Z-0497-2026Class II
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF...
Applied Medical Technology Inc / initiated 2025-10-06 / Completed / root cause: manufacturing process
Applied Medical Technology Inc began a recall of Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I on . FDA classified it as Class II and gives the reason as "The nasal feeding tube may be occluded". As of , the recall status on record is Completed, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0497-2026
- Classification
- Class II
- Status
- Completed
- Initiated
- Posted
- Recalling firm
- Applied Medical Technology Inc
- Product
- Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I
- Product code
- KNT Tubes, Gastrointestinal (And Accessories)
- Reason for recall
- The nasal feeding tube may be occluded
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Applied 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 [email protected] 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), [email protected] (email). Hours of operation 8:30 A - 5:00 P, Eastern time
- Distribution
- US Nationwide distribution in the states of MA, RI, NC, OH.
- Product codes and lots
- Box P/N NFT-06055-I, Lot Number 250825-149, exp. 2028-02-01, UDI (01)00842071149123(17)280201(10)250825-149, Pouch P/N ENFT-06055-I, Lot Number 250812-391, exp. 2028-03-01, UDI (01)00842071149048(17)280301(10)250812-391
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0494-2026 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-0495-2026 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-0496-2026 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-0497-2026 | Class II | Completed | Voluntary: Firm initiated | ||
| Z-0498-2026 | Class II | Completed | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
