Reported Nov 26, 2025 · Ongoing

PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,…

Merit Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416

Is this the product you have?

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 and dates: 19 of 19 products
Products covered by this recall
# Barcodes Product as published
1 00884450638385 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)
2 00884450860113 IN4802/T/00884450860113/I3135188(30-NOV-2026, I3170171(10-MAR-2028
3 00884450638521 IN4918/A/00884450638521/I3146050(20-FEB-2028), I3200779(19-MAY-2028)
4 00884450498743 IN7802/C/00884450498743/H3143753(30-NOV-2026), H3162387(14-MAR-2028), H3183068(31-MAR-2028), H3189446(29-FEB-2028), H3213617(31-MAY-2028)
5 00884450621417 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)
6 00884450413463 IN9802/00884450413463/H3141573(21-MAR-2028), H3183200(28-MAR-2028)
7 00884450021347 IN9802/A/00884450021347/H3200469(26-APR-2028), H3210336(30-NOV-2026)
8 00884450499597 K05-02166B/00884450499597/T3192808(24-FEB-2027), T3198985(11-AUG-2027), T3201276(27-FEB-2027), T3217490(02-SEP-2027)
9 00884450095607 K05T-02138A/ 00884450095607 T3232335(15-AUG-2027)
10 00884450544372 K12T-10798A/00884450544372/T3163727(21-MAY-2027), T3217266(20-FEB-2026)
11 00884450746714 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)
12 00884450003985 MAP800/T/00884450003985/I3162929(10-MAR-2028), I3162931(17-MAR-2028), I3186954(17-MAR-2028), I3186961(15-APR-2028)
13 00884450746721 MAP801/B/00884450746721/I3146099 (24-MAR-2028), I3186946(21-APR-2028), I3209937(31-DEC-2026)
14 00884450746745 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)
15 00884450746752 MAP802/CNB/00884450746752/I3174740(08-APR-2028)
16 00884450860939 MAP802/T/00884450860939/I3162943(17-MAR-2028), I3192650(08-APR-2028), I3192654(22-APR-2028)
17 00884450746783 MAP804/B/00884450746783/I3146101(31-OCT-2027), I3161426(31-DEC-2027)
18 00884450746820 MAP852/B/00884450746820/I3187883(28-FEB-2028)
19 00884450822500 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)
Amount recalled: 217,141

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Merit Medical Systems, Inc.

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Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers… Jan 28, 2026
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42… Sep 17, 2025
High Pressure Tubing Aug 20, 2025

53 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`00884450638385`	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)
2	`00884450860113`	IN4802/T/00884450860113/I3135188(30-NOV-2026, I3170171(10-MAR-2028
3	`00884450638521`	IN4918/A/00884450638521/I3146050(20-FEB-2028), I3200779(19-MAY-2028)
4	`00884450498743`	IN7802/C/00884450498743/H3143753(30-NOV-2026), H3162387(14-MAR-2028), H3183068(31-MAR-2028), H3189446(29-FEB-2028), H3213617(31-MAY-2028)
5	`00884450621417`	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)
6	`00884450413463`	IN9802/00884450413463/H3141573(21-MAR-2028), H3183200(28-MAR-2028)
7	`00884450021347`	IN9802/A/00884450021347/H3200469(26-APR-2028), H3210336(30-NOV-2026)
8	`00884450499597`	K05-02166B/00884450499597/T3192808(24-FEB-2027), T3198985(11-AUG-2027), T3201276(27-FEB-2027), T3217490(02-SEP-2027)
9	`00884450095607`	K05T-02138A/ 00884450095607 T3232335(15-AUG-2027)
10	`00884450544372`	K12T-10798A/00884450544372/T3163727(21-MAY-2027), T3217266(20-FEB-2026)
11	`00884450746714`	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)
12	`00884450003985`	MAP800/T/00884450003985/I3162929(10-MAR-2028), I3162931(17-MAR-2028), I3186954(17-MAR-2028), I3186961(15-APR-2028)
13	`00884450746721`	MAP801/B/00884450746721/I3146099 (24-MAR-2028), I3186946(21-APR-2028), I3209937(31-DEC-2026)
14	`00884450746745`	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)
15	`00884450746752`	MAP802/CNB/00884450746752/I3174740(08-APR-2028)
16	`00884450860939`	MAP802/T/00884450860939/I3162943(17-MAR-2028), I3192650(08-APR-2028), I3192654(22-APR-2028)
17	`00884450746783`	MAP804/B/00884450746783/I3146101(31-OCT-2027), I3161426(31-DEC-2027)
18	`00884450746820`	MAP852/B/00884450746820/I3187883(28-FEB-2028)
19	`00884450822500`	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)