10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 /… — Class II medical device recall Z-2553-2025
Ongoing recall by Merit Medical Systems, Inc., reported 2025-09-17, distributed nationwide. Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged
| Recall number | Z-2553-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2025-07-25 |
| Classified | 2025-09-11 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KR |
| Quantity | 447 |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 00884450821305, 00884450821329, 00884450832509 |
| Lot numbers | H3076189, H3098831, H3111155, H3111156, H3111162, H3152503, H3152504, H3155611, H3155614, H3173674, H3186901, MAPTEN42, MAPTEN452 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2553-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.