BEUDAMED
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    PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code ORA·May 22, 2023

    Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02

    FDA Recall
    Terminated ·Philips Medical Systems·Product code DPS·October 13, 2004

    ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NCF·June 30, 2017

    Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·October 1, 2014

    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NCF·June 30, 2017

    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 2, 2023

    Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.

    FDA Recall
    Terminated ·InfuTronix LLC·Product code FRN·May 28, 2019

    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

    FDA Recall
    Terminated ·Philips North America, LLC·Product code DSI·June 8, 2020

    Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000

    FDA Recall
    Terminated ·Cardinal Health·Product code FCG·August 28, 2009

    ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

    FDA Recall
    Terminated ·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DQX·March 30, 2015

    PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

    FDA Recall
    Terminated ·Bard Access Systems Inc.·Product code LJS·December 28, 2017

    Ruggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set.

    FDA Recall
    Terminated ·J. Jamner Surgical Instruments, Inc.·Product code FWZ·April 24, 2006

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Recall
    Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015

    ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.

    FDA Recall
    Terminated ·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DQX·October 28, 2015

    Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.

    FDA Recall
    Terminated ·Carestream Health, Inc.·Product code MQB·June 12, 2012

    Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code IYN·October 16, 2020

    CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019

    CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·October 21, 2019