Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
Summary
The FDA issued a Class II for Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube w by Applied Medical Technology Inc. Reason: The nasal feeding tube may be occluded.
Details
Source
Device Recall
External ID
Z-0494-2026
Action Date
2025-11-19
Status
Completed
Category
device
Product Description
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
Lot/Code Info: Box P/N NFT-05055-I, Lot Number 250905-220, exp. 2027-03-01, UDI (01)00842071149628(17)270301(10)250905-220, Pouch P/N ENFT-05055-I, Lot Number 250826-272, exp. 2027-03-01, UDI (01)00842071149505(17)270301(10)250826-272; Box P/N NFT-05055-I, Lot Number 250903-181, exp. 2028-01-01, UDI (01)00842071149628(17)280101(10)250903-181, Pouch P/N ENFT-05055-I, Lot Number 250826-269, exp. 2028-05-01, UDI (01)00842071149505(17)280501(10)250826-269; Box P/N NFT-05055-I, Lot Number 250829-265, exp. 2027-11-01, UDI (01)00842071149628(17)271101(10)250829-265, Pouch P/N ENFT-05055-I, Lot Number 250825-151, exp. 2027-11-01, UDI (01)00842071149505(17)271101(10)250825-151; Box P/N NFT-05055-I, Lot Number 250828-270, exp. 2027-04-01, UDI (01)00842071149628(17)270401(10)250828-270, Pouch P/N ENFT-05055-I, Lot Number 250820-454, exp. 2027-08-01, UDI (01)00842071149505(17)270801(10)250820-454; Box P/N NFT-05055-I, Lot Number 250826-394, exp. 2027-03-01, UDI (01)00842071149628(17)270301(10)250826-394, Pouch P/N ENFT-05055-I, Lot Number 250820-455, exp. 2027-03-01, UDI (01)00842071149505(17)270301(10)250820-455; Box P/N NFT-05055-I, Lot Number 250821-196, exp. 2027-11-01, UDI (01)00842071149628(17)271101(10)250821-196, Pouch P/N ENFT-05055-I, Lot Number 250819-036, exp. 2028-07-01, UDI (01)00842071149505(17)280701(10)250819-036; Box P/N NFT-05055-I, Lot Number 250819-216, exp. 2028-02-01, UDI (01)00842071149628(17)280201(10)250819-216, Pouch P/N ENFT-05055-I, Lot Number 250812-342, exp. 2028-03-01, UDI (01)00842071149505(17)280301(10)250812-342; Box P/N NFT-05055-I, Lot Number 250815-176, exp. 2028-03-01, UDI (01)00842071149628(17)280301(10)250815-176, Pouch P/N ENFT-05055-I, Lot Number 250811-459, exp. 2028-03-01, UDI (01)00842071149505(17)280301(10)250811-459.
Reason for Recall
The nasal feeding tube may be occluded
Distribution
US Nationwide distribution in the states of MA, RI, NC, OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-06
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 148 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-0494-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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