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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