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    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

    Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. Medline Item Numbers 10135910RH 10135936RH

    FDA Recall
    Open, Classified ·Product code OWQ·July 31, 2025

    Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A

    FDA Recall
    Open, Classified ·Sterilmed, Inc.·Product code OWQ·October 8, 2025

    Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A

    FDA Recall
    Open, Classified ·Sterilmed, Inc.·Product code OWQ·October 8, 2025

    Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH

    FDA Recall
    Open, Classified ·Product code OWQ·December 22, 2025

    Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554

    FDA Recall
    Open, Classified ·Product code OWQ·December 22, 2025

    Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.

    FDA Recall
    Terminated ·STERILMED, INC.·Product code OWQ·September 24, 2014

    Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

    FDA Recall
    Open, Classified ·Product code OWQ·December 22, 2025

    NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901

    FDA Recall
    Terminated ·Northeast Scientific Inc.·Product code OWQ·April 26, 2021

    Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH

    FDA Recall
    Open, Classified ·Product code OWQ·July 31, 2025

    ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·February 12, 2008

    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·May 8, 2012

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Recall
    Terminated ·I-Flow LLC·Product code BSO·June 1, 2012

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Recall
    Terminated ·I-Flow LLC·Product code BSO·June 1, 2012

    ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MED·March 27, 2007

    On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·February 14, 2008

    I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. It is a controller that allows the user to regulate the amount of medication that is dispensed.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·April 15, 2011

    ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.

    FDA Recall
    Terminated ·Acrymed Incorporated·Product code FRO·June 30, 2008

    Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009