16-T; Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

    FDA Recall
    Open, Classified ·Allergan PLC·Product code LCJ·July 24, 2019

    Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800; Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690; Syle 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FWM·July 24, 2019

    McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

    FDA Recall
    Open, Classified ·Medtronic, PLC·Product code CCW·January 28, 2020

    XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

    FDA Recall
    Open, Classified ·Allergan PLC·Product code KYF·October 30, 2019

    Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203, 115-222, 115-253, 115-272, 115-290, 115-322, 115-354, 115-378, 115-401, 115-435, 115-469, 115-507, 115-547, 115-586, 115-627, 115-666, 115-716; Style 120: 120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

    FDA Recall
    Open, Classified ·Allergan PLC·Product code LCJ·July 24, 2019

    Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220,TRLP-235,TRLP-250, TRLP-265,TRLP-280,TRLP-300,TRLP-320,TRLP-340,TRLP-360,TRLP-400,TRLP-440,TRLP-490,TRLP-540,TRLP-590,TRLP-640; Style TRM: TRM-140,TRM-175,TRM-195,TRM-210,TRM-240,TRM-255,TRM-275,TRM-295,TRM-310,TRM-330,TRM-345,TRM-360,TRM-375TRM-405,TRM-445,TRM-485,TRM-520,TRM-560,TRM-600,TRM-640,TRM-685,TRM-755 Style TRF: TRF-180TRF-200,TRF-220,TRF-240,TRF-265,TRF-295,TRF-325,TRF-335,TRF-345,TRF-365,TRF-385,TRF-415,TRF-450,TRF-485,TRF-520,TRF-560,TRF-605,TRF-650,TRF-695,TRF-745,TRF-770; Style TRX: TRX-205,TRX-225,TRX-255,TRX-285,TRX-310,TRX-340,TRX-375,TRX-400,TRX-420,TRX-445,TRX-470,TRX-495,TRX-525,TRX-545,TRX-560,TRX-580,TRX-615,TRX-650,TRX-700,TRX-750,TRX-800; Style TSL: TSL-110, TSL-125, TSL-140, TSL-170, TSL-200, TSL-230, TSL-260, TSL-290, TSL-320, TSL-350, TSL-380, TSL-410, TSL-460, TSL-510, TSL-560, TSL-610; Style TSLP: TSLP-125, TSLP-145, TSLP-165, TSLP-190, TSLP-205, TSLP-220, TSLP-235, TSLP-250, TSLP-265, TSLP-280, TSLP-300, TSLP-320, TSLP-340, TSLP-360, TSLP-400, TSLP-440, TSLP-490, TSLP-540, TSLP-590, TSLP-640; Style TSM: TSM-140, TSM-175, TSM-195, TSM-210, TSM-240, TSM-255, TSM-275, TSM-295, TSM-310, TSM-330, TSM-345, TSM-360, TSM-375, TSM-405, TSM-445, TSM-485, TSM-520, TSM-560, TSM-600, TSM-640, TSM-685, TSM-755; Style TSF: TSF-180 TSF-200 TSF-220 TSF-240 TSF-265 TSF-295 TSF-325 TSF-335 TSF-345 TSF-365 TSF-385 TSF-415 TSF-450 TSF-485 TSF-520 TSF-560 TSF-605 TSF-650 TSF-695 TSF-745 TSF-770 Style TSX: TSX-205, TSX-225, TSX-255, TSX-285, TSX-310, TSX-340, TSX-375, TSX-400, TSX-420, TSX-445, TSX-470, TSX-495, TSX-525, TSX-545, TSX-560, TSX-580, TSX-615, TSX-650, TSX-700, TSX-750, TSX-800; Style TCL: TCL-110, TCL-125, TCL-140, TCL-170, TCL-200, TCL-230, TCL-260, TCL-290, TCL-320, TCL-350, TCL-380, TCL-410, TCL-460, TCL-510, TCL-560, TCL-610; Style TCLP: TCLP-125, TCLP-145, TCLP-165, TCLP-190, TCLP-205, TCLP-220, TCLP-235, TCLP-250, TCLP-265, TCLP-280, TCLP-300, TCLP-320, TCLP-340, TCLP-360, TCLP-400, TCLP-440, TCLP-490, TCLP-540, TCLP-590, TCLP-640; Style TCM: TCM-140, TCM-175, TCM-195, TCM-210, TCM-240, TCM-255, TCM-275 TCM-295 TCM-310, TCM-330, TCM-345, TCM-360, TCM-375, TCM-405, TCM-445, TCM-485, TCM-520, TCM-560, TCM-600, TCM-640, TCM-685, TCM-755; Style TCF: TCF-180 TCF-200 TCF-220 TCF-240 TCF-265 TCF-295 TCF-325 TCF-335 TCF-345 TCF-365 TCF-385 TCF-415 TCF-450 TCF-485 TCF-520 TCF-560 TCF-605 TCF-650 TCF-695 TCF-745 TCF-770 Style TCX: TCX-205, TCX-225, TCX-255, TCX-285, TCX-310, TCX-340, TCX-375, TCX-400 TCX-420, TCX-445, TCX-470, TCX-495, TCX-525, TCX-545, TCX-560, TCX-580, TCX-615, TCX-650, TCX-700, TCX-750, TCX-800; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-410125, LF-410150,LF-410175,LF-410205,LF-410240,LF-410270,LF-410310,LF-410390,LF-410440,LF-410490,LF-410540,LF-410595,LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; style LX: LX-410145,LX-410175,LX-410195,LX-410225,LX-410255,LX-410290,LX-410330,LX-410365,LX-410405,LX-410455,LX-410515,LX-410570,LX-410625; Style ML: ML-410125,ML-410170,ML-410195,ML-410220,ML-410285; Style MM: MM-410160,MM-410185,MM-410215,MM-410245,MM-410280,MM-410320,MM-410360,MM-410400,MM-410450; Style MF: MF-410140MF-410165,MF-410195,MF-410225,MF-410255,MF-410295,MF-410335,MF-410375,MF-410420,MF-410470,MF-410525,MF-410580,MF-410640; Style MX: MX-410165,MX-410195,MX-410225,MX-410255,MX-410290,MX-410325,MX-410370,MX-410410,MX-410445,MX-410520,MX-410550,MX-410620,MX-410685; Style FL: FL-410140,FL-410190,FL-410220,FL-410250,FL-410320; Style FM:FM-410155,FM-410180,FM-410205,FM-410235,FM-410270,FM-410310,FM-410350,FM-410395,FM-410440,FM-410500,FM-410550,FM-410605,FM-410670; Style FF: FF-410160,FF-410185,FF-410220,FF-410255,FX-410290,FF-410335,FF-410375,FF-410425,FF-410475,FF-410535,FF-410595,FF-410655,FF-410740; Style FX: FX-410185FX-410215,FX-410245,FX-410280,FX-410315,FX-410360,FX-410410,FX-410450,FX-410495,FX-410560,FX-410615,FX-410690,FX-410775 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·September 14, 2023

    Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System

    FDA Recall
    Open, Classified ·GE Healthcare·Product code LLZ·September 14, 2023

    The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the anomaly, and thrombosing the target site. The Prestige Coil System is comprised of the implant coil and a pusher assembly. There are a total of 81 Prestige coil models. Vascular Embolization Device Prestige Coil Model Numbers and Product description: PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES1137COM18 Prestige Coil 11mm x 37cm Complex-18 PRES0202CXPPL Prestige Coil 2mm x 2cm Prestige Plus Complex Xtra Pac PRES0203CXPPL Prestige Coil 2mm x 3cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0620HPKPL Prestige Coil 6mm x 20cm Prestige Plus Helical Pack PRES0720CPKPL Prestige Coil 7mm x 20cm Prestige Plus Complex Pack PRES0930CPKPL Prestige Coil 9mm x 30cm Prestige Plus Complex Pack PRES0101HXPPL Prestige Coil 1mm x 1cm Prestige Plus Helical Xtra Pac PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0930HPKPL Prestige Coil 9mm x 30cm Prestige Plus Helical Pack PRES1040HPKPL Prestige Coil 10mm x 40cm Prestige Plus Helical Pack PRES1240COM18 Prestige Coil 12mm x 40cm Complex-18 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0206CXPPL Prestige Coil 2mm x 6cm Prestige Plus Complex Xtra Pac PRES0310CXPPL Prestige Coil 3mm x 10cm Prestige Plus Complex Xtra Pac PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0830CPKPL Prestige Coil 8mm x 30cm Prestige Plus Complex Pack PRES0210CXP10 Prestige Coil 2mm x 10cm Complex-10 Xtra Pack PRES0258CXP10 Prestige Coil 2.5mm x 8cm Complex-10 Xtra Pack PRES0417CPK10 Prestige Coil 4mm x 17cm Complex-10 Xtra Pack PRES0520CPK10 Prestige Coil 5mm x 20cm Complex-10 Xtra Pack PRES0615CPK10 Prestige Coil 6mm x 15cm Complex-10 Xtra Pack PRES0103CXPPL Prestige Coil 1mm x 3cm Prestige Plus Complex Xtra Pac PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CPKPL Prestige Coil 4mm x 13cm Prestige Plus Complex Pack PRES2525HXPPL Prestige Coil 2.5mm x 2.5cm Prestige Plus Helical Xtra Pac PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0517CPKPL Prestige Coil 5mm x 17cm Prestige Plus Complex Pack PRES0620CPKPL Prestige Coil 6mm x 20cm Prestige Plus Complex Pack PRES0152CXPPL Prestige Coil 1.5mm x 2cm Prestige Plus Complex Xtra Pac PRES0413CRG10 Prestige Coil 4mm x 13cm Complex 10 Regular PRES0153CXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Complex Xtra Pac PRES0255CXPPL Prestige Coil 2.5mm x 5cm Prestige Plus Complex Xtra Pac PRES0358CXPPL Prestige Coil 3.5mm x 8cm Prestige Plus Complex Xtra Pac PRES0410CPKPL Prestige Coil 4mm x 10cm Prestige Plus Complex Pack PRES1040CPKPL Prestige Coil 10mm x 40cm Prestige Plus Complex Pack PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0206HXP10 Prestige Coil 2mm x 6cm Helical-10 Xtra Pack PRES1447COM18 Prestige Coil 14mm x 47cm Complex-18 PRES0204HXP10 Prestige Coil 2mm x 4cm Helical-10 Xtra Pack PRES0306HPK10 Prestige Coil 3mm x 6cm Helical-10 Pack PRES0310HPK10 Prestige Coil 3mm x 10cm Helical-10 Pack PRES0410HPK10 Prestige Coil 4mm x 10cm Helical-10 Pack PRES0930H

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