Diversatek Healthcare: Device Recall
Recall #Z-2324-2025 · 06/04/2025
Class III: Low Risk
Recall Details
- Recall Number
- Z-2324-2025
- Classification
- Class III
- Product Type
- Device
- Recalling Firm
- Diversatek Healthcare
- Status
- Ongoing
- Date Initiated
- 06/04/2025
- Location
- Highlands Ranch, CO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
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.
Product Description
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.