# FDA recall Z-2324-2025

> **Diversatek Healthcare** · Class III · device recall initiated 2025-06-04.

## 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

- **Recall number:** Z-2324-2025
- **Recalling firm:** Diversatek Healthcare
- **Classification:** Class III
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2324-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2324-2025. Source: US FDA. Licensed CC0.

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