BEUDAMED
    FDA Enforcement Class II Completed

    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.

    Recall: Z-0129-2026 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0129-2026
    Event ID
    97448
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Applied Medical Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2025
    Initiation Date
    August 12, 2025
    Classification Date
    October 9, 2025
    Address
    8006 Katherine Blvd, Brecksville, OH, 44141-4202, United States

    Description

    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.

    Reason

    The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.

    Code Info

    Box UDI (01)00842071149123(17)280601(10)250711-319, Pouch UDI: (01)00842071149048(17)280601(10)250627-421, (01)00842071149048(17)280601(10)250627-424. Box UDI (01)00842071149123(17)280601(10)250709-071, Pouch UDI: (01)00842071149048(17)280601(10)250627-422, (01)00842071149048(17)280601(10)250627-423, (01)00842071149048(17)280601(10)250627-130. Box UDI (01)00842071149123(17)280601(10)250623-205, Pouch UDI: (01)00842071149048(17)280601(10)250612-094, (01)00842071149048(17)280601(10)250617-197, (01)00842071149048(17)280601(10)250610-228. Box UDI (01)00842071149123(17)280601(10)250625-594, Pouch UDI: (01)00842071149048(17)280601(10)250623-386, (01)00842071149048(17)280601(10)250623-388, (01)00842071149048(17)280601(10)250619-426. Box UDI (01)00842071149123(17)280601(10)250626-238, Pouch UDI: (01)00842071149048(17)280601(10)250624-271, (01)00842071149048(17)280601(10)250619-353, (01)00842071149048(17)280601(10)250623-389, (01)00842071149048(17)280601(10)250619-425. Box UDI (01)00842071149123(17)280601(10)250626-342, Pouch UDI: (01)00842071149048(17)280601(10)250624-270. Box UDI (01)00842071149123(17)280601(10)250616-344, Pouch UDI: (01)00842071149048(17)280601(10)250610-229.

    Distribution

    US distribution to MA and RI

    Quantity

    840 units