BEUDAMED
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    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    FDA Recall
    Open, Classified ·Remel, Inc·Product code LRG·February 12, 2025

    Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.

    FDA Recall
    Terminated ·Kim's Trading Inc·Product code LPM·May 17, 2010

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Recall
    Terminated ·Ki Mobility Llc·Product code INM·November 19, 2021

    NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code KDQ·July 1, 2010

    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code KDQ·December 23, 2016

    Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CIQ·July 20, 2016

    Atrium Pneumostat Chest Drain Valve, Part Number 16100

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code KDQ·August 26, 2021

    The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.

    FDA Recall
    Terminated ·Stryker Sustainability Solutions·Product code KDQ·November 17, 2015

    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

    FDA Recall
    Open, Classified ·DeRoyal Industries Inc·Product code KDQ·February 9, 2023

    Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the number of liners and lids purchased in one case without the individual boxes. The "H" denotes a single quantity when being ordered.

    FDA Recall
    Open, Classified ·Medline Industries Inc·Product code KDQ·January 31, 2019

    Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code KDQ·December 23, 2016

    The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code KDQ·October 22, 2021

    ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.

    FDA Recall
    Terminated ·Hologic, Inc·Product code KDQ·May 31, 2016

    Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code KDQ·October 18, 2022

    Express Mini 500 Dry Seal Chest Drain, Part Number 16400

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code KDQ·March 1, 2023

    LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KDQ·March 22, 2024

    1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KDQ·March 22, 2024

    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code KDQ·September 5, 2023

    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.

    FDA Recall
    Terminated ·HemoCue AB Kuvettgaten 1 Angelholm Sweden·Product code JIQ·November 7, 2012