NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tub
Summary
The FDA issued a Class II for NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-0 by Applied Medical Technology Inc. Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces..
Details
Source
Device Recall
External ID
Z-0129-2026
Action Date
2025-10-15
Status
Completed
Category
device
Product 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.
Lot/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.
Quantity Affected: 840 units
Reason for Recall
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Distribution
US distribution to MA and RI
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-12
Company
Brecksville, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Applied Medical Technology Inc has 15 FDA actions in our database, including 11 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Applied Medical Technology Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Applied Medical Technology Inc have FDA actions?
Applied Medical Technology Inc has 15 FDA actions in our database, including 11 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0129-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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