Applied Medical Technology Inc AMT Initial Placement Dilator Set. Used to place gastrostomy devices. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Brand
Applied Medical Technology Inc
Lot Codes / Batch Numbers
Model No: IP-DIL, UDI-DI: 00842071131876, Lot number: 231218-242, Exp. Date: 2026-11-01.
Products Sold
Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
Applied Medical Technology Inc is recalling AMT Initial Placement Dilator Set. Used to place gastrostomy devices. due to Devices were labelled with the incorrect guidewire labelling.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices were labelled with the incorrect guidewire labelling.
Recommended Action
Per FDA guidance
Consignees were mailed an URGENT: MEDICAL DEVICE RECALL letter, dated 5/14/24. Consignees are instructed to not use recalled product and complete the provided acknowledgement form to coordinate return of affected devices by fax to 440-717-4200 or by email to cs@appliedmedical.net. The firm will replace or refund any affected devices returned. Consignees are instructed to continue inspecting product prior to its use according to the IFU and good medical practices. Consignees with any questions can contact the firm by phone at 440-717-4000 from the hours of 8:30 AM to 5:00 PM EST.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026