FDA Medical devices recall · November 26, 2025

PhD Hemostasis Valve recall

Read the official FDA notice ↗

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.

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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), H3149478(17-FEB-2028), H3149480(31-DEC-2026), H3149483(31-DEC-2026), H3155549(24-FEB-2028), H3162422(14-MAR-2028), H3162627(14-MAR-2028), H3168247(07-MAR-2028), H3183054(31-DEC-2026), H3200495(26-APR-2028), H3219087(10-JUN-2028), H3241812(31-MAY-2028); IN9802/00884450413463/H3141573(21-MAR-2028), H3183200(28-MAR-2028); IN9802/A/00884450021347/H3200469(26-APR-2028), H3210336(30-NOV-2026); K05-02166B/00884450499597/T3192808(24-FEB-2027), T3198985(11-AUG-2027), T3201276(27-FEB-2027), T3217490(02-SEP-2027); K05T-02138A/ 00884450095607 T3232335(15-AUG-2027); K12T-10798A/00884450544372/T3163727(21-MAY-2027), T3217266(20-FEB-2026); MAP800/B/ 00884450746714/I3124454(07-JAN-2028), I3174736(10-MAR-2028), I3186951(24-MAR-2028), I3191334(01-APR-2028), I3206933(21-APR-2028), I3209939(29-APR-2028), I3219784(12-MAY-2028), I3219792(12-MAY-2028), I3234557(19-MAY-2028), I3234558(26-MAY-2028); MAP800

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, Italy, Spain, Sweden, Norway, Germany, France, Belgium, Netherlands, Thailand, New Zealand, Mexico, Puerto Rico, Canada, Korea, Republic of, South Africa, Qatar, Iceland, United Kingdom, Viet Nam, Slovakia, Guam, Oman, Portugal, Madagascar, Saudi Arabia, Finland, Cyprus, Switzerland, Taiwan, China, Japan

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

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0533-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.