NutraGlide Nasal Feeding Tube
NutraGlide is a nasal feeding tube for delivering nutrition, fluids and medications to the stomach or small intestine. Its lumen gradually widens from the external Y-port toward the…
NutraGlide is a nasal feeding tube for delivering nutrition, fluids and medications to the stomach or small intestine. Its lumen gradually widens from the external Y-port toward the indwelling distal opening.
The dissolvable distal tip exposes the full rounded opening after it dissolves. An optional stylet has a separate water-activated lubricious coating to assist placement.
Listed Item
08FR – 10 FR x 110cm NutraGlide Nasal Feeding Tube with Stylet and ENFit® (Sterile, Pouched), MDR
Connector and Supply Configurations
ENFit and legacy versions differ at the Y-port, with the other tube construction shared. Sterile and nonsterile formats are available for single use. The system supports intermittent or continuous nasogastric or nasoenteric feeding in neonatal, pediatric and adult patients.
25manufacturers in China registered for this device type
279catalogue numbers in this listing
26510(k) clearances naming this product code
13recalls on this code
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | Applied Medical Technology, Inc., United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K202539 |
| Record published | 2025-09-29 |
| Record revised | 2025-05-01 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box (nft-06055-n-i) of 10, box (nft-06055-i) of 10, box (nft-06090-i) of 10, box (nft-06090-n-i) of 10, box (nft-10090-i) of 10, box (nft-10140-n-i) of 10 |
| Sizes | Catheter gauge 5 to 12 Fr; length 38 to 140 cm |
| Distribution end date | 2025-04-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ENFT-10090-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-10140-N-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-06055 | Length 55 cm | In distribution |
| ESNFT-08110-N | Catheter Gauge 10 Fr | In distribution |
| ENFT-05038-N-I | Length 38 cm | In distribution |
| ESNFT-08110-N-I | Length 110 cm | In distribution |
| ENFT-10140 | Catheter Gauge 12 Fr | In distribution |
| ESNFT-08090-N-I | Length 90 cm | In distribution |
| ENFT-10140 | Length 140 cm | In distribution |
| ENFT-10140-N-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05055-I | Length 55 cm | In distribution |
| ENFT-05038-N-I | Length 38 cm | In distribution |
| ESNFT-08140-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-05038-I | Length 38 cm | In distribution |
| ENFT-06055-N-I | Length 55 cm | In distribution |
| ENFT-05055 | Length 55 cm | In distribution |
| ESNFT-06090-N | Length 90 cm | In distribution |
| ESNFT-05090 | Length 90 cm | In distribution |
| ESNFT-06055-I | Catheter Gauge 6 Fr | In distribution |
| ENFT-06090 | Length 90 cm | In distribution |
| ESNFT-08110 | Catheter Gauge 10 Fr | In distribution |
| ESNFT-10090-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-10110 | Catheter Gauge 12 Fr | In distribution |
| ENFT-06090-N | Length 90 cm | In distribution |
| ENFT-08110-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-08140-I | Length 140 cm | In distribution |
| ENFT-05038-N | Length 38 cm | In distribution |
| ENFT-08090-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-08140-N | Catheter Gauge 10 Fr | In distribution |
| ESNFT-08140-N-I | Length 140 cm | In distribution |
| ESNFT-05038 | Length 38 cm | In distribution |
| ESNFT-08110-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-10140-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-08140-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-05038-I | Length 38 cm | In distribution |
| ESNFT-08110-N | Length 110 cm | In distribution |
| ESNFT-05090 | Length 90 cm | In distribution |
| ENFT-08110-N-I | Length 110 cm | In distribution |
| ESNFT-10110-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-06090-N | Length 90 cm | In distribution |
| ENFT-10110-N | Catheter Gauge 12 Fr | In distribution |
| ENFT-08090-N | Length 90 cm | In distribution |
| ESNFT-06090-I | Length 90 cm | In distribution |
| ENFT-05055-N | Length 55 cm | In distribution |
| ESNFT-05038 | Length 38 cm | In distribution |
| ENFT-08090 | Length 90 cm | In distribution |
| ENFT-06055-I | Catheter Gauge 8 Fr | In distribution |
| ESNFT-08110-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-05038 | Length 38 cm | In distribution |
| ESNFT-08140 | Catheter Gauge 10 Fr | In distribution |
| ESNFT-10090-I | Length 90 cm | In distribution |
| ESNFT-05038 | Length 38 cm | In distribution |
| ENFT-08110-I | Length 110 cm | In distribution |
| ESNFT-06055 | Length 55 cm | In distribution |
| ENFT-05055-I | Length 55 cm | In distribution |
| ENFT-10110-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-10140-N | Length 140 cm | In distribution |
| ESNFT-08140 | Catheter Gauge 10 Fr | In distribution |
| ESNFT-05038-I | Length 38 cm | In distribution |
| ENFT-08140-N | Length 140 cm | In distribution |
| ESNFT-10140-N | Catheter Gauge 12 Fr | In distribution |
| ENFT-10110 | Length 110 cm | In distribution |
| ENFT-10140 | Catheter Gauge 12 Fr | In distribution |
| ENFT-08110-N | Catheter Gauge 10 Fr | In distribution |
| ENFT-08140 | Length 140 cm | In distribution |
| ESNFT-10090-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-06090 | Length 90 cm | In distribution |
| ESNFT-10090-N | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05055-I | Length 55 cm | In distribution |
| ESNFT-05090-N-I | Length 90 cm | In distribution |
| ESNFT-10090-N-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-08110 | Catheter Gauge 10 Fr | In distribution |
| ESNFT-10090 | Length 90 cm | In distribution |
| ENFT-10140-N | Catheter Gauge 12 Fr | In distribution |
| ENFT-05038 | Length 38 cm | In distribution |
| ESNFT-08110-I | Catheter Gauge 10 Fr | In distribution |
| ESNFT-06055-N-I | Catheter Gauge 6 Fr | In distribution |
| ESNFT-10110-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-08110 | Catheter Gauge 10 Fr | In distribution |
| ESNFT-06055-N | Catheter Gauge 6 Fr | In distribution |
| ENFT-06055-N | Length 55 cm | In distribution |
| ENFT-06038 | Catheter Gauge 8 Fr | In distribution |
| ESNFT-10140 | Catheter Gauge 12 Fr | In distribution |
| ENFT-08090 | Catheter Gauge 10 Fr | In distribution |
| ENFT-10140-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-10140-N | Length 140 cm | In distribution |
| ESNFT-06038-N-I | Catheter Gauge 8 Fr | In distribution |
| ESNFT-08140-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-06038-N | Catheter Gauge 8 Fr | In distribution |
| ESNFT-10110-N | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05090-I | Length 90 cm | In distribution |
| ENFT-06090-I | Length 90 cm | In distribution |
| ESNFT-05055-N-I | Length 55 cm | In distribution |
| ENFT-08140-N-I | Catheter Gauge 10 Fr | In distribution |
| ESNFT-10140-N-I | Length 140 cm | In distribution |
| ESNFT-05038-I | Length 38 cm | In distribution |
| ENFT-05090-N | Length 90 cm | In distribution |
| ESNFT-08090-N | Length 90 cm | In distribution |
| ESNFT-08090-N-I | Catheter Gauge 10 Fr | In distribution |
| ESNFT-08090 | Catheter Gauge 10 Fr | In distribution |
| ENFT-05090-I | Length 90 cm | In distribution |
| ENFT-08110-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-06090-N-I | Length 90 cm | In distribution |
| ENFT-10110-N-I | Length 110 cm | In distribution |
| ESNFT-06090-N-I | Length 90 cm | In distribution |
| ESNFT-10090 | Catheter Gauge 12 Fr | In distribution |
| ENFT-05038 | Length 38 cm | In distribution |
| ESNFT-10090-N-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05090-I | Length 90 cm | In distribution |
| ENFT-08140-I | Catheter Gauge 10 Fr | In distribution |
| ESNFT-08090 | Length 90 cm | In distribution |
| ESNFT-05038-N-I | Length 38 cm | In distribution |
| ENFT-08140-I | Catheter Gauge 10 Fr | In distribution |
| ESNFT-10090 | Catheter Gauge 12 Fr | In distribution |
| ESNFT-08110-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-10090 | Catheter Gauge 12 Fr | In distribution |
| ENFT-05055-I | Length 55 cm | In distribution |
| ESNFT-08140-N | Catheter Gauge 10 Fr | In distribution |
| ENFT-10090 | Catheter Gauge 12 Fr | In distribution |
| ENFT-08140-N-I | Length 140 cm | In distribution |
| ENFT-05090-N | Length 90 cm | In distribution |
| ENFT-08110-N | Catheter Gauge 10 Fr | In distribution |
| ENFT-10110-I | Length 110 cm | In distribution |
| ENFT-05055-N-I | Length 55 cm | In distribution |
| ENFT-05038-N | Length 38 cm | In distribution |
| ESNFT-05038-N | Length 38 cm | In distribution |
| ESNFT-08140-N | Catheter Gauge 10 Fr | In distribution |
| ESNFT-10110 | Length 110 cm | In distribution |
| ENFT-06090-N | Length 90 cm | In distribution |
| ENFT-08110-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-08090-N | Catheter Gauge 10 Fr | In distribution |
| ESNFT-08090-N | Catheter Gauge 10 Fr | In distribution |
| ENFT-05055-N | Length 55 cm | In distribution |
| ESNFT-05090-N | Length 90 cm | In distribution |
| ESNFT-05055 | Length 55 cm | In distribution |
| ENFT-08140-N | Catheter Gauge 10 Fr | In distribution |
| ESNFT-10140-I | Length 140 cm | In distribution |
| ENFT-08090-N-I | Catheter Gauge 10 Fr | In distribution |
| ESNFT-06055-N-I | Catheter Gauge 6 Fr | In distribution |
| ESNFT-06090 | Length 90 cm | In distribution |
| ESNFT-10140 | Length 140 cm | In distribution |
| ESNFT-06090 | Length 90 cm | In distribution |
| ESNFT-05038-N | Length 38 cm | In distribution |
| ENFT-08110 | Catheter Gauge 10 Fr | In distribution |
| ENFT-06055-I | Length 55 cm | In distribution |
| ENFT-08110-N | Length 110 cm | In distribution |
| ENFT-06055-I | Length 55 cm | In distribution |
| ESNFT-06090-I | Length 90 cm | In distribution |
| ESNFT-08090-N | Catheter Gauge 10 Fr | In distribution |
| ENFT-06055-N-I | Catheter Gauge 8 Fr | In distribution |
| ENFT-06090-N-I | Length 90 cm | In distribution |
| ESNFT-05055-N | Length 55 cm | In distribution |
| ENFT-08110-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-10110-N | Catheter Gauge 12 Fr | In distribution |
| ESNFT-08110-I | Length 110 cm | In distribution |
| ESNFT-10110-N | Catheter Gauge 12 Fr | In distribution |
| ENFT-10090-N-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05090-N-I | Length 90 cm | In distribution |
| ENFT-08090 | Catheter Gauge 10 Fr | In distribution |
| ENFT-06055-I | Catheter Gauge 8 Fr | In distribution |
| ESNFT-06055 | Length 55 cm | In distribution |
| ENFT-10110 | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05090 | Length 90 cm | In distribution |
| ESNFT-06055-N | Catheter Gauge 6 Fr | In distribution |
| ESNFT-05090-N-I | Length 90 cm | In distribution |
| ESNFT-08110-N | Catheter Gauge 10 Fr | In distribution |
| ENFT-06090-I | Catheter Gauge 8 Fr | In distribution |
| ESNFT-06055-N | Catheter Gauge 6 Fr | In distribution |
| ENFT-05090-N-I | Length 90 cm | In distribution |
| ESNFT-10140-N-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-10110-N-I | Length 110 cm | In distribution |
| ENFT-05055 | Length 55 cm | In distribution |
| ENFT-10090-I | Length 90 cm | In distribution |
| ESNFT-10140-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05055-N-I | Length 55 cm | In distribution |
| ESNFT-05055-N | Length 55 cm | In distribution |
| ESNFT-06038 | Catheter Gauge 8 Fr | In distribution |
| ESNFT-05038-N-I | Length 38 cm | In distribution |
| ENFT-05090 | Length 90 cm | In distribution |
| ESNFT-06090-N | Length 90 cm | In distribution |
| ESNFT-08090-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-06038-N-I | Catheter Gauge 8 Fr | In distribution |
| ENFT-05090 | Length 90 cm | In distribution |
| ESNFT-06090-I | Length 90 cm | In distribution |
| ESNFT-06055-I | Catheter Gauge 6 Fr | In distribution |
| ENFT-10090-N-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-06055 | Length 55 cm | In distribution |
| ESNFT-05090-I | Length 90 cm | In distribution |
| ESNFT-06038-I | Catheter Gauge 8 Fr | In distribution |
| ENFT-06055 | Catheter Gauge 8 Fr | In distribution |
| ESNFT-08140-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-05038-N-I | Length 38 cm | In distribution |
| ESNFT-08090-I | Length 90 cm | In distribution |
| ENFT-06090-I | Length 90 cm | In distribution |
| ENFT-10140-N-I | Length 140 cm | In distribution |
| ENFT-05055-I | Length 55 cm | In distribution |
| ESNFT-10140-N-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05038-I | Length 38 cm | In distribution |
| ESNFT-08140-N-I | Catheter Gauge 10 Fr | In distribution |
| ENFT-05090-I | Length 90 cm | In distribution |
| ENFT-10090-N-I | Length 90 cm | In distribution |
| ESNFT-08110 | Length 110 cm | In distribution |
| ENFT-05055-N-I | Length 55 cm | In distribution |
| ESNFT-10110 | Catheter Gauge 12 Fr | In distribution |
| ENFT-10090 | Length 90 cm | In distribution |
| ESNFT-08140-N | Length 140 cm | In distribution |
| ENFT-06090-N-I | Length 90 cm | In distribution |
| ENFT-05090-I | Length 90 cm | In distribution |
| ENFT-10110-N-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-08140 | Length 140 cm | In distribution |
| ESNFT-06090-N | Length 90 cm | In distribution |
| ENFT-06055-N | Catheter Gauge 8 Fr | In distribution |
| ENFT-10110-I | Catheter Gauge 12 Fr | In distribution |
| ESNFT-05055-I | Length 55 cm | In distribution |
| ESNFT-05055-N-I | Length 55 cm | In distribution |
| ESNFT-06090-N-I | Length 90 cm | In distribution |
| ENFT-08090-I | Catheter Gauge 10 Fr | In distribution |
| ESNFT-10090-N-I | Length 90 cm | In distribution |
| ENFT-05055 | Length 55 cm | In distribution |
| ENFT-10090-N | Catheter Gauge 12 Fr | In distribution |
| ESNFT-10090-N | Length 90 cm | In distribution |
| ENFT-05038-N | Length 38 cm | In distribution |
| ENFT-10110 | Catheter Gauge 12 Fr | In distribution |
| ENFT-10090-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-05055-I | Length 55 cm | In distribution |
| ESNFT-08090 | Catheter Gauge 10 Fr | In distribution |
| ENFT-05090-I | Length 90 cm | In distribution |
| ENFT-05090-N | Length 90 cm | In distribution |
| ESNFT-10140 | Catheter Gauge 12 Fr | In distribution |
| ENFT-08140 | Catheter Gauge 10 Fr | In distribution |
| ESNFT-05055-N | Length 55 cm | In distribution |
| ENFT-10090-N | Length 90 cm | In distribution |
| ESNFT-10110-N | Length 110 cm | In distribution |
| ENFT-10110-N | Length 110 cm | In distribution |
| ESNFT-06090-N-I | Length 90 cm | In distribution |
| ENFT-08090-N-I | Length 90 cm | In distribution |
| ESNFT-10090-N | Catheter Gauge 12 Fr | In distribution |
| ESNFT-10110-I | Length 110 cm | In distribution |
| ESNFT-10110-N-I | Catheter Gauge 12 Fr | In distribution |
| ENFT-05090 | Length 90 cm | In distribution |
| ENFT-08090-I | Length 90 cm | In distribution |
| ENFT-05055-N-I | Length 55 cm | In distribution |
| ESNFT-05038-N-I | Length 38 cm | In distribution |
| ESNFT-05055 | Length 55 cm | In distribution |
| ENFT-06055-N | Length 55 cm | In distribution |
| ENFT-06038-I | Catheter Gauge 8 Fr | In distribution |
| ENFT-10140-N | Catheter Gauge 12 Fr | In distribution |
| ENFT-10140-I | Length 140 cm | In distribution |
| ESNFT-05090-N | Length 90 cm | In distribution |
| ENFT-06090 | Catheter Gauge 8 Fr | In distribution |
Showing 250 of 279 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
| MiniACE | Applied Medical Technology, Inc. | 93 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222846 | 2023-12-18 |
| K202539 | 2020-10-29 |
| K183508 | 2019-03-29 |
| K182804 | 2019-03-01 |
| K180026 | 2018-06-01 |
| K170319 | 2017-10-06 |
| K161413 | 2017-02-09 |
| K142971 | 2015-05-26 |
| K123716 | 2013-04-19 |
| K110804 | 2011-10-19 |
| K073034 | 2008-03-14 |
| K043027 | 2004-12-02 |
| K042300 | 2004-10-25 |
| K030784 | 2004-04-01 |
| K012476 | 2001-08-31 |
| K971434 | 1998-08-17 |
| K980305 | 1998-04-16 |
| K972478 | 1998-02-09 |
| K973893 | 1997-12-19 |
| K971757 | 1997-11-07 |
| K961345 | 1996-09-17 |
| K945618 | 1995-10-12 |
| K946140 | 1995-08-28 |
| K923488 | 1995-07-20 |
| K923692 | 1993-05-07 |
| K920894 | 1992-04-28 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Applied Medical Technology, Inc. | 510(k) number | 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | |
| Applied Medical Technology, Inc. | 510(k) number | 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | |
| Applied Medical Technology, Inc. | 510(k) number | 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | |
| Applied Medical Technology, Inc. | 510(k) number | 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | |
| Applied Medical Technology, Inc. | 510(k) number | 2025-10-06 | Class II | Process control | The nasal feeding tube may be occluded | |
| Applied Medical Technology, Inc. | 510(k) number | 2025-08-12 | Class II | Process control | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | 1780 units |
| Applied Medical Technology, Inc. | UDI-DI | 2025-08-12 | Class II | Process control | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | 390 units |
| Applied Medical Technology, Inc. | UDI-DI | 2025-08-12 | Class II | Process control | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | 840 units |
| Applied Medical Technology, Inc. | UDI-DI | 2025-08-12 | Class II | Process control | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. | 200 units |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-05-14 | Class II | Process control | Devices were labelled with the incorrect guidewire labelling. | 74 units | |
| 2017-01-19 | Class III | Employee error | Expired expiration dates are listed on the pouches. | 110 | 2017-12-15 |
| 2017-01-19 | Class III | Employee error | Expired expiration dates are listed on the pouches. | 110 | 2017-12-15 |
| 2016-01-26 | Class II | Employee error | The firm received complaints that the product is shorter in length than indicated on the label. | 20 units | 2016-10-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.