FDA Device recall Z-2553-2025
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10F…
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10F… by Merit Medical Systems, citing due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2553-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-25 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.
Reason
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Identifiers
| code_info | Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 Lot Numbers: H3098831 H3111155 H3152503 H3155611 H3186901 MAPTE…Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 Lot Numbers: H3098831 H3111155 H3152503 H3155611 H3186901 MAPTEN42 / 00884450832509 Lot Numbers: H3076189 H3111156 H3152504 H3155614 H3173674 MAPTEN452 / 00884450821329 Lot Number: H3111162 |
|---|
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-2553-2025%22
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