Lower riskMedical device recall · FDA · Published October 26, 2018
Merit Medical Custom Procedure Kit Recall: Incorrect Latex Labeling
Merit Medical recalls Custom Procedure Kit (K12T-03688) due to incorrect latex labeling. This may cause confusion about whether the kit is latex-free, but does not pose a safety risk.
“Merit Medical Custom Procedure Kit Recall: Incorrect Latex Labeling.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69548-merit-medical-custom-procedure-kit-recall-incorrect-latex-labeling. Based on FDA recall #Z-0026-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0026-2020%22&limit=1).
The FDA announced on 2018-10-26 that Merit Medical Systems, Inc. voluntarily recalled Custom Procedure Kits due to incorrect latex labeling indicating the product was latex-free when it was not. The agency classified this Class II recall as terminated.
How to tell if you have it
Brand: Merit Medical Systems
Product: Custom Procedure Kit, Custom Kit
REF/Product Code: K12T-03688
UPC: 00884450389409
Catalog #: K12T-03688H
Lot codes: T1401193 and T1419935
Distribution: U.S. (VA, IL)
The hazard
The recall addresses a labeling error where the Procedure Kit/Tray contained incorrect latex labeling information, specifically indicating it was Latex Free. The FDA stated this mislabeling was identified during the review process.
Context
GovInfoNow's records show Merit Medical Systems, Inc. has 37 other recalls on record since 2006-02-24. Recent brand recalls include the Embosphere 500-700 Micrometer Syringe Recall (2026-08-10), the Merit Medical Splashwire Hydrophilic Guide Wire Recall (2026-05-08), and the Philips Bridge Prep Kit Recall (2026-04-02). Other recent recalls of similar products include the Medline TRACH TUBE KIT Recall (2026-07-10) and the Medline Medical Procedure Kits Recall (2026-05-04).
How to tell if you have this one
Check for the product code K12T-03688 with lot numbers T1401193 or T1419935. The kit is sold as a single-use, sterile, latex-free product for medical procedures.
Brand
Merit Medical Systems
Product
Merit Medical Systems, Inc. recalls Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI
Category
Medical device
FDA recall event · 2 products
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
Terminated
Distribution
U.S.: VA, IL
Recall number
Product, codes & lots
Quantity
Z-0026-2020
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409; Catalog #K12T-03688H - Lot #T1401193 and #T1419935
88 Kits
Z-0027-2020
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580; Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05
24 kits
Based on the official FDA remedy
What to do — step by step
Verify Product Details
Check the product code and lot numbers on the kit to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in Illinois and Virginia.
Listed by the agency
Not listed
FDA distribution: “U.S.: VA, IL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Virginia.
Recall timeline
FDA terminated this recall 20 months 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-0026-2020 (October 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0026-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.