FDAFDA · Food and drugs·Recall number Z-2324-2025
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Published August 20, 2025 · Recall initiated: June 4, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Diversatek Healthcare
- Distributor
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
- Lot
- UDI-DI: 00816734022863, Lot: 24752
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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