The Recall Desk
HighFDA (Devices)·Z-0533-2026·Announced 2025-11-26

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.

What this means for you

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
Hazard
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

Distributed in 49 states:

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