Z-2238-2024Class II

AMT Initial Placement Dilator Set. Used to place gastrostomy devices

Name: Z-2238-2024 AMT Initial Placement Dilator Set. Used to place gastrostomy devices
Creator: Applied Medical Technology Inc
Published: 2024-05-14
License: https://open.fda.gov/license/

Applied Medical Technology Inc / initiated 2024-05-14 / Completed / root cause: manufacturing process

FDA source

Applied Medical Technology Inc began a recall of AMT Initial Placement Dilator Set. Used to place gastrostomy devices on 2024-05-14. FDA classified it as Class II and gives the reason as "Devices were labelled with the incorrect guidewire labelling". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2238-2024
Classification: Class II
Status: Completed
Initiated: 2024-05-14
Posted: 2024-06-28
Recalling firm: Applied Medical Technology Inc
Product: AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Devices were labelled with the incorrect guidewire labelling.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 74 units
Distribution: US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
Product codes and lots: Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2238-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2238-2024	Class II	Completed	Voluntary: Firm initiated	2024-07-10	2024-06-28

Product code KNT

K073034Class IIAmt Initial Placement Gi Kit (E2418) and Amt Dilator Set (E2419)Applied Medical Technology, Inc. / cleared 2008-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)