FDA Medical Device Recalls (openFDA)
Applied Medical Technology Inc: AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
- Recall number
- Z-2238-2024
- Recalling firm
- Applied Medical Technology Inc
- Product
- AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
- Status
- Completed
- Initiated
- 2024-05-14
- Posted
- 2024-06-28
- Terminated
- not on file
- Reason
- Devices were labelled with the incorrect guidewire labelling.
- 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 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.
- Quantity
- 74 units
- Distribution
- US Nationwide distribution in the states of GA, IL, IN, LA, NC, NE, SC, TN, TX, UT, VA, WA, & WV.
- Lot, serial or model codes
- Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01.
- 510(k) numbers
- ["K073034"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1526012
- Firm city
- Brecksville
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28