---
title: "Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 — FDA record Z-2324-2025 | Is It on Recall"
description: "Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration da"
url: https://isitonrecall.com/recall/fda-device-z-2324-2025-zvu-anorectal-manometry-procedure-kit-ref-hram-proc-10/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 — FDA record Z-2324-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 4, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- **Reason**: 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.
- **Classification**: Class III
- **Recalling firm**: Diversatek Healthcare
- **Quantity**: 8
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2324-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2324-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 00816734022863, Lot: 24752 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)
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- [Arizona](https://isitonrecall.com/state/arizona/)
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- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Delaware](https://isitonrecall.com/state/delaware/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Hawaii](https://isitonrecall.com/state/hawaii/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Maine](https://isitonrecall.com/state/maine/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
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- [Montana](https://isitonrecall.com/state/montana/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [North Dakota](https://isitonrecall.com/state/north-dakota/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
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- [New Jersey](https://isitonrecall.com/state/new-jersey/)
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- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
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- [Wisconsin](https://isitonrecall.com/state/wisconsin/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)
- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Aug 20, 2025
- **Recall initiation date**: Jun 4, 2025
- **Center classification date**: Aug 14, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2324-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Diversatek Healthcare records](https://isitonrecall.com/brand/diversatek-healthcare/)