Mercury Enterprises, Inc. dba Mercury Medical recalls Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Recall date

August 30, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0004-2025

FDA classification

Class I

Brand / firm

Mercury Enterprises, Inc. dba Mercury Medical

Sold / distributed

US distribution to MI, FL, SC, PA, IN. International distribution to Albania.

Why it was recalled

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.