FDA Device recall Z-1736-2025
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
- FDA Device
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires by Galt Medical, citing due to a potential open seal in the sterile barrier packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1736-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-27 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Galt Medical |
| Distribution | US |
Product
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Reason
Due to a potential open seal in the sterile barrier packaging.
Identifiers
| code_info | Catalog Number: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1736-2025%22
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