BEUDAMED
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    MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code LKK·June 7, 2013

    MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code LKK·June 7, 2013

    Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HWC·October 1, 2019

    Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code GFF·January 14, 2019

    iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HSX·October 3, 2017

    SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code FLS·April 23, 2009

    Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code FLS·October 15, 2007

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Enforcement
    Class II ·Terminated·FMS, Finapres Medical Systems BV·August 15, 2012

    Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code FCS·May 9, 2008

    SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FAS·January 4, 2021

    HF Cable WA00014A, Endoscopic electrosurgical unit and accessories

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FAS·November 3, 2016

    C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code FAS·October 12, 2016

    SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FAS·January 4, 2021

    SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FAS·January 4, 2021

    SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FAS·January 4, 2021

    Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code FCS·May 9, 2008

    Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code FAS·April 17, 2018

    Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

    FDA Recall
    Terminated ·Cook Inc.·Product code FCS·March 7, 2017

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Recall
    Terminated ·FMS, Finapres Medical Systems BV Paasheuvelweg 34A 1105 BJ Amsterdam Netherlands·Product code DXN·July 6, 2012

    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

    FDA Recall
    Terminated ·TERRIFIC CARE LLC 61 Willet St Bldg A-1, Fl 2 Passaic NJ 07055-1971·Product code GJS·December 20, 2018