BEUDAMED
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    Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·November 10, 2006

    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·November 10, 2006

    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas¿ HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas¿ HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas¿ HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas¿ HPV Test include the following liquid based collection media and collection device: " ThinPrep¿ Pap TestTM PreservCyt¿ Solution " Endocervical Brush/Spatula

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·September 18, 2013

    Celesteion PCA-9000A/2 PET/CT System

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code KPS·May 8, 2015

    Toshiba Aquilion CT System TSX-301A

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015

    Toshiba Aquilion CT System TSX-301C

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015

    Toshiba Aquilion CT System TSX-301B

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015

    Toshiba Aquilion CT System TSX-302A

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015

    Toshiba Aquilion CT System TSX-303A

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015

    Toshiba Aquilion CT System TSX-101A

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·May 8, 2015

    BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code NLH·December 17, 2018

    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197

    FDA Recall
    Terminated ·Stryker Corporation·Product code MBI·July 19, 2019

    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197

    FDA Recall
    Terminated ·Stryker Corporation·Product code MBI·July 19, 2019

    REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code KCY·January 21, 2022

    Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code OWQ·March 27, 2020

    Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

    FDA Recall
    Terminated ·Gentherm Medical, LLC·Product code ILO·November 22, 2021

    Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R BASE OARM 8170000027120 SYSTEM 120V 8170000027120 BASE OARM Bl70000027120R SYSTEM 120V RWK BI70000027120R BASE OARM Bl70000027230 SYSTEM 230V 8170000027230 BASE OARM Bl70000027230R SYSTEM 230V RWK BI70000027230R OARM ASSY BI70000027GER SYS PRODUCT GER BI70000027GER OARM ASSY Bl70000027GERR SYS PRODUCT REFURB BI70000027GERR BASE OARM 8170000028100 SYS lOOV 8170000028100 BASE OARM BI70000028120 SYS 120V 8170000028120 BASE OARM BI70000028120R 3RD EDIT REFURB BI70000028120R BASE OARM BI70000028230 SYS 230V BI70000028230 BASE OARM BI70000028230R 3RD EDIT REFURB Bl70000028230R Product Usage: The 0-arrn Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomi~ structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OXO·May 1, 2019

    Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sulz a.N. Germany Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator.

    FDA Recall
    Terminated ·VBM Medical Inc.·Product code BTO·May 9, 2011

    Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTO·November 28, 2011

    Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BTO·November 28, 2011