Merit Medical recalls Prelude IDEAL 4F Hydrophilic Sheath Introducers that may contain 5F dilators, causing procedure delays. Affected units have specific reference numbers and expiration dates.
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
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Contact the company
📍Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416
“Merit Medical Prelude IDEAL 4F Hydrophilic Sheath Introducer Recall: Incorrect Dilator.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53026-merit-medical-prelude-ideal-4f-hydrophilic-sheath-introducer-recall-incorrect. Based on FDA recall #Z-1434-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1434-2025%22&limit=1).
The FDA announced on Jan. 27, 2025, that Merit Medical Systems is recalling the Prelude IDEAL 4 F Hydrophilic Sheath Introducer because it may incorrectly contain 5F dilators instead of the labeled 4F size. This error could result in procedure delays for users.
How to tell if you have it
Brand: Merit Medical
Product: Prelude IDEAL 4 F Hydrophilic Sheath Introducer
REF: PID4F16021PW/D
UDI-DI: 00884450693919
Lot: H3082668
Expiration: 14-Nov-24
Quantity: 40 units distributed to Japan
The hazard
The hydrophilic sheath introducer is labeled for 4F dilators but may incorrectly contain 5F dilators. According to the FDA, incorrect dilator use may result in procedure delay.
Context
GovInfoNow's records show Merit Medical Systems has issued 37 other recalls since Feb. 24, 2006. Recent brand recalls include an Aug. 10, 2026, Embosphere syringe recall for packaging holes and a May 8, 2026, Splashwire guide wire recall for unsealed pouches. Other recent recalls of similar products include a March 18, 2026, Diversatek Viper balloon dilator recall for incorrect part numbers and inflation tags, and a March 11, 2026, Arrow Percutaneous sheath introducer recall for incorrect adhesive manufacturing.
How to tell if you have this one
Check for the reference number PID4F16021PW/D on the product. The expiration date is November 14, 2024. The lot number is H3082668.
Brand
Merit Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the reference number and expiration date on the sheath introducer.
How this recall unfolded
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1434-2025 (January 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1434-2025 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.