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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

AMT Mini Enteral Extension Sets Recalled for Incorrect ENFit Connections

Agency Publication Date: January 7, 2025
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Summary

Applied Medical Technology Inc is recalling 100 units of the AMT Mini Enteral Extension Set (Model E6-1222) because the devices were manufactured with ENFit connections when they should have had non-ENFit connections. Because ENFit connectors are only compatible with other ENFit devices, these recalled sets will not fit standard non-ENFit equipment, which can lead to delays in feeding or medication delivery. If you have these feeding sets, you should stop using them and contact your healthcare provider or the manufacturer for a replacement.

Risk

The incorrect connectors prevent the feeding set from attaching to standard equipment, potentially causing an interruption in nutrition or medication administration. No injuries or incidents have been reported to date in connection with this defect.

What You Should Do

  1. This recall affects the AMT Mini Enteral Extension Set (Model E6-1222), 12" Right Angle Feeding Set with Y-Port, specifically those labeled with lot number 240424-628.
  2. Identify your product by checking the label for Model Number E6-1222, Lot Number 240424-628, and an expiration date of 2027-04-01.
  3. Stop using the recalled feeding sets immediately as they will not properly connect to non-ENFit devices.
  4. Return the product to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Applied Medical Technology Inc for further instructions.
  5. Call the FDA at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port
Model / REF:
E6-1222
Lot Numbers:
240424-628 (Exp. 2027-04-01)
UDI:
00842071107086

Units were manufactured with ENFit connections instead of non-ENFit connections.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95881
Status: Resolved
Manufacturer: Applied Medical Technology Inc
Sold By: Healthcare facilities; Medical supply distributors
Manufactured In: United States
Units Affected: 100
Distributed To: California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.