CLASS II Device recall · Reported 15 Jan 2025 · FDA Enforcement Report
AMT Mini Enteral Extension Set recalled by Applied Medical Technology
Applied Medical Technology is recalling AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port, distributed in 18 states. The recall was initiated on 26 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0819-2025
- FDA event ID
- 95881
- Recalling firm
- Applied Medical Technology, Brecksville, OH
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 26 Nov 2024
- FDA classified
- 7 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Nov 2024 | Recall initiated by company | |
| 7 Jan 2025 | Classified by FDA | +42 days |
| 15 Jan 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
Product as listed by the FDA
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Where it was distributed
US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA
CaliforniaConnecticutFloridaGeorgiaIllinoisMassachusettsMarylandMissouriNorth CarolinaNew JerseyNew YorkOhioOklahomaPennsylvaniaSouth CarolinaTexasVirginiaWashington
Questions about this recall
Why was it recalled?
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
Which lots are affected?
Lot Code: Model No: E6-1222 UDI-DI: (01)00842071107086(17)270401(10)240424-628 Lot number: 240424-628 Exp. Date: 2027-04-01
Where was it sold?
US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Applied Medical Technology
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|---|---|---|---|---|---|
| Device | CLASS II | NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
| Device | CLASS II | NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit recalled | Applied Medical Technology | Other | Nationwide |
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