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U.S. Department of Health and Human Services

Class 2 Device Recall Applied Medical Technology, Inc. Nutraglide

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 Class 2 Device Recall Applied Medical Technology, Inc. Nutraglidesee related information
Date Initiated by FirmOctober 06, 2025
Date PostedNovember 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0494-2026
Recall Event ID 97804
510(K)NumberK202539 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductApplied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
Code Information 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.
Recalling Firm/
Manufacturer		 Applied Medical Technology Inc
8006 Katherine Blvd
Brecksville OH 44141-4202
For Additional Information ContactDan Filler
440-262-2526
Manufacturer Reason
for Recall		The nasal feeding tube may be occluded
FDA Determined
Cause 2		Process control
ActionApplied Medical Technology, Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 10/06/2025 via certified mail. The notice explained the issue, potential risk to health, and requested the consignee quarantine the affected product, complete and return the acknowledgement, and contact Applied Medical Technology, Inc. either by telephone at 440-717-4000 or via email at cs@appliedmedical.net to arrange for the return of the affected product. Those who further distributed the product were directed to notify those to whom the product was transferred of this recall. For questions or concerns, contact: Customer Service, 440-717-4000 (tel), 440-717-4200 (fax), cs@appliedmedical.net (email). Hours of operation 8:30 A - 5:00 P, Eastern time
DistributionUS Nationwide distribution in the states of MA, RI, NC, OH.
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.
510(K) Database510(K)s with Product Code = KNT
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