AMT Initial Placement Dilator Set recallZ-2238-2024 · Applied Medical Technology Inc · initiated May 14, 2024
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Applied Medical Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices were labelled with the incorrect guidewire labelling.
FDA root cause category: Process control
What the company is doing
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 [email protected]. 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.
Recall details
- Recall number
- Z-2238-2024
- Status
- Completed
- Initiated by the company
- May 14, 2024
- Posted by the FDA
- Jun 28, 2024
- Recalling firm
- Applied Medical Technology Inc
- Quantity
- 74 units
- Product code
- KNT
- FDA submissions
- K073034
- Distribution
- US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Product description
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Code information (models, lots, serial numbers)
Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AMT Initial Placement Dilator Set IP-DILApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)1 recall1 report
Product lines
Other devices under the same FDA submission
1 device cleared under K073034 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- AMT Initial Placement Dilator Set IP-DILApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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