Class 2 Device Recall Nasal Jejunal Feeding Tube

• Date Initiated by Firm: December 15, 2025
• Date Posted: February 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1298-2026
• Recall Event ID: 98274
• 510(K)Number: K043203
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
• Code Information: Lot Code:W4904253, W4886945, W4880750 UDI: 10827002223018
• FEI Number: 1037905
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc.; 4900 Bethania Station Rd; Winston Salem NC 27105-1203
• For Additional Information Contact: Cook Medical Customer Relations; 800-4574500
• Manufacturer Reason for Recall: Nasal feeding tube packaged without the nasal transfer tube component.
• FDA Determined Cause: Employee error
• Action: On January 5, 2026, Cook Endoscopy issued a Urgent Medical Device Recall Notification to affected consignees via E-Mail. Cook Endoscopy asked consignees to take the following actions: 1. Examine inventory immediately to determine if you have affected product(s). If so, quarantine any affected products that remain unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a signed copy of the Acknowledgement and Receipt Form. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand and email the completed form to ausrecalls@cookmedical.com. 4. Please share this notice with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected products have been transferred.
• Quantity in Commerce: 60 units
• Distribution: International distribution to the country of Australia.
• 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