Class II U.S. Food and Drug Administration

Merit Medical Systems, Inc. PhD recall: Hemostasis valve has a manufacturing defect and when used the valve cap

Recall published 11 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0533-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Merit Medical Systems, Inc.
Product type
Medical devices
Units affected
217,141
Distribution
Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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
Made in
United States
Lot / code info
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)
UPC codes
00884450638385, 00884450860113, 00884450638521, 00884450498743, 00884450621417, 00884450413463, 00884450021347, 00884450499597, 00884450095607, 00884450544372, 00884450746714, 00884450003985, 00884450746721, 00884450746745, 00884450746752, 00884450860939, 00884450746783, 00884450746820, 00884450822500

Products covered by this recall

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.

Check your product

The notice names 23 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00884450638385
  • 00884450860113
  • 00884450638521
  • 00884450498743
  • 00884450621417
  • 00884450413463
  • 00884450021347
  • 00884450499597
  • 00884450095607
  • 00884450544372
  • 00884450746714
  • 00884450003985
  • 00884450746721
  • 00884450746745
  • 00884450746752
  • 00884450860939
  • 00884450746783
  • 00884450746820
  • 00884450822500

Model or item number

On the rating label, the box or the instruction sheet.

  • IN4802
  • IN4918
  • IN7802
  • IN8802

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Merit Medical Systems, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Merit Medical Systems, Inc. medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884450638385, 00884450860113, 00884450638521; model number IN4802, IN4918, IN7802. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Which states were affected?

The notice lists Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam and others.

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