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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Merit Medical PhD Hemostasis Valves Recalled for Potential Leakage

Agency Publication Date: November 17, 2025
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Summary

Merit Medical Systems, Inc. is recalling approximately 217,141 PhD Hemostasis Valves due to a manufacturing defect where the valve cap may stay pressed down during use. This issue can lead to fluid leaking from the device, which may cause medical procedures to be interrupted or result in significant patient bleeding (hemorrhage). This recall affects a wide range of models and lot numbers manufactured in the United States.

Risk

A malfunctioning valve cap can remain depressed, causing an open path for fluid or blood to leak out of the device. This poses a risk of hemorrhage and could compromise the safety of patients undergoing medical procedures where these valves are used.

What You Should Do

  1. This recall affects Merit Medical PhD Hemostasis Valves sold under several catalog (REF) 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, and SKY1802.
  2. Check the product label on the packaging for the catalog number (REF), lot number, and expiration date. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Merit Medical Systems, Inc. or your medical supply distributor to arrange for the return, replacement, or correction of the affected valves.
  5. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: PhD Hemostasis Valve
Model / 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 Numbers (105):
I3138883 (Exp 20-FEB-2028)
I3150031 (Exp 27-FEB-2028)
I3161209 (Exp 10-MAR-2028)
I3161210 (Exp 08-APR-2028)
I3161211 (Exp 17-MAR-2028)
I3172451 (Exp 30-NOV-2026)
I3135188 (Exp 30-NOV-2026)
I3170171 (Exp 10-MAR-2028)
I3146050 (Exp 20-FEB-2028)
I3200779 (Exp 19-MAY-2028)
H3143753 (Exp 30-NOV-2026)
H3162387 (Exp 14-MAR-2028)
H3183068 (Exp 31-MAR-2028)
H3189446 (Exp 29-FEB-2028)
H3213617 (Exp 31-MAY-2028)
H3141570 (Exp 02-FEB-2028)
H3143769 (Exp 03-FEB-2028)
H3143770 (Exp 31-DEC-2026)
H3143771 (Exp 03-FEB-2028)
H3143772 (Exp 03-FEB-2028)
H3149478 (Exp 17-FEB-2028)
H3149480 (Exp 31-DEC-2026)
H3149483 (Exp 31-DEC-2026)
H3155549 (Exp 24-FEB-2028)
H3162422 (Exp 14-MAR-2028)
H3162627 (Exp 14-MAR-2028)
H3168247 (Exp 07-MAR-2028)
H3183054 (Exp 31-DEC-2026)
H3200495 (Exp 26-APR-2028)
H3219087 (Exp 10-JUN-2028)
H3241812 (Exp 31-MAY-2028)
H3141573 (Exp 21-MAR-2028)
H3183200 (Exp 28-MAR-2028)
H3200469 (Exp 26-APR-2028)
H3210336 (Exp 30-NOV-2026)
T3192808 (Exp 24-FEB-2027)
T3198985 (Exp 11-AUG-2027)
T3201276 (Exp 27-FEB-2027)
T3217490 (Exp 02-SEP-2027)
T3232335 (Exp 15-AUG-2027)
T3163727 (Exp 21-MAY-2027)
T3217266 (Exp 20-FEB-2026)
I3124454 (Exp 07-JAN-2028)
I3174736 (Exp 10-MAR-2028)
I3186951 (Exp 24-MAR-2028)
I3191334 (Exp 01-APR-2028)
I3206933 (Exp 21-APR-2028)
I3209939 (Exp 29-APR-2028)
I3219784 (Exp 12-MAY-2028)
I3219792 (Exp 12-MAY-2028)
UDI:
00884450638385
00884450860113
00884450638521
00884450498743
00884450621417
00884450413463
00884450021347
00884450499597
00884450095607
00884450544372
00884450746714
00884450003985
00884450746721
00884450746745
00884450746752
00884450860939
00884450746783
00884450746820
00884450822500
GTIN:
00884450638385
00884450860113
00884450638521
00884450498743
00884450621417
00884450413463
00884450021347
00884450499597
00884450095607
00884450544372
00884450746714
00884450003985
00884450746721
00884450746745
00884450746752
00884450860939
00884450746783
00884450746820
00884450822500

Includes several REF/catalog models of the PhD Hemostasis Valve with corresponding lot numbers and expiration dates.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97446
Status: Active
Manufacturer: Merit Medical Systems, Inc.
Sold By: Medical Supply Distributors
Manufactured In: United States
Units Affected: 217,141
Distributed To: Pennsylvania, Arizona, Louisiana, Colorado, Florida, North Carolina, South Carolina, Ohio, Alaska, Illinois, Iowa, Minnesota, Texas, Wisconsin, Arkansas, New York, California, Kansas, New Jersey, Michigan, Virginia, Kentucky, Alabama, Montana, Nebraska, Massachusetts, Missouri, Tennessee, Connecticut, Maryland, Washington, District of Columbia, Maine, Oregon, New Hampshire, Indiana, Georgia, Utah, Oklahoma, Hawaii, Rhode Island, Idaho, New Mexico, Mississippi, West Virginia, South Dakota, Delaware, Nevada, North Dakota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.