FDA Medical devices recall ·
Zvu Anorectal Manometry Procedure Kit recall
- Recall number
- Z-2324-2025
- Date
- (initiated June 4, 2025)
- Company / brand
- Diversatek Healthcare
9150 Commerce Center Cir Ste 500, Highlands Ranch, CO, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 8
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00816734022863, Lot: 24752
Distribution
Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
States: Colorado Massachusetts New Mexico Ohio
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-2324-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.