Merit Medical Custom Procedure Kit Recall: 7F Sheath Introducers Labeled 7.5F
Merit Medical recalls Custom Procedure Kit REF K12T-11077 with 7F sheath introducers labeled as 7.5F. This mismatch may cause improper use during medical procedures.
Lower-risk recall
7F sheath introducers labeled as 7.5F
Contact the company
What happened, in plain English
Merit Medical is recalling a Custom Procedure Kit (REF: K12T-11077) because some sheath introducers are labeled 7.5F instead of 7F. This mismatch could lead to improper use during medical procedures if the wrong size is used. Read more at govinfonow.com/recall/54240-merit-medical-custom-procedure-kit-recall-7f-sheath-introducers-labeled.
Source Summary by GovInfoNow · govinfonow.com/recall/54240-merit-medical-custom-procedure-kit-recall-7f-sheath-introducers-labeled · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3191-2024
Cite this page
“Merit Medical Custom Procedure Kit Recall: 7F Sheath Introducers Labeled 7.5F.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54240-merit-medical-custom-procedure-kit-recall-7f-sheath-introducers-labeled. Based on FDA recall #Z-3191-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3191-2024%22&limit=1).
Why it’s dangerous
The sheath introducers are labeled as 7.5F instead of 7F. This size mismatch could cause improper use during medical procedures if the wrong size is used, potentially leading to incorrect procedure outcomes.
Who’s affected
Medical professionals using the Custom Procedure Kit with the specific reference number K12T-11077 are likely affected. The risk is low as this is a labeling error rather than a safety hazard.
How to tell if you have this one
Check for the reference number K12T-11077 on the kit. The expiration date is December 1, 2024, and the lot number is 00884450457863.
- Brand
Merit Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3190-2024 | Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F); REF/UDI-DI/Lot (Expiration Date): PSI-7F-11-038 Version F/00884450708835/H2874685 (09-Mar-2027), H2878374 (26-FEB-2027), H2904232 (11-MAY-2027) | 1892 |
| Z-3191-2024 | Custom Procedure Kit, REF: K12T-11077; REF/UDI-DI/Lot (Expiration Date): K12T-11077/00884450457863/T2908313 (01-DEC-2024) | 24 |
What to do — step by step
Check Product Label
Look for the reference number K12T-11077 and expiration date December 1, 2024.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Georgia, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Wisconsin.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-3191-2024 (August 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3191-2024 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.