NutraGlide Nasal Feeding Tubes recalled due to distal tip detachment risk
Applied Medical Technology is recalling 840 units of NutraGlide Nasal Feeding Tubes distributed in Massachusetts and Rhode Island because the distal tips may detach at lower than expected forces.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a defect that could prevent proper function, but no illnesses or injuries have been reported in the source. The FDA Class II classification indicates moderate concern. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Applied Medical Technology Inc is recalling 840 units of NutraGlide Nasal Feeding Tubes with Stylet and ENFit (5 F - 8 F x 55, REF E NRT-06055-I). The nasal feeding tubes are devices placed through the nose and ending in the stomach or intestine, used for administering nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
The recall was initiated because the distal tips of the feeding tubes may detach at lower than expected forces. This defect could prevent proper delivery of nutrition and medications to patients who depend on these devices.
The affected units were distributed to hospitals and medical facilities in Massachusetts and Rhode Island. Specific lot codes are identified by UDI (Unique Device Identifier) numbers on the packaging. Healthcare providers and patients should check whether their supplies match the recalled lot numbers provided in the recall notice.
Healthcare providers should contact Applied Medical Technology Inc for replacement units or further guidance. Patients and caregivers using this product should consult their healthcare provider about next steps.
The recalled product
- Product
- NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-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
- Manufacturer
- Applied Medical Technology Inc
- Category
- Medical Device — Feeding Tubes
- Hazard
- distal-tip-detachment
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Box UDI (01)00842071149123(17)280601(10)250711-319
- Pouch UDI: (01)00842071149048(17)280601(10)250627-421
- Pouch UDI: (01)00842071149048(17)280601(10)250627-422
- (01)00842071149048(17)280601(10)250627-423
- Pouch UDI: (01)00842071149048(17)280601(10)250612-094
- (01)00842071149048(17)280601(10)250617-197
- Pouch UDI: (01)00842071149048(17)280601(10)250623-386
- (01)00842071149048(17)280601(10)250623-388
- Pouch UDI: (01)00842071149048(17)280601(10)250624-271
- (01)00842071149048(17)280601(10)250619-353
- (01)00842071149048(17)280601(10)250623-389
- Pouch UDI: (01)00842071149048(17)280601(10)250610-229.
Distribution
Distributed in 2 states:
- MA
- RI
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