PhD Hemostasis Valve — Class II medical device recall Z-0533-2026
Ongoing recall by Merit Medical Systems, Inc., reported 2025-11-26, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to poten
| Recall number | Z-0533-2026 |
|---|---|
| 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 | 2025-08-04 |
| Classified | 2025-11-17 |
| Reported by FDA | 2025-11-26 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AU, BE, CA, CH, CN, CY, DE, ES, FI, FR, GB, IS, IT, JP, KR, MX, NL, NO, NZ, OM, PT, QA, SA, SE, SK, TH, TW, VN, ZA |
| Quantity | 217,141 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00884450003985, 00884450021347, 00884450095607, 00884450413463, 00884450498743, 00884450499597, 00884450544372, 00884450621417, 00884450638385, 00884450638521, 00884450746714, 00884450746721, 00884450746745, 00884450746752, 00884450746783, 00884450746820, 00884450822500, 00884450860113, 00884450860939 |
| Lot numbers | K05T-02138A, MAP800/B |
| Model numbers | IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802 |
Product
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
Reason for recall
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
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-0533-2026. 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.