FDA recall Z-2324-2025

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2025-06-04

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Highlands Ranch, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2324-2025