FDA Device recall Z-2324-2025
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- FDA Device
- Class III
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class III recall of Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 by Diversatek Healthcare, citing 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 label….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2324-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-06-04 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Diversatek Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI: 00816734022863, Lot: 24752 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2324-2025%22
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