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U.S. Department of Health and Human Services

Class 2 Device Recall Applied Medical Technology, Inc.

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 Class 2 Device Recall Applied Medical Technology, Inc.see related information
Date Initiated by FirmAugust 12, 2025
Date PostedOctober 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0130-2026
Recall Event ID 97448
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductNutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-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.
Code Information Box UDI (01)00842071149161(17)280501(10)250616-082, Pouch UDI (01)00842071149086(17)280601(10)250604-073, (01)00842071149086(17)280601(10)250604-377. Box UDI (01)00842071149161(17)280601(10)250618-317, Pouch UDI (01)00842071149086(17)280601(10)250609-271, (01)00842071149086(17)280601(10)250610-219.
Recalling Firm/
Manufacturer		 Applied Medical Technology Inc
8006 Katherine Blvd
Brecksville OH 44141-4202
For Additional Information ContactDan Filler
440-7174000
Manufacturer Reason
for Recall		The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
FDA Determined
Cause 2		Process control
ActionAMT issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 8/12/2025 via USPS certified mail. The notice explained the issue, risk to health and requested the following: ACTIONS TO BE TAKEN: CUSTOMER OR USER: Applied Medical Technology, Inc. requests that customers IMMEDIATELY TAKE THE FOLLOWING ACTIONS: " Examine your inventory and isolate/quarantine pending return of the product subject to this recall. " Do not use any device subject to this recall. " Complete and return to Applied Medical Technology, Inc. the enclosed RECALL NOTIFICATION ACKNOWLEDGMENT via fax or send by mail. " Please contact Applied Medical Technology, Inc. either by phone at 440-717-4000, or via email at cs@appliedmedical.net, to make arrangements for the return of any devices related to this recall. Include the product, all of its components, and any available packaging and labeling associated with the device.
Quantity in Commerce200 units
DistributionUS distribution to MA and RI
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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