Class III

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

Diversatek Healthcare · June 4, 2025

Reason for Recall

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

8

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2324-2025

Status: ongoing

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