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FDAMarch 27, 2025device

Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

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

The hazard

Due to a potential open seal in the sterile barrier packaging.

What to do

FDA enforcement status: Ongoing

Brands named

galt medicalgalt

UPCs

00841268102729

Recall history

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

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Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires — Recall Details · AllClear