BEUDAMED
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    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024

    Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00

    FDA Recall
    Open, Classified ·Mindray DS USA, Inc. dba Mindray North America·Product code BSZ·July 22, 2024

    Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00

    FDA Recall
    Open, Classified ·Mindray DS USA, Inc. dba Mindray North America·Product code BSZ·July 22, 2024

    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00

    FDA Recall
    Open, Classified ·Mindray DS USA, Inc. dba Mindray North America·Product code BSZ·July 22, 2024

    Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00

    FDA Recall
    Open, Classified ·Mindray DS USA, Inc. dba Mindray North America·Product code BSZ·July 22, 2024

    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.

    FDA Recall
    Open, Classified ·Ortho Kinematics, Inc·Product code LLZ·January 11, 2017

    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

    FDA Recall
    Open, Classified ·Inspire Medical Systems Inc.·Product code MNQ·May 11, 2026

    The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

    FDA Recall
    Open, Classified ·BigTree Sales Inc.·Product code RHP·August 29, 2025

    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE

    FDA Recall
    Open, Classified ·Immuno-Mycologics, Inc·Product code GMI·February 10, 2025

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    FDA Recall
    Open, Classified ·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    FDA Recall
    Open, Classified ·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    FDA Recall
    Open, Classified ·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code HGM·October 24, 2025

    Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code NJK·December 23, 2021

    Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022

    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022

    Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022