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FDAJune 4, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

diversatek healthcarediversatek

UPCs

00816734022863

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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