Zvu Anorectal Manometry Procedure Kit recalled over labeling errors

Recall date

June 4, 2025

Source

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

Official notice title

Diversatek Healthcare recalls Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Recall number

Z-2324-2025

FDA classification

Class III

Brand / firm

Diversatek Healthcare

Sold / distributed

Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.

Why it was recalled

Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10