BEUDAMED
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    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

    FDA Recall
    Terminated ·Gyrus Medical, Inc·Product code GEI·July 24, 2013

    MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).

    FDA Recall
    Terminated ·DiaSorin Molecular LLC·Product code PLO·May 12, 2020

    MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.

    FDA Recall
    Terminated ·DiaSorin Molecular LLC·Product code PGI·May 12, 2020

    MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.

    FDA Recall
    Terminated ·DiaSorin Molecular LLC·Product code OQO·May 12, 2020

    VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LGD·March 23, 2018

    Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) Adhesive Remover Wipes, component 050-0415; b) Perineze Perineal Witch Hazel Pad, component 505040A c) 24" Infant Tape Measure, component 30942P; d) Triple Dye Drug, 10 unit dose, component PM1022; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

    FDA Recall
    Terminated ·Cardinal Health·Product code LRP·September 30, 2011

    Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) 24" Infant Tape Measure, component 30942P; b) Silicone Tubing, component SFM3-4450; c) Triple Dye Drug, 10 unit dose, component PM1022; d) Assembly Swabstick, component PS004; e) 18x26 Poly Lined Towel, component 8580Z; f) Disposable Vein Stripper, component 63-0431; g) Cotton Glove, Large, White, PR, NS, component 1051; h) Cotton Glove, Medium, White, PR, NS, component 1051M; i) 6 Inch Metric-Inch Ruler, component 18C-Thru; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

    FDA Recall
    Terminated ·Cardinal Health·Product code LRO·September 30, 2011

    The PREVI Color Gram dyes are used with the PREVI Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI Color Gram instrument sprays the PREVI Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI Color Gram platform that is also indicated on the reagent label. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code KPA·March 23, 2018

    SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

    FDA Recall
    Terminated ·Sam Medical Products·Product code NAD·January 28, 2022

    Plum Duo Infusion System, List Number: 400020401

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FRN·July 11, 2025

    Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.

    FDA Recall
    Terminated ·Remel Inc·Product code JSK·January 24, 2014

    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

    FDA Recall
    Terminated ·Airways Development LLC·Product code BYE·September 24, 2015

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000 501, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.

    FDA Recall
    Terminated ·Westmed, Inc.·Product code BYE·January 15, 2019

    Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DQE·July 9, 2021

    Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.

    FDA Recall
    Terminated ·Westmed, Inc.·Product code BYE·January 15, 2019

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007