Zvu Anorectal Manometry Procedure Kit — Class III medical device recall Z-2324-2025
Ongoing recall by Diversatek Healthcare, reported 2025-08-20, distributed nationwide. Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufac
| Recall number | Z-2324-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diversatek Healthcare, Highlands Ranch, CO, United States |
| Recall initiated | 2025-06-04 |
| Classified | 2025-08-14 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR |
| Quantity | 8 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00816734022863 |
| Lot numbers | 24752 |
| Model numbers | HRAM-PROC-10 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2324-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.