Class 2 Device Recall Applied Medical Technology, Inc.

• Date Initiated by Firm: August 12, 2025
• Date Posted: October 09, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0127-2026
• Recall Event ID: 97448
• 510(K)Number: K202539
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Applied Medical Technology Inc; 8006 Katherine Blvd; Brecksville OH 44141-4202
• For Additional Information Contact: Dan 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: Process control
• Action: AMT 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 Commerce: 1780 units
• Distribution: US distribution to MA and RI
• Total Product Life Cycle: TPLC 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.

• 510(K) Database: 510(K)s with Product Code = KNT