Z-0533-2026Class II

PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B...

Name: Z-0533-2026 PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B...
Creator: Merit Medical Systems, Inc.
Published: 2025-08-04
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2025-08-04 / Open, Classified / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of 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... on 2025-08-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0533-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-04
Posted: 2025-11-17
Recalling firm: Merit Medical Systems, Inc.
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.
Product code: DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Reason for 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.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: On 8/4/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Identify affected devices, quarantine, discontinue use, and distribution. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. Additional distribution details may be required by health authorities. 4) Complete and return the customer response form via email to [email protected] 5. Return all affected lots to Merit, per the instructions in the customer response form. If you have any questions concerning this communication, please contact the firm at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.
Quantity in commerce: 217,141
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
Product codes and lots: 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/T/00884450003985/I3162929(10-MAR-2028), I3162931(17-MAR-2028), I3186954(17-MAR-2028), I3186961(15-APR-2028); MAP801/B/00884450746721/I3146099 (24-MAR-2028), I3186946(21-APR-2028), I3209937(31-DEC-2026); MAP802/B/00884450746745/I3118322(21-JAN-2028), I311832407-JAN-2028), I3129725(06-FEB-2028), I3129726(06-FEB-2028), I3150110(20-FEB-2028), I3150111(20-FEB-2028), I3162940(27-FEB-2028), I3162942(03-MAR-2028), I3174729(03-MAR-2028), I3174730(17-MAR-2028), I3192937(15-APR-2028), I3200996(15-APR-2028), I3209935(29-APR-2028), I3215925(29-APR-2028), I3215926(30-APR-2028), I3215928(05-MAY-2028), I3219783(30-APR-2028), I3219785(19-MAY-2028), I3219786(19-MAY-2028), I3230013(26-MAY-2028); MAP802/CNB/00884450746752/I3174740(08-APR-2028); MAP802/T/00884450860939/I3162943(17-MAR-2028), I3192650(08-APR-2028), I3192654(22-APR-2028); MAP804/B/00884450746783/I3146101(31-OCT-2027), I3161426(31-DEC-2027); MAP852/B/00884450746820/I3187883(28-FEB-2028); SKY1802/00884450822500/H3079946(20-OCT-2027), H3141576(21-MAR-2028), H3141577(21-MAR-2028), H3149507(28-MAR-2028), H3149508(28-MAR-2028), H3155575(21-MAR-2028), H3155576(21-MAR-2028), H3155577(21-MAR-2028), H3155578(14-MAR-2028), H3168264(29-FEB-2028), H3168265(29-FEB-2028), H3182996(28-MAR-2028), H3183206(31-MAR-2028), H3183207(31-MAR-2027), H3189428(12-APR-2028), H3189451(12-APR-2028), H3200416(19-APR-2028), H3200475(19-APR-2028), H3219111(30-NOV-2026)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0533-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0533-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-17

Product code DTL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)