BEUDAMED
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    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc. Medina, NY 14103 ** Serial Number: XXXXXX. To be used in a healthcare facility in an IV pole mounted configuration or carried by the user in an ambulatory manner.

    FDA Recall
    Terminated ·Sigma International General Medical Apparatus, Llc·Product code FRN·September 15, 2010

    Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.

    FDA Recall
    Terminated ·Medical Industries America Inc·Product code CAF·September 7, 2004

    ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers. W1801R-Red, UPC 7 54756 91803 3 all serial numbers. The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles. Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds. Warranty Card: "...lifetime of the original purchaser...". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser.

    FDA Recall
    Terminated ·Essential Medical Supply, Inc.·Product code ITJ·December 21, 2009

    Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 603 Queensbury, NY 12804 USA --- COMMON/USUAL NAME - Continuous flush catheter; CLASSIFICATION NAME: Continuous flush catheter; Device Listing # D069932 Benephit Infusion Systems are intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries. The Benephit Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit Infusion Systems are also indicated to facilitate TRT in patients who have demonstrated symptoms of acute kidney injury, and whom arterial catheterization for TRT is feasible.

    FDA Recall
    Terminated ·Angiodynamics Worldwide Headquarters·Product code KRA·December 5, 2011

    Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009

    Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4 channel, 28 cm length, 1/8" trocar, contains 10, sterile, 100cc S-Vac silicone bulb evacuator, Sterion Inc., Ham Lake, MN; REF 332263. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing.

    FDA Recall
    Terminated ·Aspen Surgical Products, Inc.·Product code GCY·April 13, 2009

    Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code LRO·December 20, 2019

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    FDA Recall
    Terminated ·B Braun Medical, Inc.·Product code FRN·October 31, 2012

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Recall
    Terminated ·Tenex Health Inc·Product code LFL·April 14, 2014

    Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021

    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477

    FDA Recall
    Terminated ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code KWQ·April 26, 2021