FDA Device recall Z-2238-2024
AMT Initial Placement Dilator Set
- FDA Device
- Class II
- completed
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class II recall of AMT Initial Placement Dilator Set by Applied Medical Technology, citing devices were labelled with the incorrect guidewire labelling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2238-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-05-14 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Applied Medical Technology |
| Distribution | US |
Product
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
Reason
Devices were labelled with the incorrect guidewire labelling.
Identifiers
| code_info | Model No: IP-DIL; UDI-DI: 00842071131876; Lot number: 231218-242; Exp. Date: 2026-11-01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2238-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.