CLASS II Device recall · Reported 15 Oct 2025 · FDA Enforcement Report

NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x recalled

Applied Medical Technology is recalling NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, distributed in Massachusetts, Rhode Island. The recall was initiated on 12 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBox UDI (01)00842071149628(17)280601(10)250711-237, Pouch UDI: (01)00842071149505(17)280701(10)250707-412, (01)00842071149505(17)280601(10)250701-300. Box UDI (01)00842071149628(17)280701(10)250717-425, Pouch UDI: (01)00842071149505(17)280701(10)250710-247, (01)00842071149505(17)280701(10)250710-246. Box UDI (01)00842071149628(17)280601(10)250709-162, Pouch UDI: (01)00842071149505(17)280701(10)250702-222, (01)00842071149505(17)280601(10)250627-420, (01)00842071149505(17)280701(10)250702-412. Box UDI (01)00842071149628(17)280601(10)250710-217, Pouch UDI: (01)00842071149505(17)280701(10)250702-169, (01)00842071149505(17)280701(10)250702-138, (01)00842071149505(17)280701(10)250702-220, (01)00842071149505(17)280601(10)250630-093, (01)00842071149505(17)280601(10)250630-048, (01)00842071149505(17)280601(10)250630-047, (01)00842071149505(17)280601(10)250630-046, (01)00842071149505(17)280701(10)250702-170. Box UDI (01)00842071149628(17)280601(10)250710-307, Pouch UDI: (01)00842071149505(17)280701(10)250707-457, (01)00842071149505(17)280701(10)250702-414, (01)00842071149505(17)280601(10)250701-302, (01)00842071149505(17)280601(10)250701-301, (01)00842071149505(17)280701(10)250702-137. Box UDI (01)00842071149628(17)280601(10)250620-347, Pouch UDI: (01)00842071149505(17)280601(10)250617-066, (01)00842071149505(17)280601(10)250617-067, (01)00842071149505(17)280601(10)250617-101. Box UDI (01)00842071149628(17)280601(10)250626-400, Pouch UDI: (01)00842071149505(17)280601(10)250609-364. Box UDI (01)00842071149628(17)280601(10)250618-493, Pouch UDI: (01)00842071149505(17)280601(10)250609-360, (01)00842071149505(17)280601(10)250604-076, (01)00842071149505(17)280601(10)250611-223, (01)00842071149505(17)280601(10)250612-097, (01)00842071149505(17)280601(10)250609-363, (01)00842071149505(17)280601(10)250609-362. Box UDI (01)00842071149628(17)280501(10)250612-388, Pouch UDI: (01)00842071149505(17)280601(10)250605-139, (01)00842071149505(17)280601(10)250603-078, (01)00842071149505(17)280601(10)250604-383. Box UDI (01)00842071149628(17)280601(10)250616-372, Pouch UDI: (01)00842071149505(17)280601(10)250604-075, (01)00842071149505(17)280601(10)250604-382, (01)00842071149505(17)280601(10)250605-338.
Quantity recalled1780 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0127-2026
FDA event ID
97448
Recalling firm
Applied Medical Technology, Brecksville, OH
Classification
Class II
Status
Completed
Recall initiated
12 Aug 2025
FDA classified
9 Oct 2025
Reported
15 Oct 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

12 Aug 2025Recall initiated by company
9 Oct 2025Classified by FDA+58 days
15 Oct 2025Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-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.

Where it was distributed

US distribution to MA and RI

MassachusettsRhode Island

Questions about this recall

Is NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55 recalled?

Yes. Applied Medical Technology recalled NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55 on 12 Aug 2025. The recall is Class II and its status is Completed. Recall number Z-0127-2026.

Why was it recalled?

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

Which lots are affected?

Box UDI (01)00842071149628(17)280601(10)250711-237, Pouch UDI: (01)00842071149505(17)280701(10)250707-412, (01)00842071149505(17)280601(10)250701-300. Box UDI (01)00842071149628(17)280701(10)250717-425, Pouch UDI: (01)00842071149505(17)280701(10)250710-247, (01)00842071149505(17)280701(10)250710-246. Box UDI (01)00842071149628(17)280601(10)250709-162, Pouch UDI: (01)00842071149505(17)280701(10)250702-222, (01)00842071149505(17)280601(10)250627-420, (01)00842071149505(17)280701(10)250702-412. Box UDI (01)00842071149628(17)280601(10)250710-217, Pouch UDI: (01)00842071149505(17)280701(10)250702-169, (01)00842071149505(17)280701(10)250702-138, (01)00842071149505(17)280701(10)250702-220, (01)00842071149505(17)280601(10)250630-093, (01)00842071149505(17)280601(10)250630-048, (01)00842071149505(17)280601(10)250630-047, (01)00842071149505(17)280601(10)250630-046, (01)00842071149505(17)280701(10)250702-170. Box UDI (01)00842071149628(17)280601(10)250710-307, Pouch UDI: (01)00842071149505(17)280701(10)250707-457, (01)00842071149505(17)280701(10)250702-414, (01)00842071149505(17)280601(10)250701-302, (01)00842071149505(17)280601(10)250701-301, (01)00842071149505(17)280701(10)250702-137. Box UDI (01)00842071149628(17)280601(10)250620-347, Pouch UDI: (01)00842071149505(17)280601(10)250617-066, (01)00842071149505(17)280601(10)250617-067, (01)00842071149505(17)280601(10)250617-101. Box UDI (01)00842071149628(17)280601(10)250626-400, Pouch UDI: (01)00842071149505(17)280601(10)250609-364. Box UDI (01)00842071149628(17)280601(10)250618-493, Pouch UDI: (01)00842071149505(17)280601(10)250609-360, (01)00842071149505(17)280601(10)250604-076, (01)00842071149505(17)280601(10)250611-223, (01)00842071149505(17)280601(10)250612-097, (01)00842071149505(17)280601(10)250609-363, (01)00842071149505(17)280601(10)250609-362. Box UDI (01)00842071149628(17)280501(10)250612-388, Pouch UDI: (01)00842071149505(17)280601(10)250605-139, (01)00842071149505(17)280601(10)250603-078, (01)00842071149505(17)280601(10)250604-383. Box UDI (01)00842071149628(17)280601(10)250616-372, Pouch UDI: (01)00842071149505(17)280601(10)250604-075, (01)00842071149505(17)280601(10)250604-382, (01)00842071149505(17)280601(10)250605-338.

Where was it sold?

US distribution to MA and RI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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