Hemostasis valves recalled because the valve cap may remain depressed
Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states a stuck valve cap can leak and may result in hemorrhage, and no injuries are reported.
Plain-English summary
The Merit Medical PhD Hemostasis Valve is being recalled across REFs including IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, MAP800/B, MAP802/B and SKY1802.
The hemostasis valve has a manufacturing defect and, when used, the valve cap may remain depressed, leading to potential leakage. Merit Medical states this may result in procedure inconvenience and/or hemorrhage.
The recall covers 217,141 units, including UDI-DI 00884450638385 for REF IN4802/K. The product was distributed across the United States including Pennsylvania, Arizona, Louisiana, Colorado, Florida, North Carolina, South Carolina, Ohio, Alaska, Illinois, Iowa, Minnesota, Texas and Wisconsin. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Merit Medical's instructions.
The recalled product
- 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.
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Vascular access
- Affected units
- 217,141
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lot(Expiration): IN4802/K/00884450638385/I3138883(20-FEB-2028)
- I3150031(27-FEB-2028)
- I3161209(10-MAR-2028)
- I3161210(08-APR-2028)
- I3161211(17-MAR-2028)
- I3172451(30-NOV-2026)
- IN4802/T/00884450860113/I3135188(30-NOV-2026
- I3170171(10-MAR-2028
- IN4918/A/00884450638521/I3146050(20-FEB-2028)
- I3200779(19-MAY-2028)
- IN7802/C/00884450498743/H3143753(30-NOV-2026)
- H3162387(14-MAR-2028)
- H3183068(31-MAR-2028)
- H3189446(29-FEB-2028)
- H3213617(31-MAY-2028)
- IN8802/C/00884450621417/H3141570(02-FEB-2028)
- H3143769(03-FEB-2028)
- H3143770(31-DEC-2026)
- H3143771(03-FEB-2028)
- H3143772(03-FEB-2028)
Distribution
Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- ModerateMerit Medical Systems Recalls Scout MD Delivery Systems Due to Deployment Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Same hazard · valve defect
See all →- HighRescuMed Manual Resuscitators Recalled for CO2 Rebreathing Risk
FDA (Devices) · 2023-11-29
- HighPhilips Ingenia MRI System recalled due to incorrect pressure relief valve
FDA (Devices) · 2021-09-01
- HighDiagnostic MRI system recalled for pressure relief valve defect
FDA (Devices) · 2021-09-01
- HighMRI System Pressure Relief Valve Defect May Release Helium Gas
FDA (Devices) · 2021-09-01
- HighConvaTec Recalls Non-Rebreathing Masks and Reservoir Bags Due to Valve Defect
FDA (Devices) · 2017-06-14
Similar recalls
- HighAccessPLUS hemostasis valves recalled for internal guidewire entrapment risk
FDA (Devices) · 2022-04-20
- HighAccess-9 Hemostasis Valves Recalled for Guidewire Entrapment Risk
FDA (Devices) · 2022-04-20
- HighHemostasis valves recalled because deformed quad rings may shed foreign bodies
FDA (Devices) · 2025-09-17
- HighAspira Valve Repair Kit may fail to open and obstruct fluid drainage
FDA (Devices) · 2023-06-21
- HighVascular Solutions Recalls Guardian II Hemostasis Valves Due to Missing Seals
FDA (Devices) · 2012-09-26
- HighMicrocatheter and Infusion Systems Recalled Due to Sterility Concerns
FDA (Devices) · 2024-01-10