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    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION 435428-01 M001273030 FLEXIMA VSCL REG 12FR/35CM M001273040 FLEXIMA VSCL REG 14FR/35CM M001273090 FLEXIMA VSDC REG LOOP 12/35KIT M001273100 FLEXIMA VSDC REG LOOP 14/35KIT M001273150 FLEXIMA VSCL FIRM 12FR/35CM M001273160 FLEXIMA VSCL FIRM 14FR/35CM M001273210 FLEXIMA VSDC FIRM LOOP 12/35 M001273220 FLEXIMA VSDC FIRM LOOP 14/35 Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271240 FLEXIMA APDL FIRM 10F/25CM M001271310 FLEXIMA APDL FIRM 6.3F/25CM M001271320 FLEXIMA APDL FIRM 8F/25CM M001271330 FLEXIMA APDL REG 6.3F/25CM M001271340 FLEXIMA APDL REG 8F/25CM M001271350 FLEXIMA APDL REG 10F/25CM M001271380 FLEXIMA APDL REG 12F/25CM M001271390 FLEXIMA APDL REG 14F/25CM M001271460 FLEXIMA QUICKSTICK LL 8FR M001271470 FLEXIMA QUICKSTICK LL 10FR M001275060 APDTL/7.3FR FLEXIMA SINGLE TT M001275080 APDLTL/7.3FR FLEXIMA SINGLE TT M001281340 FLEXIMA APDL 8/25 TT M001281350 FLEXIMA APDL 10/25 TT M001281380 FLEXIMA APDL 12/25 TT M001281390 FLEXIMA APDL 14/25 TT M001271960 FLEXIMA APDL 8FR REG KIT M001271970 FLEXIMA APDL 10FR REG KIT M001271980 FLEXIMA APDL 8FR FIRM KIT M001271990 FLEXIMA APDL 10FR FIRM KIT M001275070 APDTL/7.3FR FLEXIMA KIT TT M001275010 APDLTL/7.3 FLEXIMA FIRM SINGLE M001275090 APDLTL/7.3FR FLEXIMA KIT TT M001275030 FLEXIMA APDLTL/7/30 STAND KIT M001275050 FLEXIMA APDLTL/7/30 DELUXE KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271770 FLEXIMA NEPH FIRM 8F/25CM M001271780 FLEXIMA NEPH FIRM 10F/25CM M001271790 FLEXIMA NEPH REG 8F/25CM M001271800 FLEXIMA NEPH REG 10F/25CM M001271810 FLEXIMA NEPH REG 12F/25CM M001271820 FLEXIMA NEPH REG 14F/25CM M001271830 FLEXIMA NEPH SOFT 10F/25CM M001271840 FLEXIMA NEPH SOFT 12F/25CM M001271850 FLEXIMA NEPH SOFT 14F/25CM M001281790 FLEXIMA NEPHROSTOMY 8/25 TT M001281800 FLEXIMA NEPHROSTOMY 10/25 TT M001281810 FLEXIMA NEPHROSTOMY 12/25 TT M001281820 FLEXIMA NEPHROSTOMY 14/25 TT M001271860 FLEXIMA NEPH 8F/25CM REG KIT M001271870 FLEXIMA NEPH 10F/25CM REG KIT M001271880 FLEXIMA NEPH 12F/25CM REG KIT M001271890 FLEXIMA NEPH 14F/25CM REG KIT M001271900 FLEXIMA NEPH 8F/25CM FIRM KIT M001271910 FLEXIMA NEPH 10F/25CM FIRM KIT M001281650 FLEXIMA NEPH 8/25 TEMP TIP KIT M001281660 FLEXIMA NEPH/10/25 TEMPTIP KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FFA·September 21, 2006

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·December 3, 2014

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·December 3, 2014

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·November 5, 2014

    MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·October 12, 2016

    MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DYB·September 8, 2016

    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·November 5, 2014

    Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 Product Usage: Tracheal tube/airway management

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTR·July 30, 2019

    Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.

    FDA Recall
    Terminated ·Stardental Division·Product code EFA·December 1, 2006

    Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.

    FDA Recall
    Terminated ·Dental EZ Group Star Dental Division·Product code EFA·June 13, 2014

    Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free

    FDA Recall
    Terminated ·Dental EZ Stardental Division·Product code EFA·August 11, 2010

    Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FAF·April 30, 2010

    Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 Product Usage: Tracheal tube/airway management

    FDA Enforcement
    Class I ·Terminated·Teleflex Medical·September 18, 2019