BEUDAMED
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    JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set.

    FDA Recall
    Terminated ·J. Jamner Surgical Instruments, Inc.·Product code KDC·November 14, 2006

    Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 23, 2007

    CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 10, 2022

    CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 10, 2022

    CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 10, 2022

    Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067

    FDA Recall
    Terminated ·Precision Medical, Inc.·Product code BYJ·October 4, 2006

    CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 10, 2022

    Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·December 4, 2019

    Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo Cardiovalvular Systems, Ann Arbor, MI 48103

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code KRL·September 19, 2007

    NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code OLO·October 27, 2022

    HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: 1) Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. 2) Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. The HomeChoice APD system and HomeChoice Pro APD system are the same in operation, except for the Pro Card and modem features that are only available with the HomeChoice Pro APD system. The Pro Card feature stores prescription and therapy data. The data can be transferred between your cycler and your clinician. The two systems use the same disposable sets and solutions. They perform the same therapies the same way.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·January 14, 2015

    NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H7493927608400, NC EMERGE MR OUS 4.00MM X 8MM; 4. REF/Catalog No. H7493927612200, NC EMERGE MR OUS 2.00MM X 12MM; 5. REF/Catalog No. H7493926712250, NC EMERGE MR US 2.50MM X 12MM; 6. REF/Catalog No. H7493927612250, NC EMERGE MR OUS 2.50MM X 12MM; 7. REF/Catalog No. H7493926712270, NC EMERGE MR US 2.75MM X 12MM; 8. REF/Catalog No. H7493926712320, NC EMERGE MR US 3.25MM X 12MM; 9. REF/Catalog No. H7493927612350, NC EMERGE MR OUS 3.50MM X 12MM; 10. REF/Catalog No. H7493926712400, NC EMERGE MR US 4.00MM X 12MM; 11. REF/Catalog No. H7493927612500, NC EMERGE MR OUS 5.00MM X 12MM; 12. REF/Catalog No. H7493927615270, NC EMERGE MR OUS 2.75MM X 15MM; 13. REF/Catalog No. H7493926715300, NC EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493927615300, NC EMERGE MR OUS 3.00MM X 15MM; 15. REF/Catalog No. H7493927615320, NC EMERGE MR OUS 3.25MM X 15MM; 16. REF/Catalog No. H7493926715350, NC EMERGE MR US 3.50MM X 15MM.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·December 4, 2019

    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM; 5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm; 6. REF/Catalog No. H7493918912300, EMERGE MR US 3.00MM X 12MM; 7. REF/Catalog No. H7493919312300, EMERGE MR, OUS 3.00mm X 12mm; 8. REF/Catalog No. H7493918915150, EMERGE MR US 1.50MM X 15MM; 9. REF/Catalog No. H7493919315150, EMERGE MR, OUS 1.50mm X 15mm; 10. REF/Catalog No. H7493918915200, EMERGE MR US 2.00MM X 15MM, 11. REF/Catalog No. H7493919315200, EMERGE MR, OUS 2.00mm X 15mm; 12. REF/Catalog No. H7493919315250, EMERGE MR, OUS 2.50mm X 15mm; 13. REF/Catalog No. H7493918915300, EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493919315300, EMERGE MR, OUS 3.00mm X 15mm; 15. REF/Catalog No. H7493918915350, EMERGE MR US 3.50MM X 15MM; 16. REF/Catalog No. H7493919315350, EMERGE MR, OUS 3.50mm X 15mm; 17. REF/Catalog No. H7493919320200, EMERGE MR, OUS 2.00mm X 20mm; 18. REF/Catalog No. H7493919320250, EMERGE MR, OUS 2.50mm X 20mm; 19. REF/Catalog No. H7493919320300, EMERGE MR, OUS 3.00mm X 20mm; 20. REF/Catalog No. H7493919415120, EMERGE PUSH MR, OUS 1.20mm X 15mm.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·December 4, 2019

    Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BYD·December 3, 2015

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    FDA Recall
    Terminated ·AB ULAX Merkuriusgatan 8 Motala Sweden·Product code BYD·September 4, 2020

    Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .

    FDA Recall
    Terminated ·Engineered Medical Systems, Inc·Product code BSJ·September 12, 2011

    Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BYD·July 13, 2004

    MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BYD·January 12, 2015

    MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BYD·December 3, 2015

    Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.

    FDA Recall
    Terminated ·Atos Medical AB Kraftgatan·Product code BYD·March 29, 2021