Class III — Diversatek Healthcare
| Recalling firm | DIVERSATEK HEALTHCARE |
|---|---|
| Registered facility | DIVERSATEK HEALTHCARE INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| 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. |
| Product | Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 |
| Quantity | 8 |
| Distribution | Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea. |
| Initiated | 2025-06-04 |
| Classified | 2025-08-14 |
| Recall number | Z-2324-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Diversatek Healthcare (Z-2324-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97282/
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