Reported Aug 20, 2025 · Ongoing

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

Diversatek Healthcare

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Diversatek Healthcare · 9150 Commerce Center Cir Ste 500 · Highlands Ranch, CO · 80129-1563

Is this the product you have?

  • Zvu Anorectal Manometry Procedure Kit
  • REFHRAM-PROC-10
Lot codes and dates
  • UDI-DI00816734022863
  • Lot24752
Amount recalled
8

Where it was sold

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.