Lower risk Medical device recall · FDA · Published August 4, 2025

Merit Medical PhD Hemostasis Valve Recall: Cap May Remain Depressed Causing Leakage

Merit Medical recalls PhD Hemostasis Valves with specific model numbers due to a manufacturing defect that may cause leakage, leading to procedure inconvenience or hemorrhage.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0533-2026Medical device Merit Medical ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416

✎ GovInfoNow plain-language explainer

Merit Medical is recalling certain PhD Hemostasis Valves because a manufacturing defect can cause the valve cap to stay depressed, potentially leading to leakage during medical procedures. This could result in procedure delays or bleeding. Read more at govinfonow.com/recall/51703-merit-medical-phd-hemostasis-valve-recall-cap-may-remain-depressed.

Source Summary by GovInfoNow · govinfonow.com/recall/51703-merit-medical-phd-hemostasis-valve-recall-cap-may-remain-depressed · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0533-2026

Cite this page

“Merit Medical PhD Hemostasis Valve Recall: Cap May Remain Depressed Causing Leakage.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51703-merit-medical-phd-hemostasis-valve-recall-cap-may-remain-depressed. Based on FDA recall #Z-0533-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2026%22&limit=1).

The FDA announced on 2025-08-04 that Merit Medical Systems, Inc. is recalling PhD Hemostasis Valves due to a manufacturing defect that may cause the valve cap to remain depressed, leading to potential leakage. This issue could result in procedure inconvenience and/or hemorrhage.

How to tell if you have it

Merit Medical 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
Lot codes: I3138883, I3150031, I3161209, I3161210, I3172451, I3135188, I3170171, I3146050, I3200779, H3143753, H3162387, H3183068, H3189446, H3213617, H3141570, H3143769, H3143770, H3143771, H3143772, H3149478, H3149480, H3149483, H3155549, H3162422, H3162627, H3168247, H3183054, H3200495, H3219087, H3241812, H3141573, H3183200, H3200469, H3210336, T3192808, T3198985, T3201276, T3217490, T3232335, T3163727, T3217266, I3124454, I3174736, I3186951, I3191334, I3206933, I3209939, I3219784, I3219792, I3234557, I3234558, I3162929, I3162931, I3186954, I3186961, I3146099, I3186946, I3209937, I3118322, I311832407-JAN-2028, I3129725, I3129726, I3150110, I3150111, I3162940, I3162942, I3174729, I3174730, I3192937, I3200996, I3209935, I3215925, I3215926, I3215928, I3219783, I3219785, I3219786, I3230013, I3174740, I3162943, I3192650, I3192654, I3146101, I3161426, I3187883, H3079946, H3141576, H3141577, H3149507, H3149508, H3155575, H3155576, H3155577, H3155578, H3168264, H3168265, H3182996, H3183206, H3183207, H3189428, H3189451, H3200416, H3200475, H3219111

The hazard

According to the FDA, the hemostasis valve has a manufacturing defect where the valve cap may remain depressed when used. This defect can lead to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

Context

GovInfoNow's records show Merit Medical Systems, Inc. has 37 other recalls on record since 2006-02-24. Other recent recalls of similar products include Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam (2026-08-10), Splashwire Hydrophilic Guide Wire Recall (2026-05-08), Philips Bridge Prep Kit Recall (2026-04-02), Medtronic EOPA Arterial Cannula Recall (2026-06-24), AVID Medical Halyard Arteriogram Recall (2025-11-14), and Medtronic Perfusion Systems EOPA Cannula Recall (2026-06-24).

How to tell if you have this one

Check the product model numbers listed in the recall notice: 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.

Brand
Merit Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Model
Identify the model number on the valve to see if it matches the recalled list.

Where it went and when

Where it was distributed

Distributed in 48 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, MS, WV, SD, DE, NV, ND. OUS: United Arab Emirates, Australia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 4 months after the firm started it.

Aug 4, 2025Firm started the recall
Nov 17, 2025FDA classified it Class II
Nov 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51703-merit-medical-phd-hemostasis-valve-recall-cap-may-remain-depressed">Merit Medical PhD Hemostasis Valve Recall: Cap May Remain Depressed Causing Leakage (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0533-2026 (August 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0533-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.