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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/Surgical Equipment

Applied Medical Technology Inc: Devices were labelled with the incorrect guidewire labelling.

Agency Publication Date: June 28, 2024
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Summary

Applied Medical Technology Inc. is recalling 74 units of the AMT Initial Placement Dilator Set, which is used during the placement of gastrostomy (feeding) devices. The recall was initiated because these devices were labeled with the incorrect guidewire information, which could lead to confusion or the use of improper components during a medical procedure. If you have these devices, you should contact your healthcare provider or the manufacturer immediately for guidance on return or replacement.

Risk

The incorrect labeling on the guidewire packaging can lead to the use of incompatible components or improper surgical technique during the placement of a feeding tube, which may result in procedural delays or medical complications.

What You Should Do

  1. Identify if you have the AMT Initial Placement Dilator Set by checking the packaging for Model Number IP-DIL and UDI-DI 00842071131876.
  2. Check the specific lot number on your device packaging for Lot Number 231218-242 with an expiration date of 2026-11-01.
  3. Contact your healthcare provider or the manufacturer, Applied Medical Technology Inc., at their Brecksville, Ohio office for instructions on how to handle the affected product and obtain a potential replacement or refund.
  4. For any additional questions regarding this recall, contact the FDA medical device hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification

How to: The firm initiated the recall via a notification letter to affected customers.

Affected Products

Product: AMT Initial Placement Dilator Set
Model / REF:
IP-DIL
UPC Codes:
00842071131876
Lot Numbers:
231218-242
Date Ranges: Exp. Date: 2026-11-01

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94702
Status: Resolved
Manufacturer: Applied Medical Technology Inc
Manufactured In: United States
Units Affected: 74 units

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.