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    Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile, Single Use Only, Order #: ft r 223, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

    FDA Recall
    Terminated ·Product code FTR·September 12, 2003

    Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

    FDA Recall
    Terminated ·Product code FTR·July 1, 2016

    Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US) 10888628032835, Natrelle Inspira SSM 175cc BI (US) 10888628032842, Natrelle Inspira SSM 195cc BI (US) 10888628032859, Natrelle Inspira SSM 210cc BI (US) 10888628032866, Natrelle Inspira SSM 240cc BI (US) 10888628032873, Natrelle Inspira SSM 255cc BI (US) 10888628032880, Natrelle Inspira SSM 275cc BI (US) 10888628032897, Natrelle Inspira SSM 295cc BI (US) 10888628032903, Natrelle Inspira SSM 310cc BI (US) 10888628032910, Natrelle Inspira SSM 330cc BI (US) 10888628032927, Natrelle Inspira SSM 345cc BI (US) 10888628032934, Natrelle Inspira SSM 360cc BI (US) 10888628032941, Natrelle Inspira SSM 375cc BI (US) 10888628032958, Natrelle Inspira SSM 405cc BI (US) 10888628032965, Natrelle Inspira SSM 445cc BI (US) 10888628032972, Natrelle Inspira SSM 485cc BI (US) 10888628032989, Natrelle Inspira SSM 520cc BI (US) 10888628032996, Natrelle Inspira SSM 560cc BI (US) 10888628033009, Natrelle Inspira SSM 600cc BI (US) 10888628033016, Natrelle Inspira SSM 640cc BI (US) 10888628033023, Natrelle Inspira SSM 685cc BI (US) 10888628033030, 7608 SSF/UDI: Natrelle Inspira SSF 180cc BI (US) 10888628033054, Natrelle Inspira SSF 200cc BI (US) 10888628033061, Natrelle Inspira SSF 220cc BI (US) 10888628033078, Natrelle Inspira SSF 240cc BI (US) 10888628033085, Natrelle Inspira SSF 265cc BI (US) 10888628033092, Natrelle Inspira SSF 295cc BI (US) 10888628033108, Natrelle Inspira SSF 325cc BI (US) 10888628033115, Natrelle Inspira SSF 335cc BI (US) 10888628033122, Natrelle Inspira SSF 345cc BI (US) 10888628033139, Natrelle Inspira SSF 365cc BI (US) 10888628033146, Natrelle Inspira SSF 385cc BI (US) 10888628033153, Natrelle Inspira SSF 415cc BI (US) 10888628033160, Natrelle Inspira SSF 450cc BI (US) 10888628033177, Natrelle Inspira SSF 485cc BI (US) 10888628033184, Natrelle Inspira SSF 520cc BI (US) 10888628033191, Natrelle Inspira SSF 560cc BI (US) 10888628033207, Natrelle Inspira SSF 605cc BI (US) 10888628033214, Natrelle Inspira SSF 650cc BI (US) 10888628033221, Natrelle Inspira SSF 695cc BI (US) 10888628033238, Natrelle Inspira SSF 745cc BI (US) 10888628033245, Natrelle Inspira SSF 770cc BI (US) 10888628033252, 7609 SSX/UDI: Natrelle Inspira SSX 200cc BI (US) 10888628033269, Natrelle Inspira SSX 225cc BI (US) 10888628033276, Natrelle Inspira SSX 255cc BI (US) 10888628033283, Natrelle Inspira SSX 285cc BI (US) 10888628033290, Natrelle Inspira SSX 310cc BI (US) 10888628033306, Natrelle Inspira SSX 340cc BI (US) 10888628033313, Natrelle Inspira SSX 375cc BI (US) 10888628033320, Natrelle Inspira SSX 400cc BI (US) 10888628033337, Natrelle Inspira SSX 420cc BI (US) 10888628033344, Natrelle Inspira SSX 445cc BI (US) 10888628033351, Natrelle Inspira SSX 470cc BI (US) 10888628033368, Natrelle Inspira SSX 495cc BI (US) 10888628033375, Natrelle Inspira SSX 525cc BI (US) 10888628033382, Natrelle Inspira SSX 545cc BI (US) 10888628033399, Natrelle Inspira SSX 560cc BI (US) 10888628033405, Natrelle Inspira SSX 580cc BI (US) 10888628033412, Natrelle Inspira SSX 615cc BI (US) 10888628033429, Natrelle Inspira SSX 650cc BI (US) 10888628033436, Natrelle Inspira SSX 700cc BI (US) 10888628033443, Natrelle Inspira SSX 750cc BI (US) 10888628033450, Natrelle Inspira SSX 800cc BI (US) 10888628033467, 7513 SRL/UDI: Natrelle Inspira SRL 110cc BI (US) 10888628006645, Natrelle Inspira SRL 125cc BI (US) 10888628006652, Natrelle Inspira SRL 140cc BI (US) 10888628006669, Natrelle Inspira SRL 170cc BI (US) 10888628006676, Natrelle Inspira SRL 200cc BI (US) 10888628006683, Natrelle Inspira SRL 230cc BI (US) 10888628006690, Natrelle Inspira SRL 260cc BI (US) 10888628006706, Natrelle Inspira SRL 290cc BI (US) 10888628006713, Natrelle Inspira SR

    FDA Recall
    Terminated ·Allergan PLC·Product code FTR·November 6, 2019

    Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel Round Mod 10888628001220, NATRELLE Style 10-270 Gel Round Mod 10888628001237, NATRELLE Style 10-300 Gel Round Mod 10888628001244, NATRELLE Style 10-330 Gel Round Mod 10888628001251, NATRELLE Style 10-360 Gel Round Mod 10888628001268, NATRELLE Style 10-390 Gel Round Mod 10888628001275, NATRELLE Style 10-420 Gel Round Mod 10888628001282, NATRELLE Style 10-450 Gel Round Mod 10888628001299, NATRELLE Style 10-510 Gel Round Mod 10888628001312, NATRELLE Style 10-800 Gel Round Mod 10888628001374, Style 15/UDI: NATRELLE Style 15-158 Gel Round Mod Plus 10888628001381, NATRELLE Style 15-176 Gel Round Mod Plus 10888628001398, NATRELLE Style 15-194 Gel Round Mod Plus 10888628001404, NATRELLE Style 15-213 Gel Round Mod Plus 10888628001411, NATRELLE Style 15-234 Gel Round Mod Plus 10888628001428, NATRELLE Style 15-265 Gel Round Mod Plus 10888628001435, NATRELLE Style 15-286 Gel Round Mod Plus 10888628001442, NATRELLE Style 15-304 Gel Round Mod Plus 10888628001459, NATRELLE Style 15-339 Gel Round Mod Plus 10888628001466, NATRELLE Style 15-371 Gel Round Mod Plus 10888628001473, NATRELLE Style 15-397 Gel Round Mod Plus 10888628001480, NATRELLE Style 15-421 Gel Round Mod Plus 10888628001497, NATRELLE Style 15-457 Gel Round Mod Plus 10888628001503, NATRELLE Style 15-492 Gel Round Mod Plus 10888628001510, NATRELLE Style 15-533 Gel Round Mod Plus 10888628001527, NATRELLE Style 15-575 Gel Round Mod Plus 10888628001534, NATRELLE Style 15-616 Gel Round Mod Plus 10888628001541, NATRELLE Style 15-659 Gel Round Mod Plus 10888628001558, NATRELLE Style 15-700 Gel Round Mod Plus 10888628001565, NATRELLE Style 15-752 Gel Round Mod Plus 10888628001572, Style 20/UDI: NATRELLE Style 20-230 Gel Round High 10888628001633, NATRELLE Style 20-280 Gel Round High 10888628001657, NATRELLE Style 20-300 Gel Round High 10888628001664, NATRELLE Style 20-325 Gel Round High 10888628001671, NATRELLE Style 20-350 Gel Round High 10888628001688, NATRELLE Style 20-375 Gel Round High 10888628001695, NATRELLE Style 20-400 Gel Round High 10888628001701, NATRELLE Style 20-425 Gel Round High 10888628001718, NATRELLE Style 20-450 Gel Round High 10888628001725, NATRELLE Style 20-475 Gel Round High 10888628001732, NATRELLE Style 20-500 Gel Round High 10888628001749, NATRELLE Style 20-550 Gel Round High 10888628001756, NATRELLE Style 20-600 Gel Round High 10888628001763, NATRELLE Style 20-650 Gel Round High 10888628001770, NATRELLE Style 20-700 Gel Round High 10888628001787, NATRELLE Style 20-750 Gel Round High 10888628001794, NATRELLE Style 20-800 Gel Round High 10888628001800, Style 40/UDI: NATRELLE Style 40-160 Gel Round Mod 10888628001855, NATRELLE Style 40-240 Gel Round Mod 10888628001893, NATRELLE Style 40-340 Gel Round Mod 10888628001947, Style 45/UDI: NATRELLE Style 45-120 Gel Round Extra High 10888628002005, NATRELLE Style 45-160 Gel Round Extra High 10888628002012, NATRELLE Style 45-240 Gel Round Extra High 10888628002036, NATRELLE Style 45-280 Gel Round Extra High 10888628002043, NATRELLE Style 45-320 Gel Round Extra High 10888628002050, NATRELLE Style 45-360 Gel Round Extra High 10888628002067, NATRELLE Style 45-400 Gel Round Extra High 10888628002074, NATRELLE Style 45-460 Gel Round Extra High 10888628002081, NATRELLE Style 45-500 Gel Round Extra High 10888628002098, NATRELLE Style 45-550 Gel Round Extra High 10888628002104, NATRELLE Style 45-600 Gel Round Extra High 10888628002111, NATRELLE Style 45-650 Gel Round Extra High 10888628002128, NATRELLE Style 45-700 Gel Round Extra High 10888628002135, NATRELLE Style 45-800 Gel Round Extra High 10888628002142,

    FDA Recall
    Terminated ·Allergan PLC·Product code FTR·November 6, 2019

    Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO PACK PGYBK, V A MED CTR COLUMBIA, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VAMC-NORTHPORT, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED GU TUR BASIN SET PGYBK, V A MED CTR BAY PINES - C, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED ORTHO PACK A&B, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) CARDIOVASCULAR DRAPE, MERITCARE HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, ST. MARY'SMED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) MAJOR CYSTO TRAY, BRYAN LGH MED CENTER EAST, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) URETHRAGRAM TRAY 20/CS, NORTH MISSISSIPPI MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PELVIC EXAM TRAY, BAPTIST MEMORIAL OXFORD, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TUR PACK PGYBK 5/CS, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LABOR AND DELIVERY TRACECART (R), KEESLER MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PHASE ONE DELIVERY TRACECART, TALLAHASSEE MEM REGNL CTR-AMT, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, HOLLAND COMMUNITY HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) GU MINOR, MIDDLESEX MEMORIAL HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, ST ANTHONYS HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) T V H TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LTC/LAP TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LAP GYN TRAY, COFFEE REGIONAL MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) RADICAL PROST TRAY PGYBK, HAYS MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) D&C GYN PACK, HIGH POINTE SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CRYO TRAY PGYBK, MIDTOWN SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, HOUSTON MEDICAL CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, UNIV ARKANSAS MED LITTLE ROCK, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, In

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code LRP·February 7, 2011

    The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF120 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR120 Autotransfusion Reservoir. ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a 1/4 inch. suction port and is connected to a vacuum source. ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. ATF 120 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

    FDA Recall
    Terminated ·Fresenius Kabi, LLC·Product code CAC·March 29, 2010

    The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF 40 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a inch. suction port and is connected to a vacuum source. ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. ATF 40 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

    FDA Recall
    Terminated ·Fresenius Kabi, LLC·Product code CAC·March 29, 2010

    Cathcor/LX/Desktop, System, X-Ray, Angiographic

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·November 27, 2002

    Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

    FDA Enforcement
    Class II ·Terminated·Therasage, LLC.·May 6, 2015

    Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.

    FDA Enforcement
    Class II ·Terminated·Medtronic Perfusion Systems·June 23, 2021

    FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

    FDA Enforcement
    Class II ·Terminated·Therasage, LLC.·May 6, 2015

    FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

    FDA Enforcement
    Class II ·Terminated·Therasage, LLC.·May 6, 2015

    Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·April 29, 2021

    Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-CTR.

    FDA Recall
    Terminated ·Mainline Technology, Inc.·Product code JHI·August 18, 2008

    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 17, 2015

    Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 17, 2014

    TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016