AMT Initial Placement Dilator Set Recalled Due to Incorrect Guidewire Labeling
Applied Medical Technology is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL) due to incorrect guidewire labeling. The labeling error could result in improper guidewire selection during gastrostomy placement procedures.
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 FDA Class II recall involves a labeling error on a medical device where injury has not been reported. The incorrect guidewire labeling creates a risk of improper device selection during a medical procedure, meeting the rubric criterion for High-severity risk-of-harm products without reported injury.
Plain-English summary
Applied Medical Technology Inc is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL, Lot 231218-242). These devices are used to place gastrostomy tubes and were distributed nationwide to facilities in 13 states: Georgia, Illinois, Indiana, Louisiana, North Carolina, Nebraska, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia.
The devices were labeled with incorrect guidewire labeling. This labeling error could result in the selection of an incorrect guidewire during gastrostomy placement procedures.
Healthcare facilities that received this device should immediately discontinue use of the affected lot and contact Applied Medical Technology Inc for replacement or return instructions. If this device was used in patients, healthcare providers should review medical records to identify those cases.
For additional information, contact Applied Medical Technology Inc or report any adverse events to the FDA's MedWatch program.
The recalled product
- Product
- AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
- Manufacturer
- Applied Medical Technology Inc
- Hazard
- labeling-error
- guidewire-error
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 (4)
- Model No: IP-DIL
- UDI-DI: 00842071131876
- Lot number: 231218-242
- Exp. Date: 2026-11-01.
Distribution
Distributed nationwide across the United States.
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