AllClear
PricingSign in
FDAJanuary 27, 2025device

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

What to do

FDA enforcement status: Ongoing

Brands named

merit medical systemsmeritmerit medical

UPCs

00884450693919

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D — Recall Details · AllClear