Use cautionMedical device recall · FDA · Published September 12, 2019
Merit Medical Custom Sheath Kit: Incorrect Size Risk of Bleeding and Clots
Merit Medical recalls Custom Sheath Introducer Kit REF K21-0: incorrect sheath size included may cause bleeding, clots, or blockages during medical procedures.
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
Take action
Contact the company
📍Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416
“Merit Medical Custom Sheath Kit: Incorrect Size Risk of Bleeding and Clots.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67025-merit-medical-custom-sheath-kit-incorrect-size-risk-of-bleeding. Based on FDA recall #Z-1956-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1956-2020%22&limit=1).
Merit Medical Systems, Inc. recalled the Custom Sheath Introducer Kit REF K21-00031 due to a labeling error that may result in vasoconstriction, hemorrhage, or embolism, according to the FDA on September 12, 2019.
How to tell if you have it
Brand: Merit Medical Systems
Product: Custom Sheath Introducer Kit
REF: K21-00031
Catalog Number: K21-00031
Lot Number: H1583914
UDI: 00884450426357
Distribution: US Nationwide distribution in the state of MI
The hazard
Due to a manufacturing issue, the product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
Context
GovInfoNow's records show Merit Medical Systems, Inc. has 37 other recalls on record since February 24, 2006. Other recent recalls of similar products include Embosphere 500-700 Micrometer Syringe Recall (August 10, 2026), Merit Medical Splashwire Hydrophilic Guide Wire Recall (May 8, 2026), and Philips Bridge Prep Kit Recall (April 2, 2026).
How to tell if you have this one
Check for the catalog number K21-00031 and lot number H1583914 on the product packaging. The kit was sold with incorrect sheath sizes and assemblies.
Brand
Merit Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Components
Verify the sheath size and assembly matches the product label and catalog number K21-00031.
Contact Manufacturer
Reach out to Merit Medical Systems for assistance with the correct kit components.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of MI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1956-2020 (September 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1956-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.